Pantoprazole sodium delayed release tablets are indicated for Short Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed release tablets are indicated in adults for the short term treatment (up to 8 weeks) in the healing and symptomatic relief of Erosive Esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pediatric indication and usage information in pediatric patients ages five years and older with Erosive Esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc. s pantoprazole sodium delayed release tablets. However, due to Wyeth Pharmaceuticals Inc. s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed release tablets are indicated for maintenance of healing of Erosive Esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. Pathological Hypersecretory Conditions Including Zollinger Ellison Syndrome Pantoprazole sodium delayed release tablets are indicated for the long term treatment of pathological hypersecretory conditions, including Zollinger Ellison Syndrome. |
Annotated Indication CUIs: C0267055; C0017168; C0043515; |
RXCUIs for this Label: IN=40790 SCDF=373222; SCD=251872;314200; |
Similar Labels: 08098cb2-c048-4640-f387-6beec4a38936;189b7b6a-9717-44eb-b87b-fd3e985b2268;18f7b809-b270-4d44-8065-685bac30efc0;2b872b24-4a06-482e-8716-93d616ccded2;3a8352f0-569d-4d7e-b42a-392feb9e31a5;4b21af6c-486c-4b45-8adb-ae67f7e77ac6;4c8a0544-5e03-47e3-9236-c9646a841e9b;564709e8-358f-c185-4ecb-b3849c3fe59c;56ad5b97-8e5f-48a5-b2ba-a5484b43d018;5e99755f-e72d-4865-a272-a4eb1e940107;6814cd6d-fbb7-4504-8c01-45b31df7b566;6faf465b-c3a3-4ae7-9e16-1ba758f6962a;72f82e7c-fdfb-4d54-8161-944ba00b700e;742ca9f4-9fba-44d4-29a8-1fe3a04f1af6;7969d44b-7776-9a88-c544-eb51496b2b26;7c958802-daad-4c7e-88eb-73be7d2261d8;83c20b13-f3ee-4724-8c8b-18a42460680f;903a60c9-d464-4665-8575-553218f97186;9c983da1-a8e0-479e-8816-5d5668ea242e;a55aea68-42d5-44fc-8916-22b978af5a59;a81dc60e-af42-4d5a-ba21-865fec74ce05;b19238be-9962-478c-bd29-0f5f8d0abef3;b341ddf9-a539-4e29-b72c-e8f5cc247172;c9d84177-bf6b-4df4-9a71-5ea414b0fb99;cfeacb5c-8b1b-48f6-9acf-00044a8179b4;e6238767-90da-4176-8ac6-d71c2025dcb5;e747c09b-98b4-4958-b860-7318b71895ec;e7705bf6-e473-4b9c-bb5d-57e26ffe7b97;ee114ab9-db51-4a71-90b9-cd9865e4fced;f9be6294-9a16-4de1-b346-af0d09a97482; |
Anxiety Disorders Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM III R] diagnosis of generalized anxiety disorder) or the short term relief of symptoms of Anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive Anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or lump in throat ); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or mind going blank because of Anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder Alprazolam is also indicated for the treatment of Panic Disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM III R IV criteria for Panic Disorder (see CLINICAL STUDIES ). Panic Disorder (DSM IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for Panic Disorder; however, patients with Panic Disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0003469;C0030319;C0001818;C0338908; |
RXCUIs for this Label: IN=596 SCDF=370548; SCD=197321;308047;308048; |
Similar Labels: 039c413c-acd2-4e8c-a619-2f48c58ae3c2;041ae7f6-7e42-4803-a015-f3bfcce277ba;082A3791-20C6-4FFA-A113-B60128344381;0b25b6b5-d97d-40a8-8926-7e90a97a5ede;0b781118-9a91-4855-ab7c-669ed73068e9;0bde1207-1433-4861-b6e0-1d723404b44c;0d97256b-77f5-405e-b5be-cded19653180;1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3;13930c94-d83a-414f-be35-b1fef35f738d;175cad46-c9ac-4dd6-a31a-65591b85f899;1e828836-7a09-4b1c-97a8-e88ba9e886ad;2238E083-08F2-0AA8-59B7-16B6D68DBD48;238050FD-5221-4B93-BFCD-31793C9088A7;259387c1-e374-4bc2-9510-5f7f2c60d1a5;263d7c02-ca81-4035-9b3e-5104e8aff086;26ec6e6d-10bc-4ce9-b602-64077d7eaa40;3122efd5-0650-458c-adc9-5c1cfdecef7e;326fa31a-5420-429b-9f7f-170cb38f64bd;3292a8ff-0664-c0a4-42a6-9827ddb93665;366500a0-6e91-4aaf-802a-8966b1c5a3e5;388e249d-b9b6-44c3-9f8f-880eced0239f;3a30a94e-3bd4-45c1-96ad-b8553defda4e;3d621379-9ae9-4874-b9f2-e57a7cf93f29;435f8884-04dd-4609-90a7-4f17425f4222;4440015d-5a5c-4f2e-8993-13a94035d70a;46feeb48-589a-45e3-905c-e2779740fb58;48d8b759-2300-4267-8ab3-b57a087b5bb2;4f6c075f-e2b7-41fa-82c7-eba85cbe27a3;50710e43-bb70-4a2c-a95c-803c3302370d;5abbc5cd-7c71-467e-ab9b-74ff29778420;5bffe9a4-9b4b-4c74-b7ed-ebca90c9c9a1;5c921bf0-0a5a-4408-a3d7-b02f907aa321;5ceed721-2e65-4c81-bd84-f110b1ac9d2e;5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7;634e3ab5-1c6c-423c-9346-9b127cf9646e;676b8fd6-b611-4df1-a52c-2f08b0f4d031;69eee61c-81d7-49e0-ba99-1c6d0d409e5a;747d1977-945d-4f51-b493-757c584fee02;7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3;7cee4c3b-1ee0-42c6-9b3a-cf9d0dd7957b;7d4f450f-ec2b-4770-80f4-382d935aacce;86d1eec6-fb4d-42da-86f4-16ecd9f6a0df;8789eaa5-a568-4453-813b-06fc680e8ba0;8895a5a9-ea0a-406a-8c92-e03bbc3d0bd8;8d0575c8-5556-41ce-9b94-8c013ff69066;92a66ec4-ccca-44bb-8217-41cbcea66270;92efa23c-3fef-4828-8f90-d1c37e8051b5;968291f5-13ce-4a8d-bc1c-657cab5f3229;98c12507-3579-41d5-8b38-2d298daceea6;98cc444a-2c39-4410-8020-aded0a8deb81;9fdaf4dd-2b1c-4193-bae0-9930f8533f1e;a23063c0-099a-4256-b95f-3a857bbf704b;a64496be-bf43-4ba9-a4b1-bd632965c1a0;aa58fff3-c297-49be-838b-599c32ad9835;b19c23b3-d88d-41c3-bea2-789f0898aa86;b5e516a0-d0f4-4613-ab56-b1bb440fcb78;b945ac6f-796e-41ef-85e9-61007e4a4e9a;bb6708c0-0446-40a9-8b68-a8785c7ab061;c4520457-0b0e-493f-805c-c04a788268ee;d0c453e2-1126-4754-be8b-677efde03ffa;d15217da-4445-428f-9430-581bcb567c57;d229aac0-eba9-4d8c-b1e7-d303fea8d7db;d5282c4c-32b4-4f53-9954-0aebdf20038f;d6cbcdd1-ef4e-487f-83a5-176789b449f5;d7a54ceb-2d80-4879-950f-cad362324086;d9b0e228-17cf-40d7-b62e-5050311c571c;db1291e9-ba65-4b6b-83fa-6b6187b17f41;dd915df8-c47e-4bfb-9900-7fe3937e79c1;df6d7793-02ec-4789-ad0e-667956871e55;e10f867c-a6c3-43d1-89da-d82d1def8487;ea350660-9be8-40b2-98f9-af759a8f7864;f025900e-5d16-4614-93ad-7fe08a865458;f3380741-6778-4295-bcb2-2cf66be50b2c;f7736203-7ddb-4461-91da-1924145b2f86;feab3ae1-39a3-4195-8ea3-4a381c0bc454;ff593501-48f7-4ac3-9830-6e9d8d77ce42; |
Amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Intravenous amiodarone also can be used to treat patients with VT VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with intravenous amiodarone, patients may be transferred to oral amiodarone therapy (see DOSAGE AND ADMINISTRATION ). Intravenous amiodarone should be used for acute treatment until the patient s ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but intravenous amiodarone may be safely administered for longer periods if necessary. |
Annotated Indication CUIs: C0042510; C0042514; |
RXCUIs for this Label: IN=703 SCDF=377132; SCD=833532; |
Similar Labels: 01C3122F-E791-40A5-B52E-963CB6685F71;0c40521f-99e3-4546-a71b-64749c3e8c16;1EFECA40-3DF8-4B89-950C-EC8CAC6B7780;304d0be4-0c13-4dbb-8ffb-b2e7caa7fb1e;42a5ed18-0ea9-4fb0-87b7-62b3af79f85c;51772745-9ea9-42cd-97e6-7266f41ae3ca;9fd7a181-ab26-4e68-8404-20ce339b0844;FE8909BF-9106-43D7-B89E-1DC4874CB864;b7e2af06-1fe4-4b45-ae5d-bc6279ca47f3;cdd50dc7-f712-4248-b0e3-ba247cf08cee;d45418b5-ba22-40b0-e29f-842d11bb09ae;d8d04647-8e25-4127-8ecf-360ce1991c2f;e9108958-b8d7-4fba-87c3-9a32990de551;f446e1b0-2c46-4763-8eb0-b3a6be956f69;fcc8658c-761a-443f-8c32-1499d86028ec; |
Clobetasol propionate foam, 0.05% is a super potent topical corticosteroid indicated for short term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid responsive dermatoses of the scalp, and for short term topical treatment of mild to moderate plaque type psoriasis on non scalp regions excluding the face and intertriginous areas. Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic pituitary adrenal (HPA) axis. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of clobetasol propionate foam, 0.05% therapy (See ADVERSE REACTIONS ). Use in children under 12 years of age is not recommended. |
Annotated Indication CUIs: C0406317; C0037274; |
RXCUIs for this Label: IN=2590 SCDF=379105; SCD=861353; |
Similar Labels: 11054e55-9dd4-493f-8d1b-d6da7dad7ba2;3f75880b-9ead-4c6e-b999-3bd7e1643ce5;704dcc0f-a20d-4d92-b338-cc478d5ae895;797805f2-5a08-4ed3-8057-6b0b1bb08113;8e913e0c-24c8-4e4b-9212-8d7bd6aabdb4;943d8700-e136-4c71-ac88-5fb323af95a1; |
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion hydrochloride tablets for the management of a patient s first episode of depression should be aware that the drug may cause generalized seizures in a dose dependent manner with an approximate incidence of 0.4% (4 1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4 fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS ). The efficacy of bupropion hydrochloride tablets has been established in 3 placebo controlled trials, including 2 of approximately 3 weeks duration in depressed inpatients and one of approximately 6 weeks duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III. Major Depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts. Effectiveness of bupropion hydrochloride tablets in long term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use bupropion hydrochloride tablets for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C1269683; |
RXCUIs for this Label: IN=42347 SCDF=378233; SCD=993687;993691; |
Similar Labels: 0a7eb657-e991-4243-8165-58e506180a9e;0d1715b2-4193-43d6-9a23-0469d6338ea4;14b11c03-6410-4192-95e0-2f4145509933;24e1efd1-d6b5-49e8-83a9-e9d2a4843835;28fa8921-7546-4681-89ab-9ec32695e701;424efa0f-b2e6-40fc-80be-4ea2ad267720;4d3191de-685a-45ee-bb98-ea76e0e8ab99;5f69a06c-7f8b-45ba-9820-9b58bc477640;60525754-0d2b-4ba4-918a-1c9d3eff89b2;6e636f4a-e649-426d-ae34-e599e3f9c926;725b405d-a6e5-4ad6-820f-4fdebcbfe9fe;753dc2b2-8297-4b5f-a130-e76b00f93734;753ef4af-e31b-40f0-b757-b088e5bbf1b6;85ab3b32-c02a-49db-9aa8-3b8c263dbf2c;86530199-999b-9f92-b1bc-b8515ec829f3;8e9b33e3-beb8-4970-bba5-78fbde261ce5;9251cc4c-33c5-e05c-9b8d-647855c53dbb;92f0c82c-8b9b-4bad-9de2-6e1b81588000;9ac9a12c-25a1-4547-8a79-a79f83854dc5;a6f7f0e4-87ea-4508-b899-91c8ba819ab7;bde35cdf-41e6-43be-a144-398e1928060b;c46845ee-ed1c-4788-882c-b9a84ff88bab;c6251001-4563-6b55-3043-d7cd221f4dfd;ce024abb-c5d5-45c8-bc3c-afe18b1bebe9;d06963c7-f6de-484e-a212-34d865939e8e;d705cacb-5c5e-4f6a-becb-bace1a5a0a0b;df777f28-cf31-4b73-b4ab-249479619566;e2eaf21d-0589-484e-9dba-82b3cd2299ac;f117f33d-b112-4ecc-a908-6ef3d2823294;f676f4fc-7802-49c2-89de-513343105302; |
Indication SKLICE Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. Adjunctive Measures SKLICE Lotion should be used in the context of an overall lice management program
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Annotated Indication CUIs: C0030757; |
RXCUIs for this Label: IN=6069 SCDF=1246672; SCD=1246673; |
Similar Labels: 4c5557cd-c4cf-11df-851a-0800200c9a66; |
Before instituting treatment with ceftriaxone sodium, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug resistant bacteria and maintain the effectiveness of ceftriaxone and other antibacterial drugs, ceftriaxone should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone is indicated for the treatment of the following infections when caused by susceptible organisms LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase producing strains) or Moraxella catarrhalis (including beta lactamase producing strains). NOTE In one study lower clinical cure rates were observed with a single dose of ceftriaxone compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone and the comparator. The potentially lower clinical cure rate of ceftriaxone should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES ). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,* Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase and nonpenicillinase producing strains, and pharyngeal GONORRHEA caused by nonpenicillinase producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone sodium, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with PELVIC INFLAMMATORY DISEASE and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone has also been used successfully in a limited number of cases of MENINGITIS and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli* *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS The preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone provides protection from most infections due to susceptible organisms throughout the course of the procedure. |
Annotated Indication CUIs: C0149725; C0271429; C0037278;C0042029;C0018081;C0242172;C0684256;C1112209;C0025289; C0392618;C0029443;C0157749 |
RXCUIs for this Label: IN=2193 SCDF=376593; SCD=204871;309092; |
Similar Labels: 00c96589-6998-4088-a312-ba831433ded6;03283208-8616-4117-9d2b-aa8046017a4f;0799b639-1d06-4ad4-8bcd-4922db100717;128bb292-d174-4769-b3e6-9f16617f31e3;1781fc07-5a2a-4b31-aad9-d0457eb704f4;24e1525f-a347-4745-b577-5dad60ef9f45;2b55e178-987d-4ab7-b12b-be9ab2588292;33529ede-844c-4dcf-9fc4-93962535981a;35c69667-b48d-4fda-823b-c4c05a7cc82b;365fc265-8e6c-432f-9fda-911f5f7fb451;392fc0f1-b910-4d97-9b6d-00e1b2bc9d78;3b36beb7-db94-4b07-8c81-bd2b601a6601;3c5e2c32-58ff-48da-aabe-93562868a390;471fde4e-1661-4ca0-9d3e-18522139687a;4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1;4d1ad77f-2c6b-4250-82e5-ab3574444e08;52802c0d-a617-4ba9-8f98-5a652025306c;53df951b-2eee-44b1-bae2-df7ed85bc0ed;5cf93bc5-9e4c-4734-bc02-c7d0ac071022;60bc6eab-fc04-476f-a894-d3cd56fe8f6f;67153914-16bc-490d-82d7-638061618467;6cc898bd-f6c7-4d44-b2f7-a5f9410c4d0b;750fdf6b-e2b1-4d28-a8b1-81b326c714a2;7dfb35c5-91a3-4193-94d7-ae2c5d787bc9;7ea1db43-40fa-417b-8911-ae98092070a0;8351aa37-552d-471d-b293-c564dcb6ec29;86ec0a92-a552-4a6d-9125-a54f95e43392;87859aea-e6d8-4d68-8ce3-135163a7fdd8;8828d4c9-6e71-4d0a-9ca1-bd0d231184ab;9467f6c9-3e59-45c6-a1be-77200f2d4554;9d1f630b-e759-4395-9d01-ddc90e4fea75;a0135a49-0c38-4235-908e-cf773e34dc62;ba1dfe30-7ea1-4662-8a70-add5670b1c7a;befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0;c3122a02-0a44-49f8-947f-109092c38a13;cb52fd1e-2ddf-4f45-b5c3-3d56b907270e;d4ff7c80-f38f-484e-8c95-2fb322500530;dac396fb-748d-45ea-9830-17c6eeb8834f;dc28e719-6fe0-4d9e-a624-adb76b04b299;de028434-46cf-44f6-8ac6-889c7c6943b3;e3485086-7a10-45fa-aa83-ee6fbbf39c59;e38c48f6-4d07-422b-9bb2-3c1025946e86;f5d7ae2f-5485-42e2-af2b-bd7f06df85d7; |
Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. |
Annotated Indication CUIs: C0005001; |
RXCUIs for this Label: IN=25025 SCDF=372199; SCD=310346; |
Similar Labels: 1cfbda56-d700-4049-8a51-e24af8a622c4;344a2e9e-24fa-4550-863e-ff56df0bf15c;5e2ea873-f8a4-4b19-b79f-93f957114352;7813e1fc-0081-0e69-136e-a7c7dc4ed589;87b26764-074f-40f2-8d4b-446c03bf4d68;aae33c98-7c57-49bd-9b1e-3af0b1201e08;adfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad;be37d74f-2c78-41bc-8a17-cd53d1a92d2e;c59f8018-fff8-4884-a3c8-bc306e2c8f64;c9a3cb34-9a8e-4538-ab90-32e08d8acc3a;e3469758-5111-4c30-a7fc-12444e914515; |
JANTOVEN is indicated for
Warfarin Sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. |
Annotated Indication CUIs: C0042487; C0034065; C0004238; C0027051; C0038454; C0040038; |
RXCUIs for this Label: IN=11289 SCDF=374319; SCD=855288;855296;855302;855312;855318;855324;855332;855338;855344; |
Similar Labels: 19a69a72-ac5d-45d5-a94d-a5aaecbe4730;3ebcb71e-9a7e-4969-abb9-7c7d3e3aae3c;3fb2aa58-3a40-4255-a261-e2db5b9a5dde;4445c26e-ec5c-40f4-956b-93c12fc73c1d;5907ef77-9c4d-4e3f-be7b-6157ebad2173;75f9abdf-52f2-48ee-b65b-9160c38564ec;77f258d9-f380-4815-8140-0b2bfda3099c;8ad881e0-ca41-42ad-9d7d-eb85b3a30af0;ab047628-67d0-4a64-8d77-36b054969b44;ab50f13c-7ec9-44b4-9a9f-ee3ddda6c8ea;b1b766b1-0327-48cd-ab01-e85038cf365f;ba41b963-ec4a-4421-ac93-26654876a6be;bd72a7c7-ff12-4b95-8d39-4426231bd5aa;c0f238ff-2804-4150-9766-22a5111b4e74;cd6d1b85-0ba2-4a10-a5b8-25496ae13fa3;d91934a0-902e-c26c-23ca-d5accc4151b6;e9d8fb69-a4c7-48cb-a4a9-e5d18eb4fd63;fe64cc25-d490-48b8-afa4-88cd9c3f6ee0;feaa5f6f-9753-4f37-ab81-04c9c6b45e6a; |
Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ] . Important Limitations of Use Glimepiride tablets USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=25789 SCDF=372319; SCD=199245;199246;199247; |
Similar Labels: 1a20e954-9007-43d7-b056-cbc88214951a;222b630b-7e09-43b4-9894-3d87f10add91;28eefc95-d92e-4555-b6c5-2933860b0610;3f626e54-b043-4556-9568-ace556cff9e9;9b74fbac-9e04-4927-9981-1e3dace89c6d;f035ba75-944e-45bb-95dd-e6c8df91a504; |
Benign Prostatic Hyperplasia (BPH) Doxazosin mesylate is indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin mesylate may be used in all BPH patients whether hypertensive or normotensive. In patients with Hypertension and BPH, both conditions were effectively treated with doxazosin mesylate monotherapy. Doxazosin mesylate provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin mesylate were seen in patients treated for up to 14 weeks in double blind studies and up to 2 years in open label studies. Hypertension Doxazosin mesylate is also indicated for the treatment of Hypertension. Doxazosin mesylate may be used alone or in combination with diuretics, beta adrenergic blocking agents, calcium channel blockers, or angiotensin converting enzyme inhibitors. |
Annotated Indication CUIs: C1704272; C0020538; C0600039; |
RXCUIs for this Label: IN=49276 SCDF=371961; SCD=197626; |
Similar Labels: 01d055aa-3662-482f-92f6-0b76b6633ab4;05e29a60-ebf9-470a-b565-40a6f1f6e102;096fec41-0af3-4ceb-8b72-2a86b8aeb937;0ae00cc4-9e6b-42bb-9d3c-c5d2e45fde1a;17d13f2e-6b0e-4b66-8351-6c590f79536b;3130fbe7-7cf5-4f52-8a74-099f3892b461;345478A6-8389-4229-92B3-6E40DA7B06FD;3a5f4fca-f967-4d21-ae62-a096b8d184ff;3ed04255-7d9c-464c-bfa6-c355755862d8;426f6918-7705-4988-a875-823196f43859;445e0341-5f8a-4a59-9cc5-f93177f5bf9c;4abe1804-ae5f-4401-b84c-8ca6a71fbf74;4d0c38b0-8089-45b1-613f-563176c53e43;4fa5c2f7-cda9-56cd-622f-b3d05dc7c94b;74b231df-489b-44af-8860-2b457d6103ed;AE6C88E4-C6E6-4C5F-8248-F1D01D73DAB2;a374edef-e4ef-48ba-a3f5-5f816b24d7de;b4095fd5-83cb-4789-964a-c921656b10a2;d7bb63a9-5ad7-449e-b1f2-7254370bada8;ea2a9cd6-1b03-4d96-9081-5cbc45473020;eefc47bc-c10f-49bb-8ef7-5999f798ab39;feea8d72-5781-46d5-831d-855f478c704d; |
Clobetasol propionate cream emollient is a super high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g week because of the potential for the drug to suppress the hypothalamic pituitary adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. In the treatment of moderate to severe plaque type psoriasis, clobetasol propionate cream emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use clobetasol propionate cream emollient for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS and INDICATIONS AND USAGE ). Use in pediatric patients under 16 years of age has not been studied. |
Annotated Indication CUIs: C0406317; C0037274; |
RXCUIs for this Label: IN=2590 SCDF=562031; SCD=861495; |
Similar Labels: 109b741f-624e-455c-97ff-2ad0034182df;20cf8e9a-7889-4005-b926-f41d1b055a57;218da851-af52-48e6-bfd5-2e716d0a85f0;2d4fa3a3-dc1c-4d3c-9959-4751e09d25be;38b59fd2-8d8c-45d8-bf30-55f2c668523a;39f719f6-4e44-4aff-bad1-7529bf75bda2;4a761afb-a48a-4a5a-8700-ad93601a260f;52858738-a71c-4330-a7b3-e9c6c2161e04;54eca64c-af43-48ba-bf86-bab9d8e46bb6;830a28fb-9b80-4fbb-99dc-56ec80e4e581;833fb607-f9df-491e-bf67-33370ff7a746;8cfa527c-69c5-4722-8246-c3b4ce591a5f;8d08ceaf-d1a9-4352-9046-111b5aa4e80d;91571297-03ad-441e-8ec6-f78c21fbe5e8;95e9ad40-5c53-490b-8313-7fb3541d431e;976d9c90-1800-4dac-9b92-48284b29d2b9;A188664A-8FA1-479F-9493-0DA4A6C592F7;a086ead1-b906-4198-af19-5423957c9e2a;aaba92a9-65fb-4150-aec0-9d9f721ca5a5;acecf5ab-dd5e-4046-ab47-b9ff415d4b2b;afd20e23-b7a6-46ca-bd8d-b7af9ff84201;b22a7bb3-108b-4485-a721-1ea89adac36e;b269d3ad-fbae-4ef9-8b3e-e0477ab4615a;b6b530b3-5218-4838-adee-08e477757b98;bb220bb0-8b82-4acf-87ac-9ac8c3c66d25;c74a755b-b9a2-48cb-9387-f62a37a7a926;c77ababd-a449-4e89-a9c6-b7e401120ba1;d2a1bcea-66db-4dd9-b586-7beef185a754;d4c73fb0-9675-4c41-a8bd-dd4cb2db1169;df79a35c-ce5c-452e-b81e-50a014fc94f4;f5ea346b-f507-4224-88a6-4c891c4b1ad5;fb29b17b-96af-4a78-bc91-83cf8c5c2b1d;fdfd83ee-dfb4-4c12-a74e-a0053e34e08c; |
Cilostazol Tablets USP are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance. |
Annotated Indication CUIs: C0021775; |
RXCUIs for this Label: IN=21107 SCDF=371508; SCD=242461;242462; |
Similar Labels: 1162b345-b45c-448e-a399-b3cce63ea37b;151d1497-7655-44ce-8e97-dd1cd91f686a;1eb9a361-cd8d-44b0-bf40-42b97a470ddd;24d75b58-bafb-4440-b8d7-4f4079c08b0b;26610bfe-4c3c-4c20-8b6d-b7c18cd6fe23;5f4fc5df-5077-4cad-a5dc-1b54a73904cc;8e49409b-6bb1-4b8a-8a5b-4cb1a291660e;9c72d2f4-c586-4456-80b3-cec69b7d9ee0;9dfc5f4b-3936-4607-8495-439a27433e81;9ffdb1e8-fdc8-44d4-b558-210954138b2f;ADA307F1-B6B1-4B64-A060-5C254B1948F2;a6292311-9cb2-49ff-b8bf-12e2dbd196cd;b4509afc-539b-4d7f-97d4-5e9c98c2f65a;c4597231-fec0-435d-a0c6-8c237e3d60a9;ceac1ae3-c343-28ca-c083-b748d21a15e6;efa614a9-e857-45a7-a8c3-faa6195fa1ec; |
Kionex Suspension is indicated for the treatment of hyperkalemia. |
Annotated Indication CUIs: C0020461; |
RXCUIs for this Label: IN=56512 SCDF=375287; SCD=313072; |
Similar Labels: b916f972-10be-4e14-8603-087955fa9ad7; |
Major Depressive Disorder Bupropion hydrochloride extended release tablets (XL) are indicated for the treatment of Major Depressive Disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4 week controlled trials of inpatients and in one 6 week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS ). A major depressive episode (DSM IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2 week period and represent a change from previous functioning depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo controlled trial with the sustained release formulation of bupropion (see CLINICAL TRIALS ). Nevertheless, the physician who elects to use bupropion hydrochloride extended release tablets (XL) for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient. Seasonal Affective Disorder Bupropion hydrochloride extended release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of Seasonal Affective Disorder. The efficacy of bupropion hydrochloride extended release tablets (XL) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of Major Depressive Disorder with an autumn winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria (see CLINICAL TRIALS ). Seasonal Affective Disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with Seasonal Affective Disorder may have depressive episodes during other times of the year, the diagnosis of Seasonal Affective Disorder requires that the number of seasonal episodes substantially outnumber the number of non seasonal episodes during the individual's lifetime. |
Annotated Indication CUIs: C1269683 ; C0085159;C0024517; |
RXCUIs for this Label: IN=42347 SCDF=378354; SCD=993541;993557; |
Similar Labels: 02500709-7f2c-4251-bd8c-94ab6cdadd4c;165475dd-a250-48bb-b4c8-65c189194a9b;1c230d18-4aec-4105-83cc-43e763f1a64a;1de23b24-eb8c-4d16-a929-297132bf00d2;22009d23-999c-4fa6-bfe7-21395f577236;2315d6e5-144d-4163-9711-f855c759cf8e;235952e6-f748-4408-a8e7-7d980da0e5e6;29848192-7de3-4c0d-a822-1268dcf128b0;5036aa56-e21a-4971-a399-057a77377f4c;5c5210b3-95c6-41f0-945a-3c3567b19b05;5cb7fd36-ae36-409b-af79-9c432e1cf5d9;5f36e697-5a4c-419f-882e-d2d35e829635;64d4bbee-1cc4-409e-b65a-1f2e927cf0d1;6a3c0df3-7ed1-4c69-b963-374f9baccff3;6d0a12dc-3873-4a46-a927-9e5630b569c0;76e29f61-4f1e-4426-9865-b88dea3d0bb4;7d359680-2a9e-426a-a033-6906f51af1b5;7d6bdc28-f334-47f3-8336-c3bebbf57461;82f5292b-b113-4f10-9469-04386fa8e9d4;84718f90-579a-481f-8f39-713e1ed18871;8a2b58d6-ca8e-41e1-837f-928fa46e2097;8b245b30-1ee2-4d4b-8e8e-45d084bb7b6f;8e7c87cc-0479-4aed-9376-7adbe704c9d9;90d1bade-5fc7-4a3e-8d73-99c99906f2e0;91f37277-4aa2-44e0-a1ea-f47e9144c567;96b168d7-a9f9-4b76-ac9a-edda436c0e4e;9720518e-9f70-4811-84ca-69a526d8a904;97330579-8790-c2a8-af59-fe46ce39c58a;9bfe1903-3313-44b7-a27c-fc0775426f94;9c6e2044-c040-403c-bcd6-99ca1e6bba73;9dca0aba-821e-42fd-8353-d62348c098dc;a1e768fd-c28f-4b49-822d-ccc315b4099c;a435da9d-f6e8-4ddc-897d-8cd2bf777b21;a4a56e4e-849d-4928-8d32-528080feb67e;a4d91839-eefa-44dc-8162-eb4f8bd426a2;a5ddc0dc-c176-4705-a9a0-e4ecaf1f5667;ad02c7d6-3c14-4e1e-9ec7-3cc1ede84189;b358c1f1-044c-4dd5-a8e8-ef7800315104;b4219281-d79f-45ac-86dd-82c399415032;c6785b89-6058-0807-1761-66b59416a850;c7b80939-0b2d-4dbc-b921-2081cfd5ae3e;cbc8c074-f080-4489-a5ae-207b5fadeba3;ce537247-2cf3-465a-8150-45aff92a5d00;cec41945-8d64-4793-8784-4c2b8ec37b0f;d7c0dfda-2e49-4a9e-8fbb-cc40217ccc28;dee3f124-bc24-4a37-b2eb-501a66fef064;e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a;e962fb9a-d9fb-49c5-a8b4-0b355b8f829b;e9cef726-267e-4e4f-ac12-d92a8664bf20;f2b2bbd5-720b-4871-9785-a60df6e2e00a;fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba;fddc9630-2f9a-4104-888f-3714587d4fe7; |
PULMICORT TURBUHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. PULMICORT TURBUHALER is NOT indicated for the relief of acute bronchospasm. |
Annotated Indication CUIs: C0004096; |
RXCUIs for this Label: IN=19831 SCDF=746824; SCD=966525; |
Similar Labels: 3F994C51-D9E5-450A-E4BE-EEB12D70D2A7; |
Transderm Sc p is indicated in adults for prevention of nausea and vomiting associated with motion sickness and recovery from anesthesia and surgery. The patch should be applied only to skin in the postauricular area. |
Annotated Indication CUIs: C0027497; C0042963; C0026603; |
RXCUIs for this Label: IN=9601 SCDF=378709; SCD=226552; |
Similar Labels: 4D705C57-FA98-46E0-97F3-38E1B0ADA76B; |
ZYPREXA RELPREVV is available only through a restricted distribution program [see Warnings and Precautions ( 5.2 )]. ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare facility, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV Patient Care Program. To enroll, call 1 877 772 9390. Schizophrenia ZYPREXA RELPREVV is indicated for the treatment of Schizophrenia. Efficacy was established in two clinical trials in patients with Schizophrenia one 8 week trial in adults and one maintenance trial in adults [see Clinical Studies ( 14.1 )] . |
Annotated Indication CUIs: C0036341; |
RXCUIs for this Label: IN=61381 SCDF=885864; SCD=885865; |
Similar Labels: f9a73185-88de-4d7b-b3c0-bbf231483241; |
REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when REVATIO was added to background epoprostenol therapy. Studies establishing effectiveness included predominately patients with NYHA Functional Class II III symptoms and etiologies of primary pulmonary hypertension (71%) or pulmonary hypertension associated with connective tissue disease (25%). Limitation of Use The efficacy of REVATIO has not been adequately evaluated in patients taking bosentan concurrently. |
Annotated Indication CUIs: C0152171; |
RXCUIs for this Label: IN=136411 SCDF=373871; SCD=577033; |
Similar Labels: f158fe10-d5dc-4432-b2c9-fc665401291b;f757f066-8288-4d6c-8c5e-2471007c7966; |
AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active Rheumatoid Arthritis to reduce signs and symptoms. Renal Homotransplantation AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5 year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti donor or anti B cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis AZASAN is indicated for the treatment of active Rheumatoid Arthritis (RA) to reduce signs and symptoms. Aspirin, non steroidal anti inflammatory drugs and or low dose glucocorticoids may be continued during treatment with AZASAN. The combined use of azathioprine with disease modifying anti rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of AZASAN with these agents cannot be recommended. |
Annotated Indication CUIs: C0003873; |
RXCUIs for this Label: IN=1256 SCDF=370973; SCD=359228;359229; |
Similar Labels: 040d010a-b1b2-4db7-905d-8aa7f1bab0cd;0a83e716-b688-433f-ac27-ae95132810cf;0b383e60-5353-4231-af66-b639a3b2f02c;128846a7-18c6-4bc4-b3a0-9aeed0e8b986;49212741-389f-4112-94a9-d14ea2115825;6163F0B3-031B-4552-9299-B3F735762D24;7500c65e-9680-4719-b426-90a7162352c9;82b29384-1243-4b98-82df-3708f5ce642a;9050af7a-19c6-4670-937a-9445605de995;aaa6c540-4c84-48a0-939c-cd423134fa2a;aeab212e-2f56-498d-a286-400ba360a7d2;b1b0fa3e-11c3-46d0-9537-6b372c2a1b56;ceab8e8b-d022-4d0c-a552-cc5782446248;d32704ed-df7f-4111-986d-229ae6f433af;d65bc662-2ae8-4ddb-acc8-f616e72e6140;e385894f-212b-4582-a63a-a0767fd97645; |
Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non Hodgkin s lymphomas. Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse free survival in patients with non metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor. Psoriasis Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling Psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and or after dermatologic consultation. It is important to ensure that a Psoriasis flare is not due to an undiagnosed concomitant disease affecting immune responses. Rheumatoid Arthritis including Polyarticular Course Juvenile Rheumatoid Arthritis Methotrexate is indicated in the management of selected adults with severe, active Rheumatoid Arthritis (ACR criteria), or children with active polyarticular course Juvenile Rheumatoid Arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first line therapy including full dose non steroidal anti inflammatory agents (NSAIDs). Aspirin, (NSAIDs), and or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored (see PRECAUTIONS , Drug Interactions ). Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued. |
Annotated Indication CUIs: C0349557; C0008493; C0020217; C1961102; C0023418; C0006142; C0278996; C0026948; C0079773; C0242379; C0029463; C0033860; C0003873;C0553662;C0024305; |
RXCUIs for this Label: IN=6851 SCDF=372835; SCD=311625; |
Similar Labels: 03c66d8c-186a-4923-9a32-07ab07d472ad;18705002-da4b-4562-b0d9-df3d56a16c84;271ff7a2-4904-a0ae-778e-0b5ec8e78d76;27dd39ca-207e-44db-8da1-a0689f0d6b6f;2cb70aa1-f73a-41c8-9a7f-edbcf1a06efd;4767fe9f-aa42-46cd-8101-9df7101f55e1;47bb478d-0e3e-423a-9737-1231152add1d;4a246ce7-c04e-4119-9201-23e5f90152a8;5c960719-19a3-442d-a24b-189b4760ab69;68623ad0-a395-4847-88d4-48413c1f4fcf;6c95e493-f9ec-476e-88e2-e066f197ed8e;70c09984-2b36-424f-8b27-3fd0cd4e833d;78794e3d-f293-4eeb-22ac-8f536d5947eb;8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a;9b34b1d8-d125-41a2-9f6f-3fab67b573bd;9c4a4784-b063-4c8f-b915-aeb18cb149be;A551FAC0-8738-40B3-9B03-602F794A4B66;b585f621-f6c9-4735-ab61-bd1b401f3df0;d71b1856-99d8-4a9e-9189-f87b6675f80a;d85e0fbd-89ff-4157-abe6-87ce307658be;e942f8db-510f-44d6-acb5-b822196f5e8c;ec476b11-0b3c-4139-b1eb-a3daa76bc271;f13eeab7-f376-4912-aef2-450ea027de6d; |
OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. |
Annotated Indication CUIs: C0878773; |
RXCUIs for this Label: IN=32675 SCDF=406139; SCD=403799; |
Similar Labels: a162fd5b-b2ab-4d45-8861-71b60b92acb4; |
Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylin is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate to severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. |
Annotated Indication CUIs: C0041671; C0027404; C0270611;C1263846; |
RXCUIs for this Label: IN=6901 SCDF=476365; SCD=1091152;1091322;1091389; |
Similar Labels: 09f13452-8f90-426e-9687-d30be75db9d7;330e620f-4b7f-4101-91dd-feddb7a823ed;495f0c2b-cd79-4bf3-a381-f7c2a2513366;533fc1a6-b4cf-4d73-9d41-b4fe9fe5c8af;6281ca7c-2aec-4f14-b7e4-82401a701c96;739bbd64-d9e1-4771-967b-a2cd08f4eaf5;a7713510-2a7c-4c34-9fc2-a96fcdd52891;e817377f-bc72-415a-acd2-7136746b2479;f04e8194-7077-42cf-99ee-b61e42a76cf0;f931d3af-c32a-4406-8799-9b097f41594b; |
ANDRODERM is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
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Annotated Indication CUIs: C0022735;C0403818;C0022735; |
RXCUIs for this Label: IN=10379 SCDF=385473; SCD=199116;313234; |
Similar Labels: 053a7300-0bce-11e0-9d16-0002a5d5c51b;3fa5b81e-81fd-4017-8e87-a4a4c08119fd;48f8aa83-e043-41b8-9a20-dbb098045895;6e9cbce2-6e73-400f-9333-421a42afa3ae;77215d87-ad22-4169-bd5f-a453f10b21ef;8677ba5b-8374-46cb-854c-403972e9ddf3;9f2aae1f-898d-4955-be31-678e0cf85395;ac40e05b-6e67-4ff9-a0e8-2e897e71b282;ac47efbe-025b-4688-bcd3-a10a0b012b34;c506aaa3-04f8-4eb1-8dc4-e964cdd08e7f;d466910c-9a76-44e8-8759-4717ec2c591f; |
Diovan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=69749 SCDF=374279; SCD=199850;199919; |
Similar Labels: 0DD5FD1C-AB03-4860-87D6-4A95DF6E7B7A; |
COVERA HS is indicated for the management of hypertension and angina. |
Annotated Indication CUIs: C0002962; C0020538; |
RXCUIs for this Label: IN=11170 SCDF=374290; SCD=897635;897646; |
Similar Labels: c56b20d8-eeee-4d87-94a1-ae186f9b550e; |
Treatment of Restless Legs Syndrome HORIZANT (gabapentin enacarbil) Extended Release Tablets are indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night. Management of Postherpetic Neuralgia HORIZANT ( gabapentin enacarbil ) Extended Release Tablets are indicated for the management of Postherpetic Neuralgia (PHN) in adults. |
Annotated Indication CUIs: C0035258; C0032768; |
RXCUIs for this Label: IN=25480 SCDF=1087974; SCD=1101335; |
Similar Labels: 05506250-1641-4b64-ac0c-69f96c46a773; |
Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone. |
Annotated Indication CUIs: C0278140; C0085281;C0278139; |
RXCUIs for this Label: IN=6813 SCDF=372806; SCD=864761;864769; |
Similar Labels: 092d78eb-6423-495c-bf0d-e6532bea7138;0b72a120-ca4e-4b90-7d89-52967a39adb3;20127592-3a20-e280-2c70-f3d4e1ce009f;3c926b78-999e-4d26-9498-7f1bcaf0b992;4a3b2bc3-d837-4ca9-aee1-452633b6a06b;544483e6-6f9d-4371-9e93-313e54e0ea05;5E70E915-B946-4A80-BCC6-3F49BC30F2F5;7ff89589-149c-4007-8144-5f60131b8c33;8C363F90-C378-48AE-ABBC-AEB25C9BF5CB;9bbe219f-3bf1-44f4-a709-cd108c4fa9ef;C54BAAEE-8EA4-45F5-A5C8-BB84CF86832F;DA0A54C6-8B53-4774-8C40-E615AC8D804D;a36705c4-867f-41f1-94c9-78b8b31836ce;cf10ec82-1f41-45c0-b438-5ade38b5625a;d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb;ec41ab86-a948-44e4-b21c-c65a22cdf294;ec694185-fcb9-49d9-aaf5-e88861346c7c;f2057290-4286-4581-9711-50a0a834e228; |
Felodipine extended release tablets are indicated for the treatment of hypertension. Felodipine extended release tablets may be used alone or concomitantly with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=4316 SCDF=439558; SCD=402695;402696;402698; |
Similar Labels: 2aad9cdf-6431-4661-5cb4-f69e735f47e4;2e4298cf-02e9-49c7-9803-887161e1989a;33de7317-dbe6-4660-9d7e-2babc9c9f657;4bfc1982-6fe6-4d6d-99f2-f2d1cd708540;4c5e4905-ddc6-4579-aea0-994d03dd52b3;60fb803e-ccf7-46f2-b506-e157ce440f87;71dde844-9dd0-406c-943e-9995a28c43c7;aac77fa1-04ad-497e-bbed-a21f538064c3;b4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c;b951455c-c235-4e23-9e21-08672d108726;f94ae052-5d59-4750-aab7-1fdb989503aa; |
To reduce the development of drug resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae . Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis . Psittacosis (ornithosis) caused by Chlamydia psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis . Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis . Nongonococcal urethritis caused by Ureaplasma urealyticum . Relapsing fever due to Borrelia recurrentis . Doxycycline is also indicated for the treatment of infections caused by the following gram negative microorganisms Chancroid caused by Haemophilus ducreyi . Plague due to Yersinia pestis (formerly Pasteurella pestis ). Tularemia due to Francisella tularensis (formerly Pasteurella tularensis ). Cholera caused by Vibrio cholerae (formerly Vibrio comma ). Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus ). Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis . Granuloma inguinale caused by Calymmatobacterium granulomatis . Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug Escherichia coli Enterobacter aerogenes (formerly Aerobacter aerogenes ) Shigella species Acinetobacter species (formerly Mima species and Herellea species) Respiratory tract infections caused by Haemophilus influenzae . Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae ). Skin and skin structure infections caused by Staphylococcus aureus . Anthrax due to Bacillus anthracis , including inhalational anthrax (post exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . Syphilis caused by Treponema pallidum . Yaws caused by Treponema pertenue . Listeriosis due to Listeria monocytogenes . Vincent's infection caused by Fusobacterium fusiforme . Actinomycosis caused by Actinomyces israelii . Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. |
Annotated Indication CUIs: C0001261;C0003175;C0004771;C0006309;C0006818;C0007947;C0008354;C0018190;C0023860;C0024286;C0311389;C0032064;C0029291;C0034362;C0035021;C0035243;C0035793;C0039128;C0040592;C0041351;C0041912;C0017575;C0043388;C0001144;C0152499;C0009770;C0018081;C0155866;C0035597;C0241893;C0041471;C0042029;C0037278; |
RXCUIs for this Label: IN=3640 SCDF=371966; SCD=197633;310029;359465;597808; |
Similar Labels: 08c07b97-137a-437f-b6c8-f83e301ef030;091c71be-dd6c-4f7a-9af0-3222686345a5;0c01acd6-123b-43f3-b639-b039e83baa27;0f342e3a-189f-41ec-9583-1733d2437ad2;120b912d-87d4-4463-ae46-5e48ca33db49;1292FA83-E2A1-4FDA-B0DD-CCF763265FE1;14300ca2-d99d-40c6-a771-2aeceb344dce;15d40152-f9f5-4ca0-ae93-a57911baadf1;19b19a55-972c-47c1-b031-cad69c624fa1;205c4672-2006-4999-9897-33079fefa3a1;214a9cfe-a522-4022-81d4-e59f447401fe;2342cfb7-6ac2-471e-8b69-44d4e9bfe765;2a3b79e8-f14c-4b44-9d3e-3c92a82269bd;2bcde264-5f6f-47f6-ae2e-1b7010deacf7;33C9CD03-A005-476A-9A57-50BFE913674A;34878e92-c843-4cce-812e-a82cbb96df2b;369cc496-f093-4745-b4dc-c38ef0b9da5c;37045a6a-defa-4041-9bc1-18784f49e3f1;37efefc3-cc45-49d1-9dfd-c47d6e6becd5;3d9aa97a-665a-44d4-990f-3d1a54c04174;407d9920-7110-4299-b0fa-36661070f076;41fd9969-059c-47a6-a424-4382804407c0;422811d6-915c-41a5-be70-212e65d6f647;426a574a-a832-4723-beb1-4e869b6539af;495c671e-6eba-4c9b-a5b2-229520a77d68;4999bbd9-44ed-4749-9730-be2337bdf490;4ae0ff63-c577-478e-9fa0-b7c22a8e7de4;4c6791a0-e7ef-4645-a460-8f9a13f3d166;4d0ba36c-0a4a-4faf-9f1d-79e5273808d5;4ec4c8ca-ce83-4948-8626-21eb82ae5c19;500be4f9-1ce7-4a40-b6b1-d0b12f0856dd;53eb28f5-41c5-4470-8878-1c5085c27166;5878bfaf-66b2-4a78-b6b0-f6405d44ebef;5fbef611-39db-4a8e-8f46-090c95a27042;60e29e4c-7512-4aba-95a9-be987129ad63;6adc5bb0-69a5-4c9f-b569-1eee446afcd2;706e50a5-1998-46ab-a635-402fc5489865;78f1e08f-0a80-4ab0-a39a-640ecf775620;7e29a5ba-57d1-46c5-a93f-ba6b3d6b3327;8224b9c5-5c4b-4dda-bc58-47b6604c2884;829dbd3d-5c2b-47b8-96a5-423af78c93b9;86e1102c-47bc-4f27-a4d0-7261b3deba63;87fce959-ba71-46b8-911d-2004658196ce;96424d21-3fa4-4a32-8b98-fd593748f236;9a3ab62e-97c0-49fa-87ea-f33214f2ea5a;9b52e0a7-f024-4d8a-a59e-374946e60b44;9d9f5a4d-e3d2-4adb-bce0-ed2aab9a368e;9f6c6dff-befc-4e1c-8a62-7c783c23fb3a;a121fa30-2aaf-4dde-a08e-a67381333751;a569ba80-ffea-40b2-9fbe-a42810b1fccb;a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2;b34eb07b-d8a7-4762-a457-9d64dd86b205;b3fa8d62-cec4-416b-b979-56a945423ae1;b5952252-875f-479c-8864-89f18c974fb1;bf667704-f439-4e8a-a4a5-dd150462a125;c4aae81f-0219-450f-aa60-953964f74172;c6d4e685-d1b3-4e81-b6f5-47db218ed117;c84c9328-b364-467c-84e1-d87af1cd1887;c96d3986-9d92-4ec4-a319-a50aeb2f4fe7;cabbc39d-0fb6-4d0e-8966-7e60f02cc3c7;cfb4ae70-0bd4-4585-bbaf-507b18437866;d583b8b9-e5c7-45d6-8fc1-d51f51a16181;d6f98d3c-5a20-4cbf-9a9c-abef10b9e465;d95bdf63-69a2-47b9-b909-97c74b6d7731;e358437f-7c6b-4e49-957d-d7f5b8f4b8f5;e563fe71-0316-4caf-9b50-59e2c5e2596e;ef019728-72a2-4152-97e9-471053776837;f9b9ca8a-5cfc-446a-8330-36cf96625a57;fac9b9c0-7ea2-4986-9552-dc46a32b7c99;fafe6400-b7c9-485c-b76e-0b85b29db801;fef7f0c9-48a1-46b4-a19c-c23d272a8ca2; |
Desipramine hydrochloride tablets, USP are indicated for the treatment of depression. |
Annotated Indication CUIs: C0011570; |
RXCUIs for this Label: IN=3247 SCDF=371709; SCD=1099288;1099292;1099296;1099300;1099304;1099316; |
Similar Labels: 3433c754-cc2e-4e72-bd82-16ed4af3144d;711d8455-9ce1-45b4-875d-007b2e0b27ec;7500ac1b-a1ca-46ed-8f4e-5998310c676e;7ec5f73f-32b6-48c3-b16e-891d06edf6eb;a8450022-7caf-489e-a6c7-2415fd092032;ba02a95d-d82e-4a13-90b4-a219abc0249a;be70fddf-644a-44ad-bfdf-0914dd12b1af;c7cdd04c-6c34-4780-8b21-a6f9fc74cf46;f3127fff-2943-424d-8b8b-80aa320a2d07; |
METROGEL is indicated for the topical treatment of inflammatory lesions of rosacea. |
Annotated Indication CUIs: C0035854; |
RXCUIs for this Label: IN=6922 SCDF=378013; SCD=577237; |
Similar Labels: 2b2a552d-ea3c-472c-bf61-f4d878cc4874;ab3a8a2d-714a-4beb-af8a-99bc3ac3ebbe; |
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY lactamase negative) strains of the designated microorganisms in the conditions listed below Infections of the ear, nose, and throat due to Streptococcus spp. ( and hemolytic strains only), pneumoniae , Staphylococcus spp., or influenzae. Infections of the genitourinary tract due to coli, P. mirabilis, or faecalis. Infections of the skin and skin structure due to Streptococcus spp. ( and hemolytic strains only), Staphylococcus spp., or coli. Infections of the lower respiratory tract due to Streptococcus spp. ( and hemolytic strains only), S . pneumoniae, Staphylococcus spp., or influenzae . Gonorrhea, acute uncomplicated (ano genital and urethral infections) due to gonorrhoeae (males and females). pylori eradication to reduce the risk of duodenal ulcer recurrence Triple Therapy Amoxicillin clarithromycin lansoprazole Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate pylori. Eradication of pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION .) Dual Therapy Amoxicillin lansoprazole Amoxicillin, in combination with lansoprazole delayed release capsules as dual therapy, is indicated for the treatment of patients with pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY .) Eradication of pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION .) To reduce the development of drug resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension and other antibacterial drugs, amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed. |
Annotated Indication CUIs: C1279247;C0699744;C0555970;C0031350;C0018081;C0149725;C0037278;C0013295; |
RXCUIs for this Label: IN=723 SCDF=370576;370577;370578;370579; SCD=308177;308181;308182;308188;308189;308191;308192;308194;313850;598025; |
Similar Labels: 01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa;015f1664-8b4c-4cb6-8a01-aba440f2b452;09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd;0dbb3a86-a601-4d40-ab44-01901660181a;13bd4214-9b7f-425b-af5f-fc1ddc678230;1d480bbc-9716-427e-a558-e6dd48a90edf;20c86622-85b7-4827-a317-57aee79dfe57;269fa5f9-974e-4cea-8f6b-a2913a6dc1cb;2b55a812-a862-4f35-a6ce-25cff716e63d;2d526d15-6014-4389-8dc9-20ea8e512cc2;31c12a11-7bce-4457-b413-feaad0da9c49;3599277f-1f6e-43f0-9e09-0ec2ec5a0df1;3ac57b9d-0b78-485b-acbd-4b1f9328204a;3afc3097-a757-49a0-aaec-85ac267aabb1;3cacd754-73f4-496e-a529-9ca39fa6692d;3e1df272-caf6-4247-8ccf-4e37bfe67e0a;432287dc-6d16-4a64-bc5f-ec1327104f7e;4ba96ba5-7e7c-4225-981f-593964c61a0c;4c0f348a-a65d-409c-8668-207c82a5e3cb;4d68df6a-6e96-47a4-abeb-6afc7cc84bbc;4fb7837e-964c-4d38-a3a5-b384b1bd6e08;520b05ef-420e-47d5-9491-63a7ba9e5423;5d22f9b8-3022-42e8-a427-fc43c589c92c;610ead3d-a415-4762-8c3c-91c87665f138;6136dcbf-9bde-4b5b-82b3-d7cb8bdb817b;649d285c-8fcb-48dd-aa5e-2f34128102f5;6dcd320a-2ba4-4dad-8173-1cef72b4c816;70e213e7-473a-464c-8e58-26bf921d5c40;768ba0a1-7b08-4b16-8083-b314168650b8;78cabf7c-f342-4285-bc5a-9f24789d44ed;79a0421c-eeaf-40fd-a3b5-fd7d941ae530;7e3a4517-1934-4e03-b96b-4ad65ab076c5;843f6053-63d9-47d2-81f1-b6aa78a7c20c;878f5bb7-1fda-4ac9-8190-c7e5571993e2;8865ccfb-6ab7-45f2-807f-11c9aa681836;88e76bdd-39f2-48c4-91ca-609511afd382;8d53dc31-a51f-4326-a6cd-5aa6aebda3ed;8da47758-aa37-4eed-bd37-8a48914c21cf;9327ca14-edb1-4542-89a4-377a790de06d;98e9274c-c02e-44d9-8cc5-17536ef03a77;99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e;9963c7b5-e2f5-40d8-b976-61fb453d17f3;9a8cd40a-6fb6-46b6-b692-da8669097e02;9ea9486c-822a-a38b-7eed-8d3740ee502b;a06f4905-2c1b-42ae-9c47-5d95e532c2a2;a0f5c480-7ada-4593-83c4-4cf15eaabd7d;afbcbf79-e7cd-4615-a999-9941573882b5;b03d1cc5-6142-474b-9670-a364393d4142;b18eca1d-0133-4266-829b-9a0bd925c4f2;b23637eb-16ff-4e92-96e5-d6efd5cc4ee8;b41ecd6b-4c54-44c8-aa3f-1868faad07c6;b44a012a-d4d3-4383-8770-ce37367704ee;be65d31a-87c1-4f37-a55d-7395bfe3642a;c48c8351-ee27-47c6-a88b-c642c6baf5e1;c5774511-bee9-4ebb-a9aa-9e74de8d840e;cdad645a-c939-496e-973c-d1a22ffe6b29;d42fbeff-dcca-447c-83e2-c59690b7dc1a;d46f1091-33dc-4f8f-9c34-75dcfedb4b4c;daa89601-3e7c-4d9e-9bed-fd6abf20348e;de8990a6-f3b6-478f-acbe-eda961b6da4b;e4e9a872-2bda-4e9e-9803-eb4782489978;e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d;ee3875c6-5c49-4386-8ad2-5fe3208ed9e9;ef7e6645-e771-4441-8bc4-07547cf30e22;f0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b;f180e621-7bc1-4581-b34f-04c38a47d219;f1bf6b2f-d00a-4c3c-a55c-46bb0ad6d5c6;f27aa99b-2b77-48d6-8af4-3ae26c04d5b6;f884225c-7845-4df1-ba35-dc53010ed0b0; |
Parkinson's Disease Ropinirole Hydrochloride Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of Ropinirole Hydrochloride Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L dopa therapy as well as in patients with advanced disease on concomitant L dopa (see CLINICAL PHARMACOLOGY Clinical Trials ). Restless Legs Syndrome Ropinirole Hydrochloride Tablets are indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate to severe RLS. |
Annotated Indication CUIs: C0035258;C0030567; |
RXCUIs for this Label: IN=72302 SCDF=373800; SCD=283858;312845;312846;312847;312849;314208;562704; |
Similar Labels: 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0;1669653f-d7bd-453b-8d56-997a637f913a;1c1b2587-3d65-4d21-b913-9a3918435b8e;1cb783ed-5496-4b4d-995b-e81157f9f8d1;414cd6c4-4926-4dfc-93c4-f04f4b7eeac3;5525c364-3574-4029-89dc-1efc6d85c03c;6f7fc849-8a38-47a1-bc39-54801a86416c;7734ef0b-584f-42dd-a8b5-adbdf4e4df93;85971b31-6f7d-421c-bf3c-5b33f3c1e781;88c5b939-a658-4972-b849-e5c00a447b53;9682167e-7f40-40c5-95c2-dccb054f826f;9a8eb66e-21fe-468d-aeec-44a8aa4c7869;a543b4fb-186a-40f4-8c88-861b7db2b3e9;bee2269a-22e8-413f-99bb-ea64169b4491;c3b91380-1a23-4b44-bd1d-4888e43fe8b9;cd4d1aeb-debf-458a-83c1-fa098d4d3415;d52d231b-f407-f6a0-466e-0f714244010d;de0bb94f-4fd8-4f27-5ba6-6f392dd5160f;e05b026c-c46f-473a-b23c-56b463f95df1;f1b2850e-097b-4a59-9c65-7cde77f30894;f5ce07b9-ad0d-4b72-9daf-8662775af093; |
Nifediac CC extended release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=7417 SCDF=373070; SCD=198034; |
Similar Labels: 19592ac2-e193-47c4-b93e-e1d124d005d6;1e80b790-a57e-46ee-a257-4f59ca6502ce;35e4dff3-f430-4761-b8ff-5875c52495cd;409af9d8-67ee-4532-903f-a7bd5ad3d2e2;61f55d0f-247d-4b12-9075-f11b9250ed5e;674d17c2-1fd4-4e14-892f-d88091b2b6d7;6c587586-b966-49a8-913b-7fafbca2127a;6fafbe75-fcae-4afd-9745-02e641cefb31;75f6811d-0906-4ed4-8619-eb3eed103d9b;983bd055-d289-4fb1-a69c-5a7f178a07d1;ad65c43d-91c7-4c7c-b16f-5025c764cad6;adaa3246-d0fc-417c-9a16-81d76f153903;b95cd483-64ca-4840-948d-eaf1e13e58b2;f3b11f4f-936b-4b75-9cb5-9ef14ee95144;fa952140-c9f6-472d-a04f-96c44fe9bca8; |
Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in two placebo controlled studies in patients meeting DSM IV criteria for ADHD [ see Clinical Studies (14) ]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM IV) implies the presence of hyperactive impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; on the go ; excessive talking; blurting answers; can t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM IV characteristics. Need for Comprehensive Treatment Program Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician s assessment of the chronicity and severity of the child s symptoms. Long Term Use The effectiveness of Focalin XR for long term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Focalin XR for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient [ see Dosage a nd Administration (2.3) ]. |
Annotated Indication CUIs: C1263846; |
RXCUIs for this Label: IN=352372 SCDF=577227; SCD=899461; |
Similar Labels: 00f1d83e-93cc-4bbe-9c3b-c488062271ab;1a1da905-42a0-4748-9c39-67eca45deccc;bdb43b40-d34d-47f0-b522-a0ad2d2b1185; |
Azithromycin tablets are indicated for the treatment of patients with mild to moderate infections (pneumonia see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae. Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. Azithromycin, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time to treat non gonococcal Urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually transmitted Urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow up tests for these diseases should be initiated if infection is confirmed. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. To reduce the development of drug resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Pediatric Patients (See PRECAUTIONS Pediatric Use and CLINICAL STUDIES IN PEDIATRIC PATIENTS ). Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION ). Community acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION ). NOTE Azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following
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Annotated Indication CUIs: C0694549;C0032285;C0275556;C0271429;C0019247;C0031350;C0311389;C0007860;C0007947;C0024117;C0040425;C0037278; |
RXCUIs for this Label: IN=18631 SCDF=370976; SCD=248656;308460; |
Similar Labels: 035002de-abec-4da4-8010-c42d186c04a2;035ce971-cf46-40c0-9b2f-ae52ab4e3468;13cbc9d9-4e59-4731-b9ef-41084859fecf;14191b8c-6048-4c6e-880f-39068a77770d;1a252370-5a2d-4558-9c5d-aa591efb089d;1daf9566-168f-4e05-b23e-fdcb09183171;1e505c90-79e4-4267-83c4-2fbb93d75cc6;24ea9765-6d74-4681-8110-5a6fc0b04db5;284f1e3c-45e4-40fc-a56a-bfacec331016;32ae8f5a-ea78-4e64-a58a-856ed8cf4f78;38bf22b9-59d5-4a05-b517-24e48a61d1cc;3b631aa1-2d46-40bc-a614-d698301ea4f9;447aaf48-3bea-4047-8032-a3c878576093;4a13b574-ff5e-417e-bef4-279fcc3d5280;51835dc6-68c7-44b0-980c-f9b38b8d7203;53e2801a-323d-448e-8278-92d672904b0f;54ba24c0-11dd-4392-8f0f-0160d6373b85;5673a9ed-58f2-464c-b2e9-6dc46077cb69;57160dd7-1f61-42de-9e87-ded819bb6bdb;58b72e4c-f419-4a70-b894-93a5804d9993;5a96f4e1-6b80-42a2-8d85-95a1ff892099;5aa85ecb-aff6-4dd7-a764-a9ba94f1e02d;5f63c0cf-b688-412a-8b0a-7c9ae9cf52ce;61c43eb6-c29f-4572-8897-954636a760a1;6307a49b-753a-4232-a51d-bf6d0537b05b;65D8ADAA-04C8-4C5E-AE57-2FBAE0979178;679af699-714d-a3a3-674b-fc9ae4474a9a;6fadde9e-dab3-4d01-b3fb-795eef7eff2f;782c1bb9-75c4-4258-97b6-fd776ca970f5;7bb07118-4b39-4b0b-914a-a4675f732c11;7bc7f987-ec1b-4b31-addc-9ff8d2a428ff;7c960f3a-829f-452f-8206-ff9a72c01468;84629614-e14c-47c9-b642-c6aa8b431929;85ff97e4-f161-4570-aa75-4b0dc4076e8f;86071c7f-9f11-4783-9492-22beb55682e6;8f0b9785-1b5c-41f0-a6f2-80088aab18b1;8fe7a7f5-289d-4546-8d08-33dd0664c5f6;918925cc-8da9-4016-998c-c06ed4676ae4;966c8f58-fde1-4af0-964b-c0bddbb05b36;9e5bb949-c9be-48cd-b0a2-6b7fd536e777;a7bf9202-9590-49c8-bde1-78517e60850f;ace05c47-3ed1-4b78-8d1c-279d1329fe3a;b69917c0-95d5-4b29-b0e3-07054a4fd79f;b749df83-49b0-433e-8a62-589a048dd716;c225d9ad-e119-4059-b76e-9a272979eb9a;c61229e8-75cb-4776-9883-c5630bc38a32;c9bb38a9-b637-4146-b66e-54b5a0862316;ccf371e5-268c-4a89-a39b-4ca25e5035fc;d0a35bcc-32c8-476e-94ff-a42c230cc7de;d2f4907f-b952-403b-229e-cc5b8327a773;d470695c-c0d7-4361-8783-45f58a932ac4;da7761ce-f58e-64e0-91b4-4eb375829b31;db52b91e-79f7-4cc1-9564-f2eee8e31c45;dd39f0d3-62f7-c081-c21e-26b521d77084;e135bf9d-b8f1-49e1-9b43-afdcd2b9c8f0;e8aae11c-7baa-443c-9db7-fca6694b4988;ee77db05-991c-4467-a299-5e79554c7f5d;efdef52a-ccc9-4612-bd91-ff5ca55a8193;f5b6daad-b5a9-462d-8e10-db22a7af1c72;f6a52c0b-45db-422e-8c22-e867a11b4439;fb5cf9d5-afe9-4d74-a60c-17b38d9b084c;fe9a82be-dbf0-b51e-055e-139c35b00898; |
Doxepin is recommended for the treatment of
Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age. |
Annotated Indication CUIs: C0011570;C0001973;C0003469;C0011574;C0027932;C0011581;C0005586; |
RXCUIs for this Label: IN=3638 SCDF=371962; SCD=1000048; |
Similar Labels: 0a25f89b-4e92-43a8-9a06-ef8c2e559442;137a953b-3c48-405f-86a6-ff778cb7f5f2;1533343b-f1ed-4c3a-bb36-23a748452b05;1edc1fca-9ac7-4adf-b894-bf8ca392ce4d;1ede17e6-19e9-455c-ad16-8029a590735c;24dd378e-0ef9-4ef8-8032-f81c1d87b3b8;481e2766-32bb-48b9-b0e4-ffccbb3297bb;4e9b122b-eddf-42d3-aeae-bee38badb2d5;54ad0284-c32d-4904-ae9a-5384ee53b2d8;6b769b58-daa9-4e5b-b416-381a5e7b167b;71cff7cd-0410-4194-9cdd-af404a869edd;7d745d52-ed8b-43cb-a672-aba1e0938ae8;87865653-2874-43e5-82c5-dea2f9bbbd6e;9ad86cfb-e91d-4e25-8bbc-fae3891c76d8;AA69C63C-CED6-4676-A16B-554F1AF7D210;b5dbe26d-4272-48c3-932c-0060d205b1de;c97a2f91-fe58-4d78-afc2-1a4ceb1f9344;ee103e51-e6be-c112-65c4-e93708bebf82;fa31c1a5-91ed-4726-ab58-fbe98056fe5e; |
Adult Patients Ketorolac tromethamine is indicated for the short term ( 5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM ketorolac tromethamine, and the oral dosage form is to be used only as continuation treatment, if necessary. Combined use of IV IM and the oral dosage form is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION , and ADVERSE REACTIONS ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. Pediatric Patients The safety and effectiveness of single doses of ketorolac tromethamine injection have been established in pediatric patients between the ages of 2 and 16 years. Ketorolac tromethamine as a single injectable dose, has been shown to be effective in the management of moderately severe acute pain that requires analgesia at the opioid level, usually in the postoperative setting. There is limited data available to support the use of multiple doses of ketorolac tromethamine injection in pediatric patients. Safety and effectiveness have not been established in pediatric patients below the age of 2 years. Use of ketorolac tromethamine injection in pediatric patients is supported by evidence from adequate and well controlled studies of ketorolac tromethamine injection in adults with additional pharmacokinetic, efficacy and safety data on its use in pediatric patients available in the published literature (see CLINICAL PHARMACOLOGY Clinical Studies, WARNINGS , and PRECAUTIONS ). Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine and narcotics should not be administered in the same syringe (see DOSAGE AND ADMINISTRATION Pharmaceutical Information for Ketorolac Tromethamine Injection). |
Annotated Indication CUIs: C1135120;C0278140; |
RXCUIs for this Label: IN=35827 SCDF=727596; SCD=860113;860114;860115; |
Similar Labels: 0772d6cb-0007-47c1-b3c9-28a1dc71b454;0baa018b-b653-4313-818d-3b0d726df492;153d3376-4e38-4f5e-8bf7-4b77bcbb2ebe;16399285-31cf-4ae2-b28e-76abf961e6e1;1a5ce8d6-92d6-4f78-80b4-cf9a11e147ed;2837a082-3a34-6f81-5e43-45a70295686b;31da4540-1589-492c-8be6-382179e8ece2;36087b99-a193-4dee-a103-8739484f4591;3d5a25e6-a117-47fd-b23e-d67597552c0f;42e7d810-ab12-4487-5082-b2a050e75e61;463cb005-7ba6-4f8c-835d-ba8f1714a6e1;499fc2bc-3311-4caa-288a-327d40eb26d9;4f49a276-a199-4f98-afaf-10a3eca91923;63b51e87-a223-4d62-b94e-60adf4872376;688f5dec-a6db-43c6-a1f8-5df99d08d395;6d0bc721-390c-4475-9915-d3bcccc60b76;7dad59b7-0ae1-4750-9122-9ab103db4bf0;86142f73-00fc-48d6-8383-3c28bd0b5832;8accbb78-fc64-45d5-69b0-35c23a1d2a2e;9a6df709-e016-44e1-8e1d-dea46689c3c8;C0336606-7366-41CE-9CEF-AA6524B92B11;a036819d-d0d8-4d95-93c9-d362d943ec2d;a41b9710-a1ec-41be-8417-b03c5d802ae2;b4b2ee9a-f59d-4c2f-878c-04a870e2a369;b701aef5-3f70-4bc2-abe7-7047b6a6e2a5;cff1fed3-1f30-4da9-93b4-8eebd0fd88b3;dce94664-7e3d-4592-86ac-2a94231e484b;dd489c86-08c0-4457-86f3-c4f36a70276c;e61ae711-e6d2-44e4-b7d7-943a9d06f985;e8593016-2bec-4c62-a10f-e7e944c26755;f713500a-20b8-8e20-c4cc-956805170335; |
Testosterone cypionate injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
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Annotated Indication CUIs: C0022735;C0403818; |
RXCUIs for this Label: IN=10379 SCDF=374050; SCD=835829;835840; |
Similar Labels: 108facca-c6d2-48fa-ba48-667c9498c61b;3201acf4-101d-4273-b4e7-2512e755b56d;4195516a-c8e6-457c-b805-43c9a3ca8b77;837570cb-8a33-4129-ad41-bead378d9987;96f8439e-516e-4b50-84f0-68984c833245;a34023dc-fc54-4f66-bab0-9596502c23a3;a38f852b-e260-42c9-a37a-e07c97a01c42;cfbb53d4-b868-4a28-8436-f9112eb01c39;f60c5520-b336-44a2-95d5-f274939fa595; |
Gemfibrozil tablets are indicated as adjunctive therapy to diet for
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. |
Annotated Indication CUIs: C0010068;C0020480;C0020473;C0030305;C2585575; |
RXCUIs for this Label: IN=4719 SCDF=372300; SCD=310459; |
Similar Labels: 0ce067fa-abeb-41a3-9bbe-7956f9a96278;16a775ec-47e7-491f-8c48-319ce43dcd3b;1c8945d1-2292-4c31-8ba4-19bece8cec8d;22ea8379-50aa-4550-98f0-708d6da97e79;2911a53a-3f37-4c4b-b424-a6d98e41aab7;317d8d2c-c347-4dec-9e20-bc6dbb1cbcde;3357b98b-fb76-4993-a655-5e307d315d41;34620a46-49ba-4593-960e-a8ec41721a20;3c40a933-527d-49e8-81ce-631e9c646000;3dae4466-86f8-4133-84c1-cba8e237ae28;3e286434-895a-41c4-8f7c-9ade565227cf;43086a47-1aba-44f2-656e-18cfd15e6021;5c09fe54-697e-4cd5-9a26-7c9c7fa9a864;694abc50-a512-423f-9bf0-f8d9ac99f030;75269c5c-8b6f-4496-9a93-1eba4208e1f7;75cac02c-56e3-4dfe-b1e2-4ce166b28833;76185935-589d-41ba-a96c-3739eefd6b7a;7632214b-7d22-4edb-af0f-bf9609d371b4;78ec73e1-6420-467f-8496-042d8d9a1d0b;7e877a90-e00f-45b2-a8e9-a9f70dfa8927;9150afcf-6e63-49b9-9daa-64b8ae65fee4;9fa2de4d-a921-48c1-a0b8-48bb579862a1;A1DA5A84-7529-4F62-867F-808A6CAB40B8;ade1420f-ccd4-4fef-b105-a0fbfbe9a53b;b57eeb99-679e-4136-80f4-85421e21400b;beade464-5f49-42c8-8373-a1406ccbacd7;c1608dac-9f44-4cf8-83d5-f8ef0c7839b6;c45cdbdb-414f-4bbf-a643-3a3d9de63a6b;c48855b7-215e-453b-b3b1-a0f9dee7221f;d709812f-e958-4065-a447-c2c00ddd7677;d8ec3de8-7f83-4c29-87cb-3f3ffc2689b8;e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd;ee012874-1a59-4803-bb72-a9a133218ce7;f4179a86-7f9c-4bbd-b10d-3507c8327dc9;fb2df26c-60c6-4aef-986d-242364489717;fdcee21a-097d-4354-bc91-e92cfdffac62;fe33138d-03ef-443d-9a78-783d4669eda8; |
Major Depressive Disorder Escitalopram tablets USP is indicated for the acute and maintenance treatment of Major Depressive Disorder in adults [ see Clinical Studies ( 14.1 ) ]. Information related to usage of e scitalopram in adolescents is approved for Forest Laboratories, Inc.'s Escitalopram Oxalate Tablets and Oral Solution. However, due to Forest Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that adolescent usage information. A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms depressed mood, loss of interest in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Generalized Anxiety Disorder Escitalopram is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies ( 14.2 ) ]. Generalized Anxiety Disorder (DSM IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance. |
Annotated Indication CUIs: C0270549;C1269683; |
RXCUIs for this Label: IN=321988 SCDF=378695; SCD=349332; |
Similar Labels: 13bb8267-1cab-43e5-acae-55a4d957630a;23ff2d62-b5ff-4837-8b54-439a65609d90;2a33f95e-4245-4437-86a9-fcfc87e26edb;3750b79d-8dac-46c1-82d1-cfe9bcac6a86;38ca3165-cd85-40b0-bf2e-57110585332e;4a08b6cf-7ba0-54a9-14e0-a6e8d1e4854e;5d28721d-097f-400e-8690-d133c76e07be;61f27814-bc32-4de5-b12a-29fe1ee9771e;9a6c8116-396d-413b-b8e7-5eb321781bd5;abb3d9a1-c528-b446-68e0-77be2cd93821;b40ad7ec-1779-450a-8a04-b5e54b6a7494;b49f45d7-432f-4529-b382-3a65f7643e2d;b813427b-dd6a-4aec-900a-ed26f9fcee61;ba60c357-8e61-4a3d-b1dc-25602dbbfc2a;c871d3fe-5ca2-410c-976d-9ec4b72c878f;cd65aa65-94d0-4e88-8af3-20f692432644;d3fba206-e9ee-4fe5-b3cb-cabc4bcead58;e2fc3b79-3424-43e3-99c7-7ac5017b0b70; |
Vancomycin hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin resistant (beta lactam resistant) staphylococci. It is indicated for penicillin allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis. It s effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin, and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or bovis . For endocarditis caused by enterococci (e.g., faecalis ), vancomycin hydrochloride has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride has been used successfully in combination with either rifampin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin hydrochloride. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic associated pseudomembranous colitis produced by difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin hydrochloride is not effective by the oral route for other types of infection. To reduce the development of drug resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0029443;C0036690;C0014118;C0149725;C0340359;C1257843;C0037278;C0520767;C0038157;C0038160; |
RXCUIs for this Label: IN=11124 SCDF=375983; SCD=313572; |
Similar Labels: 0dc0459b-3d5c-45a8-85d4-ad4927b683ee;1494d2fe-3818-45e1-adb1-adb5acc26e69;1e46fd1c-cb3c-4160-80bb-ed37a5cd7483;2fd9de3f-a95f-451c-a687-d2e1306e53bf;37592c56-6679-48f4-169f-3a00c2ab114e;622b9406-1c06-4323-8ca2-873cb9112dd4;6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168;73ce6c76-7636-49e3-a912-02d56353e009;91c050cf-3b2d-48bc-7297-e8dc68225e5a;99e523d8-9bde-43cb-8434-497015e5dcbd;a03e74b0-047f-4c55-8cdb-5296bf3ebfda;b51bb864-da6a-40df-8940-ec4ded792e89;cad65674-4e33-460c-b861-d96f2550ecdd;d9303631-4301-4704-b85f-7547e88c68df;debeaebb-d03b-446a-ac7d-27d3184bf48b;f2901045-904f-47bd-74a1-c561facd7f25;ff01d0cb-bb52-4ba4-9d16-e37e787b903d; |
Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of Asthma in adults and pediatric patients 12 months of age and older. Exercise Induced Bronchoconstriction Montelukast sodium is indicated for prevention of exercise induced bronchoconstriction (EIB) in patients 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp s montelukast tablet products. However, due to Merck Sharp & Dohme Corp s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Allergic Rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. |
Annotated Indication CUIs: C0015263;C2607914;C0004096;C0035457;C0018621; |
RXCUIs for this Label: IN=88249 SCDF=374624;378682; SCD=200224;242438;311759; |
Similar Labels: 09692f56-468c-4884-ae95-d2fb9d984e4c;3c170992-0023-4ae1-90de-e7260448ce07;3d4451a9-d73d-b9de-68ec-853bfeff6e4b;4eabe2b1-7f4d-4720-bf70-191e6df67c79;6d69e73a-76cb-4ece-9cf9-e9adb4f523b4;7636a692-558f-4649-86d9-b6699c3eeca1;7caa5173-dacc-4ab4-aa6f-3324001cddc2;9794b747-3a45-48eb-9c3e-bc5b015f6591;a5620aa9-3028-48e1-a9d2-0860a8fe7e1d;b2de3aab-8346-047c-9e34-de9fec43fb39;b5f0e397-55f7-47c0-b1d4-377ce48dd9a3;ba42b0a9-83f1-4283-a853-f99cdd0761b9;c43d1edb-c162-4317-9a89-d84e4eff5512;c5d2963f-3b67-40cb-9731-245d095bc668;d606a983-3146-4f50-a9d5-634cb4aef580;da038cf6-cfad-43a4-ab8e-d81d028d6087;ed2caffa-a75c-1c27-ae30-2d8280eaea7d;fb58bfdc-f799-4498-bd23-b1655a3d3ac3; |
Palladone Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around the clock analgesia with a high potency opioid for an extended period of time generally weeks to months or longer. Palladone Capsules should only be used in patients who are already receiving opioid therapy, have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine day, or at least 30 mg oral oxycodone day, or at least 8 mg oral hydromorphone day, or an equianalgesic dose of another opioid, for a week or longer. Appropriate patients for treatment with Palladone include patients who require high doses of potent opioids on an around the clock basis to improve pain control, and patients who have difficulty attaining adequate analgesia with immediate release opioid formulations. Palladone Capsules are NOT intended to be used
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. |
Annotated Indication CUIs: C0278140;C0278139; |
RXCUIs for this Label: IN=3423 SCDF=372427; SCD=897677;897687;897730;897737; |
Similar Labels: 706e938f-a0a0-42f6-b99b-60c31cbfb441; |
Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of Influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of Influenza A virus infection. Because amantadine does not completely prevent the host immune response to Influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an Influenza A outbreak, amantadine prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by Influenza A virus strains especially when administered early in the course of illness. There are no well controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of Influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by Influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules.
Parkinson's Disease Syndrome Amantadine hydrochloride capsules are indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson's disease, amantadine is less effective than levodopa, ( ) 3 (3,4 dihydroxyphenyl) L alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established. Drug Induced Extrapyramidal Reactions Amantadine hydrochloride is indicated in the treatment of drug induced extrapyramidal reactions. Although anticholinergic type side effects have been noted with amantadine when used in patients with drug induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs. |
Annotated Indication CUIs: C0030567;C0021400;C0877854;C0242422;C0030568;C0030569;C0042769; |
RXCUIs for this Label: IN=620 SCDF=370558; SCD=849389; |
Similar Labels: 01417F60-DBF3-4041-BF3C-51E6C9216F06;062b646c-5ad9-4836-9e47-8678e1f2da7e;070d3275-4b91-441f-a4e6-5a67b7d768a5;14452da8-3b48-497d-9017-bdfb967b7f56;15e83cd1-79a7-4a96-bc18-7818228a4877;17f205dd-0feb-4c49-a0e1-2d0c362c6bd7;2b6e5b07-b3ba-4717-9ccd-029c0b08cc7f;33a3e25d-80fa-479f-a419-d9487281deff;4fb81272-194b-476e-a5a9-ea5c1d31c69f;5232b933-1df9-43b4-8ac2-61bfa4855e68;620eb102-b6b7-4107-9d9d-018f3c70bf99;63d9d4aa-5f92-45b0-98d0-d6ec38b727cb;7ef565b0-00ac-428e-b00c-e0c905659ecd;87db36f3-c831-4a84-a3c5-e9d6cc7191af;944ab74b-2657-4821-9f2a-e695b5f24d97;a2caed21-e9a3-228e-70a8-de30a1b368be;a8e74473-aaf7-47b5-9266-1d0814b06fdb;b208a0ad-a5e6-4f62-97a1-9f7a480fa325;c40ecd11-0b6e-4f13-bfba-8f011c60ca16;c446aed2-1add-4b09-9cc2-69ab95ae12d2;c74c9424-278d-4a52-8866-db66f6c3ac67; |
Seizure Disorders Clonazepam is useful alone or as an adjunct in the treatment of the Lennox Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder Clonazepam is indicated for the treatment of Panic Disorder, with or without agoraphobia, as defined in DSM IV. Panic Disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6 to 9 week trials in Panic Disorder patients whose diagnoses corresponded to the DSM IIIR category of Panic Disorder (see CLINICAL PHARMACOLOGY Clinical Trials ). Panic Disorder (DSM IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). |
Annotated Indication CUIs: C0030319;C0014544;C0014553;C0001818;C0014550;C0238111;C0595948;C0347869; |
RXCUIs for this Label: IN=2598 SCDF=371579; SCD=197527;197528; |
Similar Labels: 1617e8e2-54a8-4119-b865-d20d2350df3e;1aef0069-80ea-483d-ac70-c8d485462c5b;1db2ad9e-1a0f-4903-9129-7b2c1eb34266;1e1f2ba3-7b22-4f24-b707-c6d002b96f87;26b1d362-e727-49db-9e81-ee80ca97795c;2a005db6-1b26-3187-d3ad-bd3334100de2;38538a48-3f73-d43d-6d1d-fd87247ea4d1;3a9d9447-4459-439e-8792-6016bf4bccfc;3b4a0f73-24fc-435a-bd2c-f2bea57b670b;46881a4c-0c1b-4970-a37b-52f5438f0356;49d24679-eafd-4cf6-b011-b6b5c3fc15ef;4d586471-8b20-4899-94ad-31e0a519e99e;52a03dbc-0510-40ec-8a33-15bf1c404622;542f22e8-dad2-47a8-93b6-30936715d73b;56932302-d7e0-4b4b-ae10-3b64b56dab1c;6ceb3755-486a-4ee3-869d-ffaa39bc53d8;711d9458-4f79-4a75-84c5-95f8068bde70;79a3305b-be80-416f-a346-5a907f7b669e;7fe78a8d-1e6a-431e-958e-f1f1b420efa2;87d39a93-7a51-4662-8e57-f9950c995caa;9a29cc1b-df4f-489a-85ee-82eadd18b218;9af9e5de-69a6-48b3-aa53-f0a7898d51e7;ACBCE0E8-5098-4785-943B-8BDB5FF17FAB;a0a964e0-ffee-4c25-89b0-2d0887fb51f0;a58fe03c-2b5c-40dc-b592-3e376b2dc9f0;ae7bbf44-c5af-4bda-bc22-2388498ad529;af2385dd-0a2d-4e64-86c8-d6616f48fb9d;b8211ed9-1c60-3199-d218-5c3367b066ab;bc74a2bf-86ab-4bd4-9b36-75467f83b541;bd7c463b-eee6-496a-a781-91ca48629f7d;bda569c3-106c-41c1-913c-6f6e8e60bfd4;be578419-3419-4e9e-88ba-18c6ca660642;ced338a8-903f-4919-bf87-a375ae8ea219;d4a99e71-878c-461f-869c-563d246272c0;d5e73906-9a82-4c81-9325-03aa8ae2808a;e0c27a29-b895-4132-a2c2-8da4c0722d03;eb75c672-8c72-4967-b97b-4119d49a9cb1;ebc11109-e7bf-452d-b675-4b3236d54164;ec0e596c-baca-417d-8aa4-a1878100064d;ec134b69-3d24-44d3-b890-7ea641f5e502;f78213e2-c758-4a1d-810f-f9b2c2c35ecc;f90f8801-e566-4288-b661-f31450aff84a;ff316953-15c5-434d-abbf-7b675492e2cc; |
Orphenadrine citrate extended release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. |
Annotated Indication CUIs: C0184567; |
RXCUIs for this Label: IN=7715 SCDF=373158; SCD=994521; |
Similar Labels: 0f50125a-6d89-4b2b-b48b-daac6129182c;233915f1-7d58-4b4c-a2bb-e73179d61d07;2753a96d-406b-47d1-b0a5-3f9e0cebd789;28d5753e-862a-4811-8b9f-6707361f8475;34769dda-f555-460e-9064-98ab205393c5;7b76c8a7-dd0c-481c-8299-26dfd38ce066;8408d24e-3948-548d-bb12-b1edf0c05e12;8768cd6b-e79d-4b6d-8981-2f01ce28047b;8ca9438d-320f-4499-aee7-6b8ca7cccc65;c840e4b6-5b96-4346-8298-1078c166327a;c8d8596a-b81f-4b83-a2f3-a55922ca4a82;cd5ca6c6-0132-81bf-3307-1c321f716500;d0ea1b70-97a9-4593-905e-93c53ead73a7; |
Major Depressive Disorder Fluoxetine capsules are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re evaluated . [see ]. Clinical Studies (14.1) [see ] Dosage and Administration (2.1) Obsessive Compulsive Disorder Fluoxetine capsules are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) The effectiveness of fluoxetine capsules in long term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods, should periodically re evaluate the long term usefulness of the drug for the individual patient [see ]. Clinical Studies (14.2) [see )]. Dosage and Administration (2.2 Bulimia Nervosa Fluoxetine capsules are indicated for the acute and maintenance treatment of binge eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa The physician who elects to use fluoxetine capsules for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient . [see ]. Clinical Studies (14.3) [see )] Dosage and Administration (2.3 Panic Disorder Fluoxetine capsules are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients . The effectiveness of fluoxetine capsules in long term use, i.e., for more than 12 weeks, has not been established in placebo controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods, should periodically re evaluate the long term usefulness of the drug for the individual patient [see Clinical Studies (14.4) ] [see ]. Dosage and Administration (2.4) Fluoxetine Capsules and Olanzapine in Combination Depressive Episodes Associated with Bipolar I Disorder . Fluoxetine capsules and olanzapine in combination are indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax |
Annotated Indication CUIs: C0853193;C0006370;C1269683;C0028768;C0030319;C0001818;C0042963; |
RXCUIs for this Label: IN=4493 SCDF=372231; SCD=310385; |
Similar Labels: 02d91219-7a5b-492f-b0f6-6de0d0236542;02e761f7-24e4-4685-8fb5-0fe9cbbff8f7;06d71a33-5578-4012-b11d-764f45bc1e6a;0a2787f9-0166-4fa7-9f02-7d355609dabf;0d97a780-be38-4f5e-ba45-d3b5be262c63;0e31b689-9a56-4222-b4ec-055ff44b5ee5;0e817af0-85f5-46a5-82a4-e08b1f701e86;1cbda269-2d69-453a-abe3-734a684d835a;1dc008e7-5b9b-ddcd-c369-9dc080bbd00b;20274ff0-f18c-4333-afab-e85ea236dea4;28d1233a-12b6-4b24-9ab6-079b005826ae;2ef69eb9-ef5b-431f-aeb2-34fc360a7bb5;35fee753-acd7-4da2-bd60-973dc6c0b21f;369dbfba-9de4-433c-8680-2ec047b8f8d9;37bc2c81-ac05-4a7f-aa8f-cc138dd9b895;3ccada47-7eb9-285d-5059-06afb4466114;4410511e-48ea-4ff4-9535-752863a0ee8f;45454555-7402-41cb-a452-e6a76e04f387;464d0fc2-b307-42dd-853d-9d878358d6af;4e81573a-ea76-47f8-897e-0e1d98550e46;59de2889-c3d3-4ebf-8826-13f30a3fa439;5e47c25f-c865-470d-8ea3-b4f9ca2ba5ba;5e814a91-4bb2-4c8d-bdb5-c64ce5babf07;5f356c1b-96bd-4ef1-960c-91cf4905e6b1;608d4639-06d7-4b0d-ad2d-02e556c17f7c;62c47df4-2c71-437e-b142-bc193f6277f0;662f3e16-bf42-4127-8e56-4eb45780e059;6bc0214b-b6f9-463d-a689-a93e59512b60;7125a96a-0e98-4984-8b57-a2e7a99b7b0d;821b8070-9f6c-4810-8eed-d42a31627d3b;837a3746-7f9a-43a5-a021-e70856df34ee;8609ed02-0b30-4c82-bab1-4d51d92ec224;88989ab9-8143-404d-8488-67a289e525b4;894ece20-b681-4b7b-a452-113844594b31;8953d343-d137-4ca5-a73f-3ceff1505b55;930a8a8c-a81a-4110-bb2e-c87e531cbd83;9ab14775-86b8-4a84-bec5-007dd29f3101;9e1353d7-83d1-4522-9352-5545db044a50;a1575590-4bdd-4f66-91fb-337e5f681747;a2d6beb9-bec4-4623-bcc9-7f1bfddb9f0b;abccfe74-aaf9-4729-a196-2d666f9562b5;ac0fe5db-e89e-4de7-9bba-15c966776f2a;aca0b44e-598d-490b-87f4-f6701d1aad9e;b050b0ee-107c-4f82-8031-92ec68baa6a2;b07f9eab-44ac-4667-bd46-52d736daa5d6;bb06af33-8ff7-0b02-0029-d628f62e1382;befdb67d-62e6-4f40-9183-30b6e0718c53;bfd18a45-06cc-4281-b181-40eb5d192a9b;c3edb2c8-acff-47f6-aa8a-21a07287cd76;c88f33ed-6dfb-4c5e-bc01-d8e36dd97299;d31c9625-30c8-4efd-a31f-13930705d573;d534867a-e4ef-46ce-b61d-857387ce450a;db1c840d-ab22-4a4c-9ced-ae82c869dd9b;e07fa54e-f4ee-496d-a7e9-533c85564be1;e5336cf0-04c9-45f2-b364-5d9132726c52;e6c2595a-1470-4cf4-93ea-0fedf917cf85;e9d6c462-84af-4371-bc05-78cb0bcb589d;ecd112ab-7420-4fe4-9288-a3f1fd83eee1;f27ef79a-d212-4752-8300-b88b61d0464d;f719162f-cb78-487c-b172-ac10d009e6f5;f7994951-93d4-42cb-88f5-b8ad8e9f5037; |
Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total C and LDL C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention Of Coronary Heart Disease In individuals without symptomatic cardiovascular disease, average to moderately elevated total C and LDL C, and below average HDL C, lovastatin tablets are indicated to reduce the risk of Myocardial infarction Unstable angina Coronary revascularization procedures (See CLINICAL PHARMACOLOGY , Clinical Studies.) Coronary Heart Disease Lovastatin tablets are indicated to slow the progression of coronary atherosclerosis in patients with Coronary Heart Disease as part of a treatment strategy to lower total C and LDL C to target levels. Hypercholesterolemia Therapy with lipid altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to Hypercholesterolemia. Lovastatin tablets are indicated as an adjunct to diet for the reduction of elevated total C and LDL C levels in patients with primary hypercholesterolemia (Types IIa and IIb***), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Adolescent Patients With Heterozygous Familial Hypercholesterolemia Lovastatin tablets are indicated as an adjunct to diet to reduce total C, LDL C and apolipoprotein B levels in adolescent boys and girls who are at least one year post menarche, 10 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present LDL C remains >189 mg/dL or LDL C remains > 160 mg/dL and there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the adolescent patient General Recommendations Prior to initiating therapy with lovastatin, secondary causes for Hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total C, HDL C, and TG. For patients with TG less than 400 mg dL(<4.5 mmol L), LDL C can be estimated using the following equation LDL C = total C [0.2 x (TG) + HDL C] For TG levels >400 mg dL (>4.5 mmol L), this equation is less accurate and LDL C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL C may be low or normal despite elevated total C. In such cases, lovastatin tablets are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below After the LDL C goal has been achieved, if the TG is still 200 mg dL, non HDL C (total C minus HDL C) becomes a secondary target of therapy. Non HDL C goals are set 30 mg dL higher than LDL C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL C is 130 mg dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL C, the NCEP recommends that LDL C levels be used to initiate and assess treatment response. Only if LDL C levels are not available, should the total C be used to monitor therapy. Although lovastatin may be useful to reduce elevated LDL C levels in patients with combined Hypercholesterolemia and hypertriglyceridemia where Hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V).*** *** Classification of Hyperlipoproteinemias The NCEP classification of cholesterol levels in pediatric patients with a familial history of Hypercholesterolemia or premature cardiovascular disease is summarized below Children treated with lovastatin in adolescence should be re evaluated in adulthood and appropriate changes made to their cholesterol lowering regimen to achieve adult goals for LDL C. |
Annotated Indication CUIs: C0010054;C0020445;C0020443;C0027051;C0002965;C0004153;C0242339;C0020557;C0342879; |
RXCUIs for this Label: IN=6472 SCDF=372652; SCD=197904;197905; |
Similar Labels: 058b94d0-9811-4dd2-a28d-377a26e5e6f8;0a680e13-0356-4e08-a7fe-78b96ba51b9d;0e15feec-d27e-4861-8152-c5a8b8ccacd4;10a557fe-6620-4b15-862a-d3ff5dece612;15ca7e87-e640-4788-b3d5-a15a0e3aa034;165c9a95-de9b-44fc-a26a-40737a0d6bfd;18e678d8-f1cd-4970-8ae1-f701186180a4;18fae555-8c03-4cec-8c65-c7fdaea4b958;1ac3b68a-ca60-43c5-a208-f92f10008521;347c802f-4ea9-41d4-80d6-e4a183f22179;3895e5cb-14d0-4676-9e57-3c224806bf3e;41b6dbdc-a41a-426e-8ad4-c5d52ee87ae8;462dce28-bed1-4885-972b-a6e1028fcead;4fc5df6d-9253-409c-9c4f-26159aa651bd;50b7fc3e-de79-4b08-a2b7-b05110ec70fb;520428f1-2cd5-447f-8782-c8505ce65b72;5a33d7f7-6a79-62df-baaa-57950e256842;5f2cff3a-8862-4c87-90aa-0ca16def7914;61caf965-1172-4200-ad56-a3815388c044;722a733e-60ee-4ef8-83d8-a3196160ac76;73f92f9b-3715-4699-ba60-1ffecd677e23;8c2ead65-6489-4841-9bd8-97165b94aab3;8d2199d5-80bd-497f-8c74-f3e613b9800d;930C6836-88DC-483F-A95E-481522D2DD68;9ab4e06f-2d51-4247-bf43-4636b416e96a;A694C480-76F3-42C3-BB67-BED50E12C1AE;b1f9a948-f807-4256-b221-e431167f9d54;b6442f16-1548-4224-b03d-cf6f672055ad;caf7c3af-8256-4557-af40-e8143e9af9f1;d3620ebe-87e1-4a93-96cc-ff20ddbb30b2;d8d3b5b9-7ac7-445a-96c7-b5218417d9f8;db39f510-b247-46a4-a5ad-8da13697ec0c;df7ddf4f-d569-431e-81f1-9129d7043150;e8b6ccc2-e6e7-45fd-ab66-c312bcbe2b01;f5766e3f-374d-47b5-b141-2767cb7a4693;f65dbfca-bfb4-42ed-9b05-34769d81d04c; |
Carefully consider the potential benefits and risks of ketoprofen immediate release capsules and ketoprofen extended release capsules before deciding to use ketoprofen immediate release capsules and ketoprofen extended release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen immediate release capsules and ketoprofen extended release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended release capsules are not recommended for treatment of acute pain because of its extended release characteristics (see CLINICAL PHARMACOLOGY Pharmacokinetics ). Ketoprofen immediate release capsules are indicated for the management of pain. Ketoprofen immediate release capsules are also indicated for treatment of primary dysmenorrhea. |
Annotated Indication CUIs: C0029408;C0030193;C0149875;C0003873; |
RXCUIs for this Label: IN=6142 SCDF=372535;372536; SCD=197855;197856;314058; |
Similar Labels: 198a4140-f4c0-4478-9157-ee1d68d0bb96;51f3222f-bc05-4117-881d-85880b092e42;6b36cfde-9ecd-4532-88ee-14261f729d06;79f475c8-f978-c0ee-b900-f270b59c492d;9bc31f67-cfce-4ad6-9c07-3845ead3542c;b3180408-a3c0-4e02-8535-dea390a52277;b7967cca-921e-49af-b64b-78c87ca7f776;c2c99853-1268-4998-a44b-2bf0c0b70fd2;d471d6b5-2a16-41a0-9058-cbe5dfa3011f;dc21a4f9-d8f3-4804-ba3e-a26cae143f26;ecf6bc02-233d-2c3b-1ba0-e5d708338e45;f0d14edb-7e04-4155-8034-1bed7f0318b0;f9d258bc-2ae3-4cc8-a5d4-987164c1e0b4; |
Schizophrenia ABILIFY is indicated for the treatment of Schizophrenia. The efficacy of ABILIFY was established in four 4 6 week trials in adults and one 6 week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see CLINICAL STUDIES (14.1) ] . Bipolar I Disorder Acute Treatment of Manic and Mixed Episodes ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3 week monotherapy trials in adults and one 4 week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6 week adjunctive trial in adults [see CLINICAL STUDIES (14.2) ] . Maintenance Treatment of Bipolar I Disorder ABILIFY is indicated for the maintenance treatment of Bipolar I Disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see CLINICAL STUDIES (14.2) ] . Adjunctive Treatment of Major Depressive Disorder ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD). Efficacy was established in two 6 week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see CLINICAL STUDIES (14.3) ] . Irritability Associated with Autistic Disorder ABILIFY is indicated for the treatment of irritability associated with Autistic Disorder. Efficacy was established in two 8 week trials in pediatric patients (aged 6 to 17 years) with irritability associated with Autistic Disorder (including symptoms of aggression towards others, deliberate self injuriousness, temper tantrums, and quickly changing moods) [see CLINICAL STUDIES (14.4) ] . Agitation Associated with Schizophrenia or Bipolar Mania ABILIFY Injection is indicated for the acute treatment of Agitation associated with Schizophrenia or bipolar disorder, manic or mixed. Psychomotor Agitation is defined in DSM IV as excessive motor activity associated with a feeling of inner tension . Patients experiencing Agitation often manifest behaviors that interfere with their diagnosis and care (eg, threatening behaviors, escalating or urgently distressing behavior, or self exhausting behavior), leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the Agitation. Efficacy was established in three short term (24 hour) trials in adults [see CLINICAL STUDIES (14.5) ] . Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with Schizophrenia, Bipolar I Disorder, and irritability associated with Autistic Disorder is indicated as part of a total treatment program that often includes psychological, educational, and social interventions. |
Annotated Indication CUIs: C0349208;C0085631;C0004352;C0853193;C1269683;C0338831;C0036341;C0005586; |
RXCUIs for this Label: IN=89013 SCDF=378301; SCD=349545;602964; |
Similar Labels: 0424faf3-202f-438a-b65e-2a228790b8f9;16710a27-aa76-4dd7-92e8-7d3c7efe3e42;217e52b5-3a7b-4bbe-af3c-b18de7d426c3;231e2433-31fe-4612-80f0-ba00dee3b26a;440012b2-4fab-4e2e-ba7f-6ca5558d1e23;b6243233-8846-4ea8-a2fa-a563e48fdc29;c040bd1d-45b7-49f2-93ea-aed7220b30ac;d8275c2d-f42d-4f32-aa9f-03a202c8e99f;d9fc9628-40da-4eaa-ba7e-412c90abe35c;e8fe516e-25fc-45f6-9a88-542deaa1c3e8;ffb6ef30-2619-4652-864c-4d5e94526a15; |
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms
To reduce the development of drug resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C2242472;C0029882;C0035243;C0149524; |
RXCUIs for this Label: IN=2231 SCDF=371345; SCD=309114; |
Similar Labels: 037608ba-5c96-42a3-92a6-fb956bf2516d;03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d;0bca5df2-55c2-491f-9283-f68f2b04c405;10d94a20-5b0d-4d39-934e-9595be20b7bb;12b6bac5-00a3-437b-a172-d4e09c273c8c;19307ff0-71de-477b-965d-ea243e5ede3a;1d3e6d33-5dc2-498e-8efa-e3c4fca15dff;1fc40f29-1d19-4ee3-97d3-f9dddf27f2ae;22ab5dba-bfce-498d-a644-9ca0e343b1cf;25b87a16-3e28-45b5-9ae8-98053f1f387a;25ef498a-7a7e-4543-a544-b9d0e99f9cd9;278c84f7-530c-45d5-bdcb-78a3cc1a3700;27f5aa5b-28ca-4154-b37e-18a931bf3398;2b388b1e-cd59-42de-ba72-858485b070b7;2b425c29-a6eb-448b-b317-7a360c5a9b55;309584ff-4353-44bf-bdaf-851ceb0ca7c3;37ec3f8b-51d1-4d74-a4ee-9240c734b1a6;3fed2817-fc0d-43cd-9f02-948fbc76672c;45d5d3f1-43e6-41e4-b2b4-51ba9085a526;4e334e50-19c4-449b-b77f-549a461c7f84;561d93f2-0282-4dec-bac9-840923657df7;5681d4d2-9b67-4cac-9b94-8368f9978231;5de0f7c1-d152-45f7-bfb7-9e5404d9f74b;5dfec608-4a61-45d6-b535-42c4cb8a170c;5efa48e3-1f8e-4a69-b41f-bf1adc754f94;68fba58a-7748-4581-8432-f5286c46d90a;6abc40af-be15-405e-845c-c31866b3d6f6;6ce11859-aa21-4b3f-bd59-3cd26deca82b;6fa9d90d-d3da-47eb-859c-ad5589d3e1a9;704ed0b7-4ad3-4bb6-beac-221d20238216;715cecc7-27e4-4cb6-9ba4-9d81b734480b;75262b2e-4b10-4a37-b32a-828f17aebd03;7ae019f7-ae75-4a5a-a7a7-38cb0992c127;803cdf4c-77ec-4b9b-bc2d-873eb236f9c7;80f6f146-a91c-4452-bc83-2e47c5671d91;8494bec5-8404-43e4-bfa1-a7270b8dfbf7;87f388c6-c942-47f5-b685-0f7ce0e431f4;88c0130e-d901-43da-bd37-14704be586d5;8e28f049-6110-4473-830f-c494191a7197;9a75fb7c-c249-4885-8a8f-78678b537452;b5da860d-9cfc-4020-bc81-11f2a01e660b;b8136dc3-3942-4c72-a18c-00a6d823887d;c5604b48-d58f-45ac-8602-72241ed4b906;c5f1a7f6-a5a4-48f1-9022-d6d402bfd349;c6d56d5e-856e-4e48-85f7-fce2beade4d1;c9202158-e3e4-4efc-9cc7-58e92d7fde8d;cb31cd1b-100d-4a24-b314-1ddcd6a95314;d5baab72-2d4b-42aa-973e-860a22b23a90;d9a049bd-2161-4a9b-8f6d-0c7d2bfdb0ed;de8d97fd-3a76-4019-a640-882066c25c19;e2447895-d026-4829-a942-50c670d55cb2;ec678657-42f1-4a51-a596-129033e2ff60;effe46a4-c383-4171-8ab4-2af9de316f08; |
Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders 3rd edition (DSM III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms depressed mood, loss of interest in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open label treatment was demonstrated in a placebo controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY ). |
Annotated Indication CUIs: C1269683; |
RXCUIs for this Label: IN=15996 SCDF=378384; SCD=311725;311726;314111; |
Similar Labels: 010f9162-9f7f-4b6d-a6e4-4f832f26f38e;0201a4eb-f127-4e45-92a7-b65a1af65b24;10c0ed21-833a-4267-b388-56d0c1ebada8;1501000f-664d-42ef-bff0-f85a7996b11c;18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8;2373655d-ac74-43f5-a041-9f41a5b92206;310d8699-2c46-44e8-8c5f-79f01517a4a6;34c0b734-98ca-4aec-965f-e55edd3317f3;3a8a4490-9243-4201-944d-cea27d3d69f5;3c7b2832-44fb-42eb-acb9-374346505e84;3c8cb887-1bce-4902-90d2-4355506c4197;4531cb5a-64ca-4e6a-98c2-7aaad8d7f630;4801d296-7194-4c8c-895d-0dc1a3e6eb25;5542170c-79d3-4c5d-8008-50f2cdcb4f0a;59c61b34-d646-4cd5-8262-3df160064f4c;6837b69b-2f86-42cf-b48d-b4a3c7b5413f;711aa80b-8fc6-49e6-9494-3db31d9b53a4;754EE84C-AD16-4B06-BD1C-6791C758F908;82a615a0-e74a-49cb-9a57-ffbb3df604d5;8731e418-0cdb-44d2-b534-382c6467a6b9;89ae6a33-933f-47aa-a2de-2a71cd3f7d44;8b3c5f72-20eb-4e07-9ddf-f4e6b6dfa795;8feda54f-a3fa-4108-bfc4-c15b0eab4396;912e850f-a0bf-4e07-a800-43479eeffb05;a4c012f0-50b6-42fb-9f06-a14632f23f2e;aa05d606-29fd-443e-802b-1d65584d6bb1;aad22f7f-33d8-d9c0-5003-091679a7a400;aecec663-16ed-4c34-a00a-af6b99b3e1b6;afc24c74-7567-4c1c-ba93-f103f1df398e;b5e3a5a3-a17a-4f82-8cab-8c11fa8be0bc;b8df747e-dfce-4411-b892-086532ffabfb;d4a251ea-458f-4dd7-b102-53ba947958f3;d9578264-6ae5-44e3-90af-6ba61fe270a5;dd2f25f6-7688-48e1-92e7-aab152ff7413;e2a39ae4-774c-46c3-b978-0aa4110fef2c;e4d52964-e5ef-4ecc-9e22-03e1305a769a;f23631be-c7ae-46e9-b771-a70be17bc9f0; |
Therapy with lipid altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Prevention of Cardiovascular Disease In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to
Hyperlipidemia Atorvastatin calcium tablets are indicated
Limitations of Use Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V). |
Annotated Indication CUIs: C0018802;C0020473;C0002962;C0010068;C0242339;C0020445;C0027051;C0020479;C0342879;C0038454; |
RXCUIs for this Label: IN=83367 SCDF=370621; SCD=259255;617310;617311;617312; |
Similar Labels: 10a7ba02-42d6-4cae-8904-b256e2da5496;17a163ef-b349-4e32-bc8c-b02bac7f65d6;194218c4-3f18-4b6b-a0d9-acc8c862d4b7;200601d6-2c98-42dd-bece-76fc350c5356;28e28cc3-349a-427a-b19c-77503ef43db4;2a8de5aa-936a-493e-a0e3-813cbc969c6d;4053ed16-9219-4657-b86f-52ef6b66d005;634ec8e3-6d83-4cb2-90a3-fc9c973b06bf;6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d;7fcb451e-4834-4905-852b-ec1efe9115f0;808c5c03-9fd7-4d8b-b4d0-57c7527b42df;865f4e70-ead8-4480-96a4-6ca7b7d8ed69;8a201c80-a51d-4c1c-963b-488c071908c0;901550e6-22be-68c9-eb86-f85a9c9dd998;a3c08a6d-f986-4efc-9f96-3f0e652704dc;afd5c7b3-4886-4250-9a12-b61451f65eb5;c6e131fe-e7df-4876-83f7-9156fc4e8228;d385e07a-c16f-4aef-8e55-af95bd1c7526;d9adb9e4-c495-9530-e5e3-7e3b01d53e4c;da09f66e-9093-4e07-9820-e7d8ccd594f3;e480e538-4ea7-47e6-9e5d-dc0f8179e06c;e556c1d1-f677-4fc1-a2e9-406bc4b7fb9e;f60a672d-8d6d-4d67-9a47-5547357e7b5b;fb8ef96b-ed37-4439-9294-834ef2e2a7c6; |
Therapy with pravastatin sodium tablets should be considered in those individuals at increased risk for atherosclerosis related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors. Primary Prevention of Coronary Events In hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin sodium tablets are indicated to Reduce the risk of myocardial infarction Reduce the risk of undergoing myocardial revascularization procedures Reduce the risk of cardiovascular mortality with no increase in death from non cardiovascular causes Hyperlipidemia Pravastatin sodium tablets are indicated as an adjunct to diet to reduce elevated Total C, LDL C, ApoB, and TG levels and to increase HDL C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). 8 Pravastatin sodium tablets are indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). Pravastatin sodium tablets are indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. Pravastatin sodium tablets are indicated as an adjunct to diet and lifestyle modification for treatment of HeFH in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present
Prior to initiating therapy with pravastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure Total C, HDL C, and TG. For patients with triglycerides (TG) < 400 mg dL (< 4.5 mmol L), LDL C can be estimated using the following equation LDL C = Total C HDL C 1 5 TG For TG levels > 400 mg dL (> 4.5 mmol L), this equation is less accurate and LDL C concentrations should be determined by ultracentrifugation. In many hypertriglyceridemic patients, LDL C may be low or normal despite elevated Total C. In such cases, HMG CoA reductase inhibitors are not indicated. Lipid determinations should be performed at intervals of no less than four weeks and dosage adjusted according to the patient s response to therapy. The National Cholesterol Education Program s Treatment Guidelines are summarized below After the LDL C goal has been achieved, if the TG is still 200 mg dL, non HDL C (Total C minus HDL C) becomes a secondary target of therapy. Non HDL C goals are set 30 mg dL higher than LDL C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL C is 130 mg dL (see NCEP Treatment Guidelines, above). Since the goal of treatment is to lower LDL C, the NCEP recommends that LDL C levels be used to initiate and assess treatment response. Only if LDL C levels are not available, should the Total C be used to monitor therapy. As with other lipid lowering therapy, pravastatin sodium tablets are not indicated when hypercholesterolemia is due to hyperalphalipoproteinemia (elevated HDL C). The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below |
Annotated Indication CUIs: C0020557;C0020473;C0010068;C0242339;C0027051;C0020479;C0342879; |
RXCUIs for this Label: IN=42463 SCDF=373560; SCD=904458;904467;904475; |
Similar Labels: 1123d56c-16f0-4f81-b56f-67b1f343ae1e;1ec7ef4d-8ea8-4189-b1ac-b8ac57d7ebe2;2e736bd6-01cc-4180-b97c-dd10b2250630;3ff75342-03b6-462f-b6db-80bc1a52fe6c;44a07041-456a-4b0b-9a8a-9e1715327d33;481cb8c7-578d-4db0-862e-a010b1af47d7;762daef1-2ad2-444d-958b-f0a69c8ac259;969dd35d-fbf5-4a26-b083-d68f10085445;9e58806e-08ba-4813-885a-bde5cf82b26d;AD3DA3C3-66B2-09FE-2C85-AAF4367E3732;a5ca8004-9a18-4030-a56c-8938c4823c64;c129f662-9ae7-45b6-9a02-15b569e051fc;e007e7c6-7d5d-4d5c-9a6c-c82d9e9cfaf7;e4e9610a-765b-4237-a598-0f4b27a4553e;ea2d1275-8437-4979-8199-24eb9678be94; |
Adult Patients Cold Sores (Herpes Labialis) Valacyclovir hydrochloride tablets are indicated for treatment of Cold Sores (herpes labialis). The efficacy of valacyclovir hydrochloride tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode Valacyclovir hydrochloride tablets are indicated for treatment of the initial episode of Genital Herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes Valacyclovir hydrochloride tablets are indicated for treatment of recurrent episodes of Genital Herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy Valacyclovir hydrochloride tablets are indicated for chronic suppressive therapy of recurrent episodes of Genital Herpes in immunocompetent and in HIV infected adults. The efficacy and safety of valacyclovir hydrochloride tablets for the suppression of Genital Herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV infected patients have not been established. Reduction of Transmission Valacyclovir hydrochloride tablets are indicated for the reduction of transmission of Genital Herpes in immunocompetent adults. The efficacy of valacyclovir hydrochloride tablets for the reduction of transmission of Genital Herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir hydrochloride tablets for the reduction of transmission of Genital Herpes in individuals with multiple partners and non heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines). Herpes Zoster Valacyclovir hydrochloride tablets are indicated for the treatment of Herpes Zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir hydrochloride tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir hydrochloride tablets for treatment of disseminated herpes zoster have not been established. Pediatric Patients Cold Sores (Herpes Labialis) Valacyclovir hydrochloride tablets are indicated for the treatment of Cold Sores (herpes labialis) in pediatric patients 12 years of age. The efficacy of valacyclovir hydrochloride tabletsinitiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Labeling describing use of valacyclovir HCL in pediatric patients with chickenpox (ages 2 to 18 years) is approved for GlaxoSmithKline s Valtrex Caplets. However, due to GlaxoSmithKline s marketing exclusivity rights, a description of that pediatric use is not approved for this valacyclovir HCL tablet product. Limitations of Use The efficacy and safety of valacyclovir hydrochloride tablets have not been established in
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Annotated Indication CUIs: C0019345;C0019342;C0019360; |
RXCUIs for this Label: IN=73645 SCDF=374272; SCD=313564;313565; |
Similar Labels: 11d1e166-9577-47b0-a338-d11ab3ba44aa;1aa34beb-b06b-410c-b483-ba0bd903944a;1ad90fbf-1fae-4f3f-9aea-6a28420e9f10;21a09954-398a-4514-93c3-7bce55384fa5;26634bf1-c6d8-4d48-9a4e-845c47df07f8;2d38cbdb-4e4d-4174-461d-7a3b6475e6a5;2f0ecd75-e4b4-4493-b7a4-1666fc555c70;3172560a-e692-41f0-9ac3-bf6bfb90c4d6;3277c17e-f953-2b0a-fe0a-4f5d1aeace9d;3fc60483-3dd9-4d52-a0eb-fceba330e019;40668538-2526-f573-05c9-f589092e6e81;4acf51de-26f7-42b2-8acc-61b800627ef3;56bf715d-8280-4557-9f98-9693932199e5;61ea67c2-8c0e-486f-8c0c-6167a1d3d95a;6b2db776-4f30-4a17-a250-79654b86eca0;823e203e-acc2-4d75-ae42-f33ca2a1bcd1;a9e1d18e-ad45-4183-bd98-53c7e0b36556;af1fef85-fb8e-478d-999a-5a8adc42baa3;b0e6fa63-7b34-4453-a259-34ffd917f4d7;b28980df-064b-4fd4-8bf3-1589987671ab;b6b16acc-608a-418a-bf53-f0e44d7f123a;bcfc31a1-b604-4cd1-a9e0-681e60d4cd2e;c89fdb3a-99cb-4e47-88bb-782f5e402f15;d7aa2791-95d9-4732-afe4-89d70f01d152;d8028584-4186-41d6-b74b-2535971aa216;e228913a-8f12-4a4f-bc14-ba44d6e9ece9;f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5;f8e0d8f8-cb73-4206-a484-88f5c4fbd719;fc1c497a-8619-4455-8f9f-6ef4f2df00ab; |
Indication Olux E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. Limitations of Use
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Annotated Indication CUIs: C0037274; |
RXCUIs for this Label: IN=2590 SCDF=379105; SCD=861353; |
Similar Labels: a8291f89-c8e2-435f-8226-75a53438d4d7; |
GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. |
Annotated Indication CUIs: C0032768; |
RXCUIs for this Label: IN=25480 SCDF=378099; SCD=310433;476677; |
Similar Labels: 7d12b4e9-ed44-43c0-9e46-f6c195300f03; |
This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion , visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders. |
Annotated Indication CUIs: C0016807; C0037763;C0010692;C0152163;C0000729; C0152169;C0151824; C0009443;C0030920;C0022104;C0559031; C0014356; |
RXCUIs for this Label: IN=153970 SCDF=370666; SCD=1047905; |
Similar Labels: 136a7070-2dca-4157-a470-56dd534f149a;2b4cf7e7-207a-41e8-a573-2739412807a0;2d5fa637-0696-40fe-9bc1-fcb6f07a50f6;2fcc0dcc-9c97-4b7d-91b0-11f5c2fd046a;5361160c-c979-4a4f-8a46-fcf85560c967;5e39fbb6-7865-4252-9ba3-bb841a1cec0b;788d1714-5276-4833-914a-e4d89fa351f1;8504adad-f6d0-4671-b655-4b62bf29a516;cfcda432-1227-484b-9369-84f6bcf66086; |
Hydromorphone Hydrochloride Injection is indicated for the relief of moderate to severe pain such as that due to surgery, cancer, trauma (soft tissue and bone), biliary colic, myocardial infarction, burns, renal colic. |
Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=3423 SCDF=370652; SCD=897745; |
Similar Labels: b325028e-0722-4c8c-9fdb-ab6fb0dc460c; |
Diclofenac sodium delayed release tablets are indicated for the acute and chronic treatment of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. |
Annotated Indication CUIs: C0003873; C0029408; C0038013; |
RXCUIs for this Label: IN=3355 SCDF=371794; SCD=855906;855926; |
Similar Labels: 1C3A94FF-91F0-4BC1-8BC8-1B6AA87E8026;A4FD2D68-019F-4C89-8923-4E61262F6EEE; |
TEMOVATE Gel is a super high potency cor ticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g week because of the potential for the drug to suppress the hypothalamic pituitary adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. |
Annotated Indication CUIs: C0037274; |
RXCUIs for this Label: IN=2590 SCDF=379076; SCD=861434; |
Similar Labels: 29735bf2-e08e-4f60-a640-0e3b9ccca80f;52858738-a71c-4330-a7b3-e9c6c2161e04;736325f3-a369-4d70-b608-3d6ba37b6a6b;b8c0d9e3-498c-4721-bbc9-c1450b56ba14;ecc6049d-2c2a-40e0-8780-158b166af406;f9df643a-015d-4101-ac8f-c1e05b052df5; |
Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage. |
Annotated Indication CUIs: C0010200; |
RXCUIs for this Label: IN=18993 SCDF=371031; SCD=197397;283417; |
Similar Labels: 199a42ae-4d19-4e68-934d-dabd27084988;758cced1-db76-41f4-9bdc-d016637a49cf;83233a7e-856c-47d3-b6af-c6c642694486;ce85fa92-783e-4f71-b7ae-bc0eb0410e13; |
Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron Injection is indicated for the prevention of Nausea and Vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high dose cisplatin [see Clinical Studies (14.1) ]. Ondansetron Injection is approved for patients aged 6 months and older. Prevention of Postoperative Nausea and/or Vomiting Ondansetron Injection is indicated for the prevention of Postoperative Nausea and or Vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and or Vomiting will occur postoperatively. In patients in whom nausea and or Vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of Postoperative Nausea and or Vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and or Vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes [see Clinical Studies (14.3) ] . Ondansetron Injection is approved for patients aged 1 month and older. |
Annotated Indication CUIs: C0027497; C0042963; C0520904; |
RXCUIs for this Label: IN=26225 SCDF=376327; SCD=283504; |
Similar Labels: 866571f1-4b10-423d-8d08-ce9aa65ede51;97713356-f42b-4a67-95f6-561afa68c0c2; |
Azithromycin tablets are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Mycobacterial Infections Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin tablet, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION, CLINICAL STUDIES) Treatment of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin tablet, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION, CLINICAL STUDIES) |
Annotated Indication CUIs: C0032285;C0026919;C0026918; |
RXCUIs for this Label: IN=18631 SCDF=370976; SCD=204844; |
Similar Labels: ac66be47-babc-41eb-b259-03a7020cec23;de7f60ec-40ff-4f5f-8f72-5ff9711cc574;fb0ff563-b87b-439b-885d-49572d3c0c12; |
Clobetasol Propionate Lotion, 0.05% is a super high potent corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses only in patients 18 years of age or older (see PRECAUTIONS ). Treatment should be limited to 2 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl.oz.) per week. For the treatment of moderate to severe plaque psoriasis, localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2 week treatment with Clobetasol Propionate Lotion, 0.05% may be treated for up to 2 additional weeks. Any additional benefits of extending treatment should be weighed against the risk of HPA axis suppression before prescribing for more than 2 weeks. Patients should be instructed to use Clobetasol Propionate Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS ). Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS Pediatric Use ). |
Annotated Indication CUIs: C0037274; C0406317; |
RXCUIs for this Label: IN=2590 SCDF=379392; SCD=861505; |
Similar Labels: 4abecc19-e956-4d05-a51e-73dba23dc131; |
COUMADIN is indicated for the prophylaxis and or treatment of venous thrombosis and its extension, and pulmonary embolism. COUMADIN is indicated for the prophylaxis and or treatment of the thromboembolic complications associated with atrial fibrillation and or cardiac valve replacement. COUMADIN is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction. |
Annotated Indication CUIs: C0038454;C0004238; C0027051; C0034065; C0040038;C0042487; |
RXCUIs for this Label: IN=11289 SCDF=374319; SCD=855288;855296;855302;855312;855318;855324;855332;855338;855344; |
Similar Labels: 02fddbda-e9e1-41f0-b1a9-b46f4f24705c;0750d877-b6f0-46bb-8c1a-46a7c27ebefb;14629e09-a46c-496b-8fe2-1c09ddcd4f71;1509e2c4-2dd3-4e6f-88ca-06e9520d8ffc;23b776e0-7a03-4946-0110-6f70e70031e8;36a919ce-7a21-40c0-9af5-2299bf2b1f97;801e4da1-5459-47d2-b67b-009f0a3247cc;87315917-3e54-44e6-bb64-2f722501c11b;91cecd43-afd8-47a0-963e-167a194ef446;91fa852c-b43d-4a55-983b-74aa6827125d;9321c20d-04f4-2bcd-a080-43c9e45025b2;D174F2B8-FEE2-4817-AD6C-364A1880E24B;a0cfad4b-043e-451e-bfd6-1fe1ac1bd0d6;a1150d78-57cc-4216-beff-f7ea7364ab89;ac5d715d-6b6e-40d5-a5df-e3b884c3ef84;c90be37c-0ad0-4ccd-8fe7-b9a3427f0d80;c95f0b0d-77ef-e753-be04-2228139df2d3; |
PENNSAID is a nonsteroidal anti inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). |
Annotated Indication CUIs: C0409959; |
RXCUIs for this Label: IN=3355 SCDF=393139; SCD=857700; |
Similar Labels: 4732a181-9fe0-49b4-b486-e2da9ad66e31;4a9f22fe-7f2e-4597-beb1-e1f950d2de33;bb530269-5c2e-4821-8fca-2fea108f8f26; |
Carefully consider the potential benefits and risks of Flector Patch and other treatment options before deciding to use Flector Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Flector Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. |
Annotated Indication CUIs: C0184567;C0009938;C0038045;C0080194; |
RXCUIs for this Label: IN=3355 SCDF=371800; SCD=855626; |
Similar Labels: 2cc5e92b-044b-46a4-85eb-bcfe04c9d4be;5e46b7e9-e640-4db5-882f-73a5dd2482d2;A83D7327-ABA2-43E0-A510-9EEABF1BC560;e58641de-b6fd-484c-8902-b9262d7ce251; |
Zipsor is indicated for relief of mild to moderate acute pain in adults (18 years of age or older). |
Annotated Indication CUIs: C0278138;C0278139; |
RXCUIs for this Label: IN=3355 SCDF=376352; SCD=858342; |
Similar Labels: 61420046-b04b-4532-a21d-65986966f681;b20c6938-cf96-4175-9eb3-d6ae3a43059c;fa385cd1-c221-11dd-ad8b-0800200c9a66; |
Clobex Shampoo is a super high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in patients 18 years of age and older. Treatment should be limited to 4 consecutive weeks of the potential for the drug to suppress the hypothalamic pituitary adrenal (HPA) axis. There were insufficient numbers of non Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety. |
Annotated Indication CUIs: C0406326; |
RXCUIs for this Label: IN=2590 SCDF=438709; SCD=861490; |
Similar Labels: 13cdccfa-f8fc-4b81-8fa7-1fa5a8da0338;9539c24e-3fc4-44a6-a40c-bb53260df2f2;a4f82a4c-bc7e-4927-936e-add854812559;acb3a25e-5746-4df6-89fd-cf3023e755cc; |
NORPRAMIN is indicated for the treatment of depression. |
Annotated Indication CUIs: C0011570; |
RXCUIs for this Label: IN=3247 SCDF=371709; SCD=1099288;1099292;1099296;1099300;1099304;1099316; |
Similar Labels: 3e593725-3fc9-458e-907d-19d51d5a7f9c; |
GELNIQUE is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see Clinical Studies 14 ]. |
Annotated Indication CUIs: C0878773; |
RXCUIs for this Label: IN=32675 SCDF=831885; SCD=864818; |
Similar Labels: a2a2ca0b-a685-4a60-b9c9-ffc3b6666c97;acf0324b-2fac-4403-bac8-131b3e1cf5cd;c6754623-b14c-4fc3-8719-48eee3119156; |
EQUETRO is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of EQUETRO in acute mania was established in 2 placebo controlled, double blind, 3 week studies in patients meeting DSM IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode (see CLINICAL PHARMACOLOGY ). The effectiveness of EQUETRO for longer term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use EQUETRO for extended periods should periodically re evaluate the long term risks and benefits of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). |
Annotated Indication CUIs: C0338831; C0338831; C0349208; C0853193; |
RXCUIs for this Label: IN=2002 SCDF=485799; SCD=200131;200133;388311; |
Similar Labels: be478f3c-40f6-47cc-8ab9-f420a9372b1c; |
Voltaren Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
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Annotated Indication CUIs: C0029408; C0030193; |
RXCUIs for this Label: IN=3355 SCDF=377959; SCD=855633; |
Similar Labels: 137c4e7a-e671-413e-b687-89490ef98974;1940300f-2b4a-4016-a1bb-21f821797a89;26b2d99e-d471-4758-8aa0-a26ef464eb35;4c9f995c-d687-483a-b6bb-11c8b263681b;60045fc6-f0d9-4f67-ba91-c3b317596437;636dfa0a-0a93-4f22-9f0c-4131bd523df3;e1685937-3980-40e3-8f04-998174fef3a2;ea23fc47-3b7b-4fad-ae34-b6eb6913d957; |
Hyoscyamine Sulfate is effective as adjunctive therapy in the treatment of peptic ulcers. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a "drying agent" in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents. |
Annotated Indication CUIs: C0030920; C0037763; C0022104;C0005697; C0010692; C0152163;C0000729; C0016807; C0022104; C0559031;C0005697; C0695242;C0221037;C0152169;C0151824; C0009443;C0242422; C0026837; C0040822; C0037036;C0020458;C0274704; |
RXCUIs for this Label: IN=153970 SCDF=370667; SCD=1046982; |
Similar Labels: 38f12473-08e0-4970-a6ef-a825cc7de8d8;3a200492-c460-4b19-ac16-b64493904b88;422fe1f6-43d6-4580-8788-b92f8527e10a;480d688d-2103-443c-90cc-feb861bdce13;5bb0d56c-d58e-4f9f-9848-d241cac5b3db;6f31e729-e36b-4b6e-98de-88077b29bf2b;7056cb58-8520-4e5d-bfb3-549c980f6a54;843d2e6f-9110-4b0d-894f-63b1b206b5ec;9899c4b5-e520-41f3-9dbf-e7da12924dd8;a0e8f7d7-9316-4b78-acc8-17519b9b3165;bc07d46e-de9a-43ac-b344-ab29911b1fae;c5049243-5741-4d60-b65e-f3102fa7cc56;c98d2f36-51b6-4b20-a278-27311303973f;ccfdbaac-2c51-46da-82f2-76e76969dbd8;d2b55db1-be5f-4fe0-b31d-21bbe85a34f1;e09f23ca-e6f8-46c3-b713-97b86e3d5c97;e219b697-45d8-4388-8c79-4b98961fc525;e2528b56-c35a-48f1-8d48-495d1be4550f;f33a4774-9fbb-4782-a7e1-068e83b7504d;f4dd9a8f-be58-4fac-b13b-b436589480ca;f9aaec2b-7ae2-459b-8649-afe760ae5fa2; |
Treatment of Seasonal or Perennial Allergic Rhinitis RHINOCORT AQUA Nasal Spray is indicated for the treatment of nasal symptoms of seasonal or Perennial Allergic Rhinitis in adults and children six years of age and older. |
Annotated Indication CUIs: C0035457; C0018621; |
RXCUIs for this Label: IN=19831 SCDF=746820; SCD=746821; |
Similar Labels: ffca32a2-fbef-40bb-b0f0-73f63e18e747; |
CALAN tablets are indicated for the treatment of the following Angina
Arrhythmias
Essential hypertension |
Annotated Indication CUIs: C0002962; C0002965; C0002963; C0699826; C0003811;C0004238;C0030590; C0085580; C0699826; C0741289;C0577698; |
RXCUIs for this Label: IN=11170 SCDF=374289; SCD=897666;897683;897722; |
Similar Labels: 006cf920-04ae-0b53-cb91-85481972abc2;06907eb6-9e1b-44e4-a4c3-f53e2819c559;0c604923-4a37-45ac-ad93-3610a5eadc16;10881745-3a16-44c3-9b94-60433218f1d6;55d5f933-42ff-4c80-a102-0ccb7f76b082;756adc68-e145-4163-bee5-6db7ca0579d8;8676ce2f-2dac-4407-b751-315b57f48577;90841684-4f00-450f-b366-6fc914ca8c54;a0343397-897b-46d6-943f-a87e07e1de10;c9d71191-b32a-44f9-bc5a-283a06884c82;ce2ec7ef-878c-4c30-a848-0de9fd66f437;ed1e0c14-3571-43f9-88fc-5a4d2b598263; |
Levetiracetam injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible. Partial Onset Seizures Levetiracetam is indicated as adjunctive therapy in the treatment of Partial Onset Seizures in adults with epilepsy. Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam is indicated as adjunctive therapy in the treatment of Myoclonic Seizures in adults with Juvenile Myoclonic Epilepsy. Primary Generalized Tonic Clonic Seizures Levetiracetam is indicated as adjunctive therapy in the treatment of primary Generalized Tonic Clonic Seizures in adults with idiopathic generalized epilepsy. |
Annotated Indication CUIs: C0014544; C0751495; C0270850; C0270853; C0494475; C0014550; |
RXCUIs for this Label: IN=114477 SCDF=647120; SCD=647121; |
Similar Labels: a7f5284b-ff9d-4198-ab0f-bb9fd727662e;a92107d6-5006-4f6a-ace8-6e18ab14677c; |
Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high dose cisplatin. Efficacy of the 32 mg single dose beyond 24 hours in these patients has not been established. |
Annotated Indication CUIs: C0027497;C0042963; |
RXCUIs for this Label: IN=26225 SCDF=376327; SCD=312083; |
Similar Labels: 1FE32FFA-3D69-420F-CC81-B10BB1AFD5BA;1cd37c76-84d0-4091-b68c-e2f67127a2e0;2a09af01-3983-466f-8ed8-c849af848b56;693ba38b-4cbe-4a6a-9c80-b9d2f554edce;8e66d883-2977-46c3-be24-41eba7a903b3;d931b294-8834-4c7f-ac05-9aeb078cd86e; |
Solaraze (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. |
Annotated Indication CUIs: C0022602; |
RXCUIs for this Label: IN=3355 SCDF=377959; SCD=855642; |
Similar Labels: 89a7bfbd-051f-4d87-a642-96b0df81b8e2; |
Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. |
Annotated Indication CUIs: C0238298; |
RXCUIs for this Label: IN=10582 SCDF=372594; SCD=1115267;1115269;966219; |
Similar Labels: ce990712-49c1-4f66-9ee4-c770e8ec394c; |
1.1 Acute Treatment of Migraine CAMBIA (Diclofenac Potassium for Oral Solution) is indicated for the acute treatment of Migraine attacks with or without aura in adults (18 years of age or older). 1.2 Important Limitations
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Annotated Indication CUIs: C0149931; C0236018; |
RXCUIs for this Label: IN=3355 SCDF=393225; SCD=859063; |
Similar Labels: d7335594-50c9-4ae2-a3e3-b9a375187b62; |
Theophylline in 5% Dextrose Injections USP are indicated as an adjunct to inhaled beta 2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. |
Annotated Indication CUIs: C0004096; C0008677; C0013990; C0746102; C0028778; |
RXCUIs for this Label: IN=10438 SCDF=377122; SCD=313263;313264; |
Similar Labels: 3e4221f1-dade-4482-b5e5-2d75a96154d6;c3bb34c1-89b2-48c3-9ad2-16b4b2bce5f9;e18c0cee-a592-4c78-e08e-9898b7d4bf12; |
Budesonide is indicated for
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Annotated Indication CUIs: C0010346; |
RXCUIs for this Label: IN=19831 SCDF=1244210; SCD=1244211; |
Similar Labels: 4a578d93-087e-42f7-a258-a49afef41dea;5c73928d-2b96-42f5-1fb9-90965c214c21;70532afa-4006-4883-feb2-927faaee8e20;d361c2ed-99e8-4089-bbba-cbcf2b239228; |
Monotherapy Finasteride tablets USP, 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to
Combination with Alpha Blocker Finasteride tablets USP, 5 mg administered in combination with the alpha blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score). Limitations of Use Finasteride is not approved for the prevention of prostate cancer. |
Annotated Indication CUIs: C0005001; |
RXCUIs for this Label: IN=25025 SCDF=372199; SCD=310346; |
Similar Labels: 220cd180-8a71-4530-b8ca-8864bee9caa0;32266029-c710-44dd-943f-7e31d0afa622;63ed2cec-c677-45bd-a802-64a9ec54046f;77589cc3-c440-4695-800c-82a0e5128a6c;7c01f541-1c88-400c-41a9-7cbb9dee50c0;8330011c-7e20-4a1c-954f-b98bb0ad78b7;f149569c-05d1-4dba-b35a-4ed6a633f776;fde9c9e4-5275-4aa5-8f56-56037b3db0c7; |
Hypertension Amlodipine besylate is indicated for the treatment of Hypertension. It may be used alone or in combination with other antihypertensive agents. Chronic Stable Angina Amlodipine besylate is indicated for the treatment of Chronic Stable Angina. Amlodipine besylate may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine besylate is indicated for the treatment of confirmed or suspected Vasospastic Angina. Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs. |
Annotated Indication CUIs: C0002963; C0002963; C0020538; C0340288; |
RXCUIs for this Label: IN=17767 SCDF=370573; SCD=197361;308135;308136; |
Similar Labels: 11bde4d6-fb19-4783-8664-c0d116ddd2d1;136b1141-c4d4-4151-b9ba-3c148afd5fb3;4336a551-afff-4d92-b05b-2a8e2000feef;5b1e1926-d2d4-8bb1-185c-f0da07247b51;6E9A6C82-9F25-4C71-B09A-929BD5D7B1CF;6d8304ba-1f38-428c-afc6-63a132e559ca;8157ca93-d926-4264-b606-f73b2b38842a;a10fa641-ac6b-466d-bcba-31c678a74be8;ff768f8c-a695-440f-9474-bddc35064288; |
Oleptro is indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Oleptro has been established in a trial of outpatients with MDD as well as in trials with the immediate release formulation of trazodone [see Clinical Studies (14) ] . |
Annotated Indication CUIs: C1269683; |
RXCUIs for this Label: IN=10737 SCDF=376314; SCD=898697;898704; |
Similar Labels: 88c45123-f475-4dd0-bbac-c261868924ef; |
PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. PROPECIA is not indicated for use in women. |
Annotated Indication CUIs: C0162311; |
RXCUIs for this Label: IN=25025 SCDF=372199; SCD=200172; |
Similar Labels: 4e07adb4-7807-47d3-b9a9-2332a3047410; |
KEPPRA XR is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age with epilepsy. |
Annotated Indication CUIs: C0014544; C0751495; |
RXCUIs for this Label: IN=114477 SCDF=807831; SCD=807832;846378; |
Similar Labels: 01fd698a-b7b2-45d0-927c-619abe7a7f6f;0815e947-ecc1-496f-9419-ebdb6a6f24c9;18648f51-a37c-41e1-b451-123bc0cf5446;2919e43b-69a8-434c-a2d2-1f3ecd7554c0;3e75ef6b-142b-906b-7ab6-948a2db98206;4dc61085-f769-4a14-bb99-570264f999f4;4e0cf847-af7b-4eac-80dd-f51db270fa16;5ebddbf4-eeea-4097-9cac-62dd811d0499;63328937-ec82-445b-8bf8-f528f7803326;6ec4db1a-33d2-4ede-be1c-dae2f5c23c07;6ecf5268-7ed3-458e-b281-aec3c51656d7;7cb669d7-d1aa-43b3-a322-0a2eaa13c656;abc9fada-c5c2-4e07-fb8a-4d1518f7657e; |
Diclofenac Sodium Ophthalmic Solution, 0.1% is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. |
Annotated Indication CUIs: C0021368; |
RXCUIs for this Label: IN=3355 SCDF=378986; SCD=854801; |
Similar Labels: 06141D73-9A59-4626-C372-390566602B77;11bf60e0-d81d-4bd3-ac1b-376151d2754d;39dfffb0-612a-48f3-8db5-1a59899b91e9;41c80e79-36fd-4b90-bae1-55d6042c3ca2;52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b;65037222-146c-493d-aa1c-e6df89bf5b8d;6bec35d6-500d-4570-b2ff-ce7b4fc801df;888d7749-bdbc-4788-a215-9c0447aee79a;d9e299df-ad21-4ebb-a7a4-287a4c337e90; |
VANCOCIN HCl Capsules may be administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin resistant strains) and antibiotic associated pseudomembranous colitis caused by difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, VANCOCIN HCl Capsules must be given orally for these indications. Orally administered VANCOCIN HCl Capsules are not effective for other types of infection. To reduce the development of drug resistant bacteria and maintain the effectiveness of VANCOCIN HCl Capsules and other antibacterial drugs, VANCOCIN HCl Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0014356; C1257843; |
RXCUIs for this Label: IN=11124 SCDF=374281; SCD=313570;313571; |
Similar Labels: 0e7ead22-9618-418f-85a1-4d5ed0949f78;17b69d90-d955-4403-84e5-1465379d961c;29785dd0-f94f-48b5-9194-b4a796c464ce;b7f386c7-8b78-4751-b6ae-e171925c2d54;c8d63431-46d0-407b-b350-bb8e57e34f65;dc61c457-0ebe-4cd1-85ac-2830a1b09784;f04711a7-652e-427d-a7f5-65d4a1c3cae4; |
Glimepiride tablets is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. Glimepiride may be used concomitantly with metformin when diet, exercise, and glimepiride or metformin alone do not result in adequate glycemic control. Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of glimepiride and insulin may increase the potential for hypoglycemia. In initiating treatment for noninsulin dependent diabetes, diet and exercise should be emphasized as the primary form of treatment. Caloric restriction, weight loss, and exercise are essential in the obese diabetic patient. Proper dietary management and exercise alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. In addition to regular physical activity, cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glimepiride must be viewed by both the physician and patient as a treatment in addition to diet and exercise and not as a substitute for diet and exercise or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet and exercise alone may be transient, thus requiring only short term administration of glimepiride. During maintenance programs, glimepiride monotherapy should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations. Secondary failures to glimepiride monotherapy can be treated with glimepiride insulin combination therapy. In considering the use of glimepiride in asymptomatic patients, it should be recognized that blood glucose control in NIDDM has not definitely been established to be effective in preventing the long term cardiovascular and neural complications of diabetes. However, the Diabetes Control and Complications Trial (DCCT) demonstrated that control of HbA 1c and glucose was associated with a decrease in retinopathy, neuropathy, and nephropathy for insulin dependent diabetic (IDDM) patients. |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=25789 SCDF=372319; SCD=199245;199246;199247; |
Similar Labels: 18f94d60-1385-483d-abed-b6ef38452225;DBAE4496-6D22-48B0-A100-70F686D7C0BD; |
Levsin is effective as adjunctive therapy in the treatment of peptic ulcer. In acute episodes, Levsin injection can be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Parenterally administered Levsin is also effective in reducing gastrointestinal motility to facilitate diagnostic procedures such as endoscopy or hypotonic duodenography. Levsin may be used to reduce pain and hypersecretion in pancreatitis, in certain cases of partial heart block associated with vagal activity, and as an antidote for poisoning by anticholinesterase agents.
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Annotated Indication CUIs: C0030920; C0037763; C0022104;C0005697; C0010692;C0152163;C0000729;C0559031; C0005697; C0695242;C0221037; C0030193;C0030305; C1621824; C0274704; C0428977; C0152169;C0151824; |
RXCUIs for this Label: IN=153970 SCDF=370669; SCD=1047916; |
Similar Labels: dd2e786c-29a7-40f8-a5f3-7641413f5036; |
MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
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Annotated Indication CUIs: C0034012;C0022735; C0403818; C0022735; |
RXCUIs for this Label: IN=10379 SCDF=378786; SCD=318240; |
Similar Labels: 67e2cc36-a379-11dc-8314-0800200c9a66;91736ab6-139c-4a1c-a81b-f9d8118b24a8;a0af5e80-8d01-4aa9-9f33-926735fdd38a;a1741a0b-3d4c-42dc-880d-a06e96cce9ef; |
AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms CDC coryneform group G Efficacy for this organism was studied in fewer than 10 infections. Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae |
Annotated Indication CUIs: C0009768; |
RXCUIs for this Label: IN=18631 SCDF=706867; SCD=706868; |
Similar Labels: 5dc0f75a-1e14-469f-af4f-c668a32f2328; |
Budesonide Inhalation Suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Budesonide Inhalation Suspension is NOT indicated for the relief of acute bronchospasm. |
Annotated Indication CUIs: C0004096; |
RXCUIs for this Label: IN=19831 SCDF=377279; SCD=349094;351109; |
Similar Labels: 0950cd08-a48b-4376-9647-da22cf5a8a70;214b6a39-9d7f-4c4d-8e40-a5c4ef05c3d8;2414058b-5d39-42f2-915f-03a5e1101ab5;2e0fa140-85a0-42db-ba15-a068120076b4;33cd9834-76df-4f26-3fa2-aab6b9eee8f2;4f339e84-33be-44d1-bbae-e0579da12c7f;ca6ae964-3b4b-4c24-a939-0100791ce1fe;cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb;d70092e2-07e2-4a23-aa6a-0e2444e12ee2; |
STROMECTOL is indicated for the treatment of the following infections Strongyloidiasis of the intestinal tract . STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) Strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open label designs, in which 64 100% of infected patients were cured following a single 200 mcg kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies .) Onchocerciasis . STROMECTOL is indicated for the treatment of Onchocerciasis due to the nematode parasite Onchocerca volvulus . This indication is based on randomized, double blind, placebo controlled and comparative studies conducted in 1427 patients in Onchocerciasis endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC C). NOTE STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with Onchocerciasis, since this procedure will eliminate the microfilariae producing adult parasites. |
Annotated Indication CUIs: C0029001;C0348997; |
RXCUIs for this Label: IN=6069 SCDF=370726; SCD=311207; |
Similar Labels: 681888c9-af79-4b7d-ae80-c3f4f6f1effd; |
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac tromethamine tablets are indicated for the short term ( 5 days) management of moderately severe Acute Pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS , PRECAUTIONS , DOSAGE AND ADMINISTRATION , and ADVERSE REACTIONS ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days. |
Annotated Indication CUIs: C0184567;C0278140; |
RXCUIs for this Label: IN=35827 SCDF=372547; SCD=834022; |
Similar Labels: 5914ef00-19b1-4e22-9ad3-2b62b455af9d; |
Diltiazem hydrochloride injection is indicated for the following Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in Atrial Fibrillation or Atrial Flutter. It should not be used in patients with Atrial Fibrillation or Atrial Flutter associated with an accessory bypass tract such as in Wolff Parkinson White (WPW) syndrome or short PR syndrome. Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available. In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it is generally short lived, but may last from 1 to 3 hours. A 24 hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent. In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection. In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose. Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection. |
Annotated Indication CUIs: C0242514;C0039232;C0004238;C0004239;C0030590;C0030590;C0030590;C0003811;C0004238;C0004239;C1281999; |
RXCUIs for this Label: IN=3443 SCDF=376886; SCD=833222; |
Similar Labels: 16478b3d-501b-481d-a2a0-8393df6273c3;232cfe02-88f7-45e1-adbf-571ba7ebf650;39010b9b-d240-4891-9d35-f804e7fe2857;445a4720-bb65-4146-90c7-a49fb14a2c74;453b73bd-c52d-4d72-a0b3-47588e723e0b;5e36488b-8f2d-4dc9-b803-af1829e6fdd0;875d1ed5-74b7-4494-ccad-96d2eec23c5a;bba03666-ff4f-4bf6-fa92-78e1ec2d9073;c095d1a1-e31c-4c9e-bafd-e1407c210aaa; |
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure. |
Annotated Indication CUIs: C0085580; |
RXCUIs for this Label: IN=5470 SCDF=370632; SCD=966571; |
Similar Labels: 04b4c1c2-093c-4f48-a6b4-3e290fae51b4;17210abc-58f6-442e-8ff2-7971333c82f6;218c002d-283b-4008-bc38-365cfd53830d;40231804-35ea-4f3f-9a0c-33929f9d8ed1;43ce0ecb-6d62-44bf-8539-823ae03eb9f4;4924a3a0-58c6-4f28-8e72-8a4fc6de055c;c3797028-c625-4f70-ae69-8a5f6f23f1b8;e31239e0-8c5a-4d10-9404-af32278484a3;f34904dc-c945-4de4-8594-34e4f4ac1983; |
Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. |
Annotated Indication CUIs: C0002962;C0699826;C0010073; |
RXCUIs for this Label: IN=3443 SCDF=371856; SCD=831054; |
Similar Labels: 026ee806-ba22-45d5-b0ef-ab382bb3d219;08883bd8-34f2-42af-b567-cd76b057f553;1bb603e2-bdb1-441e-9b64-40046dff7a5e;1df1a585-bf69-44a1-ae78-0994f807c736;22b680aa-d888-47e0-b88f-ec6484f96157;2ff06b26-430d-4710-99ee-1f060079cc58;400f14ec-3af3-434a-bc40-65cf0c902678;461fe23f-4453-4e3f-9621-0e3fda057d14;5443ea50-d4f6-4a75-8c8d-f6dd6978d45e;69ca7cae-fdf3-413a-900b-95cf6e9e7b63;d4ee32b2-1608-4db3-a0db-399c0314edb8;da1c1a8e-c9dd-4c20-b061-638f2d0cecda;dfc6784a-896b-49a8-b72e-83239fa4b388;dfd30506-59e5-4578-879e-fbd6fdd90515;f3e7ecef-f360-4987-a4f5-933214130ab2; |
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease. |
Annotated Indication CUIs: C0006266;C0600260; |
RXCUIs for this Label: IN=435 SCDF=370542; SCD=197316;197318; |
Similar Labels: 1bb952b7-8826-40a1-ac7b-38ec1bd9b94e;2ce4fa42-c406-40fe-a4ff-e5b2b2a17780;5a56892b-7485-4570-9a1d-53ef23f07cbe;87b8cd3c-2849-4b50-b63e-9ea379165c07;953ab65b-b157-41b3-8f90-98fa9d7f20c5;A4663CBB-0265-482A-8BA0-DD6F703E0965;A78ED96A-BE70-497D-BD65-CB0D797969A3;A8454E30-AAE5-43AC-9184-953406E0F3B8;f248b57a-2c06-4ed8-817e-e6ff42f5ce88; |
Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [ see Clinical Studies (14) ] . |
Annotated Indication CUIs: C0917801; |
RXCUIs for this Label: IN=3638 SCDF=375040; SCD=966787;966793; |
Similar Labels: 1bec1223-5239-4eb6-a9e8-62444106d2c0; |
Olanzapine for Injection Agitation Associated with Schizophrenia and Bipolar I Mania Olanzapine for Injection is indicated for the treatment of acute Agitation associated with Schizophrenia and bipolar I Mania. Efficacy was demonstrated in 3 short term (24 hours of IM treatment) placebo controlled trials in agitated adult inpatients with Schizophrenia or bipolar I disorder (manic or mixed episodes) [see CLINICAL STUDIES ( 14.3 ) ]. Psychomotor agitation is defined in DSM IV as excessive motor activity associated with a feeling of inner tension. Patients experiencing Agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the Agitation. |
Annotated Indication CUIs: C0349208;C0085631;C0338831;C0036341;C0853193; |
RXCUIs for this Label: IN=61381 SCDF=485967; SCD=485968; |
Similar Labels: 1e9666ef-4271-4834-8496-ccb3125d83db; |
SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. |
Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=35827 SCDF=992419; SCD=992420; |
Similar Labels: 265a485e-0641-463d-b163-9fcb32cf0d7f;cc9e8fbc-ba36-444c-a61b-38dc4fd856b2; |
ACUVAIL ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery. |
Annotated Indication CUIs: C0021368;C0030193; |
RXCUIs for this Label: IN=35827 SCDF=377446; SCD=858364; |
Similar Labels: 3cea5803-a446-4d2c-9747-f3fb034332c8; |
Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. |
Annotated Indication CUIs: C0266929; |
RXCUIs for this Label: IN=3640 SCDF=371966; SCD=283535; |
Similar Labels: 41b98a75-77e8-46a9-aab4-65908f49f984;bff3f426-44fc-4dbf-96df-df44011103e8; |
DILAUDID HP is indicated for the relief of moderate to severe pain in opioid tolerant patients who require larger than usual doses of opioids to provide adequate pain relief. Because DILAUDID HP contains 10 mg of hydromorphone hydrochloride per mL, a smaller injection volume can be used than with other parenteral opioid formulations. Discomfort associated with the intramuscular or subcutaneous injection of an unusually large volume of solution can therefore be avoided. |
Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=3423 SCDF=370652; SCD=897663; |
Similar Labels: 3832ede8-d3fc-455d-ecab-3b77be5869f5;4d33b072-0755-4b8c-9558-2551306756a3;EE91667E-B636-43CE-5796-3A9E738557A3;f0b78db9-a38c-41bb-8233-5e93f7f18c5c;f68235ab-a367-4604-986c-04e55f1181da;fc55530f-f7d5-4835-96aa-609314b0c6fc; |
ATRIDOX is indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing. |
Annotated Indication CUIs: C0266929; |
RXCUIs for this Label: IN=3640 SCDF=797279; SCD=1113433; |
Similar Labels: 2c718fc7-2921-4d02-b273-784e513f8299; |
Glyburide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non insulin dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone. Glyburide may be used concomitantly with metformin when diet and glyburide or diet and metformin alone do not result in adequate glycemic control (see metformin insert). In initiating treatment for non insulin dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glyburide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short term administration of glyburide. During maintenance programs, glyburide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgment should be based on regular clinical and laboratory evaluations. In considering the use of glyburide in asymptomatic patients, it should be recognized that controlling blood glucose in non insulin dependent diabetes has not been definitely established to be effective in preventing the long term cardiovascular or neural complications of diabetes. |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=4815 SCDF=372333; SCD=197737;310534;310537; |
Similar Labels: 03542333-a884-42dc-960f-75198f18eafd;1c5c56eb-44ef-4dc0-a689-86088d7a5cbf;2D367E16-FC74-4A63-AC6D-85E038164DE5;CA26071D-1FF4-4000-8104-17F211CC6B71; |
Virt PN DHA is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation. |
Annotated Indication CUIs: C0162429; |
RXCUIs for this Label: IN=4511 SCDF=619037; SCD=107078; |
Similar Labels: cd937378-0fba-4cf2-a638-833112e99788; |
CARDURA XL (doxazosin mesylate extended release tablets) is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CARDURA XL is not indicated for the treatment of hypertension. |
Annotated Indication CUIs: C0005001; |
RXCUIs for this Label: IN=49276 SCDF=393431; SCD=636360;636361; |
Similar Labels: cfbb4ddc-00e9-403e-8529-41eb96b81618; |
PRUDOXIN Cream is indicated for the short term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION. ) |
Annotated Indication CUIs: C0011615;C0149922;C0033774; |
RXCUIs for this Label: IN=3638 SCDF=377691; SCD=1000091; |
Similar Labels: 64311378-2da2-4835-a222-5df5204c59c2;d83f9f24-584f-4a30-88c6-1a6f8f9f878a;e3a51eb8-cb8b-498f-bf3e-e464cc4acdca; |
Therapy with lipid altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Prevention of Cardiovascular Disease In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets, USP are indicated to
Hyperlipidemia Pravastatin sodium tablets, USP are indicated
Limitations of Use Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson TypeI and V). |
Annotated Indication CUIs: C0007222;C0020473;C0027051;C0010068;C0242339;C0020479;C0342879;C0342882; |
RXCUIs for this Label: IN=42463 SCDF=373560; SCD=904458;904467;904475; |
Similar Labels: 00bf4e02-633e-453b-8c3c-fb8b1d829887;187997be-2dbf-40af-885f-16df6ba9ae46;1b00f510-c86d-46f6-b427-311a8fd14955;1d5bce9c-a788-4c52-a69e-c53174b8d061;24b45003-6e3e-4aeb-a091-2da8a9f8d4f8;6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4;70dd0d8a-4b4c-43ec-a179-88c0d5dbc536;84f3e019-fd4c-4208-8246-df771d6e025d;88295e57-9167-48a0-b52f-6ec9cef61109;897ad8b7-921d-eb02-a61c-3419e662a2da;9736d9b1-9dca-36a3-5324-3bbeda537aca;99cc0546-bb2d-751e-edfd-1c15a1182e0c;99e0e848-f8f3-4b42-b880-8fbc42633948;a453647b-16de-4795-a550-4f52eac10a26;b4a580e1-5eef-4400-b4de-0a478d668df3;c216d285-0492-43db-98d4-ce5715df2ee0;ca779f66-4b9d-41da-ad0e-e4f58db9fbac;dcf45e4f-b46e-6fbb-b67a-2ff619ab1780;e0c167a4-d8fe-4797-ac83-4364c4c5f9bb; |
Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis PROTONIX I.V. for Injection is indicated for short term treatment (7 to 10 days) of patients with Gastroesophageal Reflux Disease (GERD) and a history of Erosive Esophagitis. Pathological Hypersecretion Associated with Zollinger Ellison Syndrome PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger Ellison Syndrome or other neoplastic conditions. |
Annotated Indication CUIs: C0267055;C0017168;C0043515; |
RXCUIs for this Label: IN=40790 SCDF=377077; SCD=283669; |
Similar Labels: 3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b;48f4d638-d2a1-47fa-9a81-3acda1b1b1e3;51e4144a-489e-436c-609a-39305f8f56ba; |
Generalized Anxiety Disorder NIRAVAM is indicated for the treatment of Generalized Anxiety Disorder. The efficacy of alprazolam in the treatment of Generalized Anxiety Disorder was demonstrated in 5 short term, placebo controlled trials. [ see Clinical Studies ( 14.1 ) ]. Panic Disorder NIRAVAM is also indicated for the treatment of Panic Disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of Panic Disorder was established in 2 short term, placebo controlled trials. [ see Clinical Studies ( 14.2 ) ]. Demonstrations of the effectiveness of NIRAVAM by systematic clinical study are limited to 4 months in duration for Generalized Anxiety Disorder and 4 to 10 weeks duration for Panic Disorder; however, patients with Panic Disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0270549;C0030319;C0001818; |
RXCUIs for this Label: IN=596 SCDF=485412; SCD=485413;485414;485415;485416; |
Similar Labels: d956367b-fd7d-46fc-9533-38a6e02b0b59;ff1630b4-2044-433c-96bc-0bb4ae8d42a0; |
Major Depressive Disorder Fluoxetine is indicated for the treatment of Major Depressive Disorder. Adult The efficacy of fluoxetine was established in 5 and 6 week trials with depressed adult and geriatric outpatients ( 18 years of age) whose diagnoses corresponded most closely to the DSM III (currently DSM IV) category of Major Depressive Disorder (see CLINICAL TRIALS ). A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms depressed mood, loss of interest in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of fluoxetine in hospitalized depressed patients have not been adequately studied. The efficacy of fluoxetine 20 mg once daily in maintaining a response in Major Depressive Disorder for up to 38 weeks following 12 weeks of open label acute treatment (50 weeks total) was demonstrated in a placebo controlled trial. Pediatric (children and adolescents) The efficacy of fluoxetine in children and adolescents was established in two 8 to 9 week placebo controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM III R or DSM IV category of Major Depressive Disorder (see CLINICAL TRIALS ). The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically. Obsessive Compulsive Disorder Adult Fluoxetine is indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD), as defined in the DSM III R; i.e., the obsessions or compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. The efficacy of fluoxetine was established in 13 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM III R category of OCD (see CLINICAL TRIALS ). OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego dystonic and or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of fluoxetine in long term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Pediatric (children and adolescents) The efficacy of fluoxetine in children and adolescents was established in a 13 week, dose titration, clinical trial in patients with OCD, as defined in DSM IV (see CLINICAL TRIALS ). Bulimia Nervosa Fluoxetine is indicated for the treatment of binge eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine was established in 8 to 16 week trials for adult outpatients with moderate to severe Bulimia Nervosa, i.e., at least three bulimic episodes per week for 6 months (see CLINICAL TRIALS ). The efficacy of fluoxetine 60 mg day in maintaining a response, in patients with bulimia who responded during an 8 week acute treatment phase while taking fluoxetine 60 mg day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo controlled trial (see CLINICAL TRIALS ). Nevertheless, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Panic Disorder Fluoxetine is indicated for the treatment of Panic Disorder, with or without agoraphobia, as defined in DSM IV. Panic Disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and or a significant change in behavior related to the attacks. The efficacy of fluoxetine was established in two 12 week clinical trials in patients whose diagnoses corresponded to the DSM IV category of Panic Disorder (see CLINICAL TRIALS ). Panic Disorder (DSM IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four or more of the following symptoms develop abruptly and reach a peak within 10 minutes 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes. The effectiveness of fluoxetine in long term use, i.e., for more than 12 weeks, has not been established in placebo controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). |
Annotated Indication CUIs: C1269683;C0028768;C0006370;C0030319;C0001818;C0006370;C0042963; |
RXCUIs for this Label: IN=4493 SCDF=372233; SCD=313990; |
Similar Labels: 09120812-5cd3-46b3-ad2f-4712df57f8d0;10a49211-025b-4d63-b60c-fadfd9b731c0;11544DEA-2F5E-1536-584A-5D1F37A99770;142F9B27-65A7-4ADD-BDCC-2468695FEDFF;180A07FD-1F6A-4617-B8E0-F938C65BA273;3195db14-0cae-4b49-9fba-49b869fe92a8;34efe868-f01a-49c7-ab02-9f659b1689f8;4e4d8017-9c1d-41eb-affb-8046e3548be9;50c8f400-8704-45bf-a7c7-696b5d54fefc;F63868AF-7C5B-430A-81E7-2483286936F1;cb8c497a-4c4e-4af7-84d0-04c8c4636630;d82283c9-57b9-483e-8de4-a92cac6d263f;e1171b54-c1a3-4220-bc8a-92f49f270183; |
EXALGO is indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around the clock opioid analgesia for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl hour, 30 mg oral oxycodone day, 8 mg oral hydromorphone day, 25 mg oral oxymorphone day or an equianalgesic dose of another opioid, for a week or longer. Limitations of Use EXALGO is not for use
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Annotated Indication CUIs: C0278140;C0278139; |
RXCUIs for this Label: IN=3423 SCDF=902728; SCD=902729;902736;902741; |
Similar Labels: 22e635cb-98c0-e4f9-6a71-62d7487a0a6c;f26ababe-f6f0-443e-8d91-4d2a174675bc; |
Bronchospasm VENTOLIN HFA is indicated for the treatment or prevention of Bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. Exercise Induced Bronchospasm VENTOLIN HFA is indicated for the prevention of Exercise Induced Bronchospasm in patients 4 years of age and older. |
Annotated Indication CUIs: C0006266;C0015263;C0600260; |
RXCUIs for this Label: IN=435 SCDF=745678; SCD=745679; |
Similar Labels: 22367ff1-5edf-429a-955a-728e42695f60;254422f6-37e0-4dc1-ad3b-b2e20009a7b5;4983a17f-0ea9-4369-9626-6a2ca311210d;58860ee1-5a9d-4422-b9bc-78e8b7958b53;77f24a8c-0a9a-4708-a401-3f56b5d4f2c1;7bdda27b-e123-4f33-87e2-63f33b2b061e;829f381a-7888-4579-a2c5-4359764813c3;8e701d71-1dcb-4b84-bada-84e4f04f5e62;911f605d-5451-49e2-a484-00f619f2012b;938ab43d-bf4c-477f-b918-aabe738d562b;d92c5d6b-ff10-4087-36a2-1cfc464cb967; |
Fluconazole for Oral Suspension is indicated for the treatment of
Fluconazole for Oral Suspension is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti infective therapy should be adjusted accordingly. CLINICAL STUDIES Cryptococcal Meningitis In a multicenter study comparing fluconazole (200 mg day) to amphotericin B (0.3 mg kg day) for treatment of Cryptococcal Meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 11024, and cerebrospinal fluid white blood cell count of less than 20 cells mm 3 . Mortality among high risk patients was 33% and 40% for amphotericin B and fluconazole patients, respectively (p = 0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p = 0.48). Optimal doses and regimens for patients with acute Cryptococcal Meningitis and at high risk for treatment failure remain to be determined. (Saag, et al . N Engl J Med 1992; 32683 9.) Pediatric Studies Oropharyngeal Candidiasis An open label, comparative study of the efficacy and safety of fluconazole (2 to 3 mg kg day) and oral nystatin (400,000 I.U. 4 times daily) in immunocompromised children with Oropharyngeal Candidiasis was conducted. Clinical and mycological response rates were higher in the children treated with fluconazole. Clinical cure at the end of treatment was reported for 86% of fluconazole treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients. * Subjects without follow up cultures for any reason were considered nonevaluable for mycological response. The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving fluconazole and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for fluconazole and 23% for nystatin. |
Annotated Indication CUIs: C0085436;C0553694;C0877445;C0006840;C0153252;C0239295;C0031154;C0032285;C0042029;C0006840;C0085436;C0553694; |
RXCUIs for this Label: IN=4450 SCDF=372209; SCD=310352;310353; |
Similar Labels: 29bd0efa-fb16-4e69-bb96-8f6bcf80b9f7; |
DILAUDID INJECTION is indicated for the management of pain in patients where an opioid analgesic is appropriate. DILAUDID HP INJECTION is indicated for the management of moderate to severe pain in opioid tolerant patients who require higher doses of opioids. |
Annotated Indication CUIs: C0030193;C0278139;C0278140; |
RXCUIs for this Label: IN=3423 SCDF=370652; SCD=897653;897663;897745;897753; |
Similar Labels: c88f81ac-1643-4c08-ae2c-63cbe956db7e; |
ACULAR ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. |
Annotated Indication CUIs: C0021368;C0339164;C0022281; |
RXCUIs for this Label: IN=35827 SCDF=377446; SCD=860107; |
Similar Labels: 22eb1082-edd6-4332-894e-44e76cc38413;3196b192-439c-4a71-a002-358efdd5b6e6;5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad;79e29a86-1b44-4d95-8d84-5a2e8f23ddcf;b5f5bdb5-2a0e-437e-a6da-aa262cdc9b89;c94644d3-7b64-4f3d-a0c7-12c77466a0fc;d9a186ba-74a9-b6d4-1109-1e045ba1763e;e2f53384-6c90-4a9f-aacf-281233581742; |
Major Depressive Disorder Fluoxetine USP is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [ see Clinical Studies (14.1) ] . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re evaluated [ see Dosage and Administration (2.1) ]. |
Annotated Indication CUIs: C1269683; |
RXCUIs for this Label: IN=4493 SCDF=378618; SCD=313995; |
Similar Labels: 887fc670-db67-4cfe-967b-46b38375dae5;e4f90075-0c18-4bb6-a580-70aa2a01642e; |
SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD). The efficacy of fluoxetine in the treatment of PMDD was established in 3 placebo controlled trials ( see CLINICAL TRIALS ). The essential features of PMDD, according to the DSM IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of SARAFEM in long term use, that is, for more than 6 months, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SARAFEM for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0520676; |
RXCUIs for this Label: IN=4493 SCDF=372233; SCD=248642;313990;803293; |
Similar Labels: 116d2452-1f06-438a-8740-b6415aec5f1e;c06f80cf-be99-0b77-ebd7-7a5f1561d4b4;e542de29-b400-4b2e-9d5e-0f7c53091f8c; |
Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. To reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0266929; |
RXCUIs for this Label: IN=3640 SCDF=371966; SCD=283535; |
Similar Labels: 0c7f3ff6-5132-4dc1-be60-5247b5384bc4;22a3c998-7d46-49a5-b202-3ca7989a6078;3105a84b-655e-4940-9d11-4209cdb05d6b;49f82130-6f8a-412c-b625-e75906e74675;6339395b-0125-4b18-8743-894e8a97f11b; |
Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia. |
Annotated Indication CUIs: C0020461; |
RXCUIs for this Label: IN=56512 SCDF=375287; SCD=313072; |
Similar Labels: 905c3ee5-d1a7-4deb-a345-4a42296704fa;dfced9d3-10af-493e-ad30-8034f39616fe; |
Indication ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated. Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established. ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. |
Annotated Indication CUIs: C0035854; |
RXCUIs for this Label: IN=3640 SCDF=378209; SCD=901399; |
Similar Labels: 4e954825-3f60-4dbb-a1be-b146fe1acae4;aa15c93a-ff4c-447a-8a21-96da506d8997; |
ACULAR LS ophthalmic solution is indicated for the reduction of ocular pain and burning stinging following corneal refractive surgery. |
Annotated Indication CUIs: C0151827; |
RXCUIs for this Label: IN=35827 SCDF=377446; SCD=860103; |
Similar Labels: 416e6f6e-796d-6f75-7357-617348657265;4fad0873-f79c-4f07-9fac-5060be6b38fe;6bf40382-faef-dfd0-838b-6e45e853a7c5;947e29c2-a270-48e0-ba96-c7ed676db871;9cc9791b-490b-4f0a-8820-849245240747;f9b4404c-67bc-4c8a-aa75-1d668a6eed16; |
Vasospastic Angina Nifedipine is indicated for the management of Vasospastic Angina confirmed by any of the following criteria 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) Angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of Vasospastic Angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when Angina is refractory to nitrates and or adequate doses of beta blockers. Chronic Stable Angina (Classical Effort Associated Angina) Nifedipine is indicated for the management of Chronic Stable Angina (effort associated Angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and or organic nitrates or who cannot tolerate those agents. In Chronic Stable Angina (effort associated Angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing Angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long term safety in these patients are incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and betablocking agents may be beneficial in patients with Chronic Stable Angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS ). |
Annotated Indication CUIs: C0002962;C0699826;C0002963;C0577698; |
RXCUIs for this Label: IN=7417 SCDF=373067; SCD=198032; |
Similar Labels: 0cc236dc-95fa-49cc-aeb8-6590de157585;0d592c37-b38c-4fb6-a1d3-96531384ae8d;1937ff14-34a2-40b4-3261-7e3f484409fe;1ee3c427-81f4-4bdd-a17b-138553c57369;2d934d80-6d28-415d-8963-bf8d1e4b038c;5733e038-7cb5-434b-aa8e-abb25e6252c9;776ccac6-471d-4c41-8c52-a8e90bd832c5;AC0F6540-07E5-446E-BE46-A82E6F27B1E3;a3daa0fc-7ec3-42c2-91b2-8418331dd0fc;ac0cd4d1-34c1-46b4-ad61-f10d7c0e06c9;e04aa152-b08d-47f7-b976-f8bee4c386db;776ccac6-471d-4c41-8c52-a8e90bd832c5; |
Parkinson's Disease Mirapex (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of MIRAPEX tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's Disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES ). Restless Legs Syndrome MIRAPEX tablets are indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with symptoms of RLS. |
Annotated Indication CUIs: C0030567;C0035258; |
RXCUIs for this Label: IN=746741 SCDF=745021; SCD=859033;859040;859044;859052; |
Similar Labels: 3736d691-e8b9-4fdd-aeca-9e96cf907c51;96a79b8f-a749-4668-96c5-60c487942621;b5504316-3907-444c-b604-ec9a18cdcd6d; |
Sucralfate Suspension is indicated in the short term (up to 8 weeks) treatment of active duodenal ulcer. |
Annotated Indication CUIs: C0013295; |
RXCUIs for this Label: IN=10156 SCDF=373966; SCD=313123; |
Similar Labels: 0bd18d2a-07b3-4155-b08a-bdd0cfd0bd2e;0fb67b1c-b4c0-46f2-8a81-df1510e006aa;23e8fee2-0bdd-466e-8233-17a3e5867956;944fa24b-29dd-479e-8aad-a5fcbde68dfa;ccc083ac-8563-4c32-8bcd-c1b12270b1ad;fa6e4661-1bee-4a64-b982-9d44dbdb8498; |
THYROID tablets are indicated
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Annotated Indication CUIs: C0271789;C0342200;C0018021;C0020676;C0342208;C0007115;C0040137;C0040149;C0677607;C0700502;C0004258;C0027145; |
RXCUIs for this Label: IN=10572 SCDF=374122; SCD=208545;313387;313391; |
Similar Labels: 3b2ef0c1-8caf-f44d-3ab6-2eb2e208ab30;5356920e-4b73-421b-8125-ee417cd67ad3;55aa1982-ed08-4268-90dd-d094a436cedb;7617f4a4-8812-44c4-8386-bc991f4d3a77;82cc78b5-20f2-4a4d-a633-012ed0542c09; |
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] Osteoarthritis (OA) CELEBREX is indicated for relief of the signs and symptoms of OA [ see Clinical Studies (14.1) ] Rheumatoid Arthritis (RA) CELEBREX is indicated for relief of the signs and symptoms of RA [ see Clinical Studies (14.2) ] Juvenile Rheumatoid Arthritis (JRA) CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ] Ankylosing Spondylitis (AS) CELEBREX is indicated for the relief of signs and symptoms of AS [ see Clinical Studies (14.4) ] Acute Pain (AP) CELEBREX is indicated for the management of AP in adults [ see Clinical Studies (14.5) ] Primary Dysmenorrhea (PD) CELEBREX is indicated for the treatment of PD [ see Clinical Studies (14.5) ] |
Annotated Indication CUIs: C0184567;C0038013;C0553662;C0029408;C0149875;C0003873; |
RXCUIs for this Label: IN=140587 SCDF=371343; SCD=205323; |
Similar Labels: 05cf80f2-12a0-46b0-bcb7-1c982ed7bd3e;0e3ae600-374f-4ddb-9454-dae0d8076987;14e50e10-bbe0-4a2c-983a-19bfa79bdef7;22d6020b-a76e-5068-e98c-299310df2898;27e5f619-b249-470b-b506-845d280fd9ba;29712b18-c82e-4397-800f-e2920f406f29;2aea0f50-b823-42ba-ab13-b40168bd55a2;73eb9256-dcda-4eb1-8a6e-700522146f2e;90f074fa-f205-4039-822e-d09049812237;925b0408-2ba4-4d4c-a1cd-ddfa7115234d;a6854053-029c-419f-8c79-8b59a2600fa1;b6bd0101-ebf0-43e8-99bf-21cb032b05d6;b8ad0b63-76cf-4fa8-9326-d4b750f02374;bff7e0aa-0c01-4f6e-89ed-da27cc36706e;e3591a83-fbb4-4679-89f0-ce3a2331ed54;fe09528e-a072-4bc8-84eb-e79ed06cd553; |
CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14) ] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM IV) implies the presence of hyperactive impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM IV characteristics. Need for Comprehensive Treatment Program CONCERTA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms. |
Annotated Indication CUIs: C1263846; |
RXCUIs for this Label: IN=6901 SCDF=372862; SCD=1091155;1091170;1091185;1091210; |
Similar Labels: 034fb7cd-e183-475e-8beb-64fd88facc8f;038ae416-4bd5-411b-bd28-d4f0af5c2ab7;12a36e92-cb00-48d5-8981-89d8cce8c4c6;1a88218c-5b18-4220-8f56-526de1a276cd;2bfb390f-ba99-4d21-8a9e-50fa8ec217c0;2c312c31-3198-4775-91ab-294e0b4b9e7f;ecd88778-0540-4f6f-9bbd-61d42f1a9515;effd952d-ac94-47bb-b107-589a4934dcca;f63155b9-ea71-4a30-be32-37173f87bcbf; |
Because of its life threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), amiodarone HCl is indicated only for the treatment of the following documented, life threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. Recurrent ventricular fibrillation. Recurrent hemodynamically unstable ventricular tachycardia. As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone favorably affects survival. Amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital. |
Annotated Indication CUIs: C0085612;C0042510;C0042514; |
RXCUIs for this Label: IN=703 SCDF=370568; SCD=833528; |
Similar Labels: 080d74e0-a5c0-49b6-83e4-4ee9e81c345f;09a6638c-aefb-4112-b9e6-eae89ea7c247;0e70dd96-53ca-4bc3-ba70-0bd63dd94d5b;108cd13a-b2d1-45a2-a654-650aa88155f4;1aa2d919-37fc-4867-ae2d-f6be26528284;2ebbeed4-0112-4279-a5b7-607ab0b0f8d6;2eceb4d5-0c47-49c3-8263-46f689388efe;3e8db251-e3c5-4fba-be9a-6044a92f0beb;48f8c54d-0d7e-4469-86ca-93221d6c8f7d;51be39a2-9134-402c-95ad-defe47406ff8;57df7b65-7829-4364-894f-ae4c2772c733;7551b0a2-bfbd-4a9e-9348-654724c13a29;7ccd3733-c3af-4a11-8500-0f99194c1472;99991CC3-7271-44FC-91C3-3CAB0BBE7645;a0f63765-a291-486c-b198-68a7f2414b83;aeaa8449-e47e-4173-8f85-37c022fd170f;b41cbcb5-9c5d-4e45-a4f2-952df5f22c00;bac761ca-9467-49d9-b6fc-b57cd27ee5f7;e1a80191-fcb5-4aab-a972-accabe6ae9c7; |
1.1 hypertension Diovan (valsartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. heart failure Diovan is indicated for the treatment of heart failure (NYHA class II IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [ See Clinical Studies (14.2)] Post myocardial infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [ See Clinical Studies (14.3 ) ] |
Annotated Indication CUIs: C0018802;C0020538;C0023212;C0027051;C0242698; |
RXCUIs for this Label: IN=69749 SCDF=378276; SCD=349483; |
Similar Labels: 12084cb5-13db-42ea-b91c-1d361960fba7;7494496c-02fc-4509-ae9e-cbd000fa45a1;8e4382de-df78-4821-b11e-c423442a7ff8;b2608b36-03d1-46b6-9633-88d21306a317;c6488119-6547-4abd-bc15-a809b6107d4f;d73a7aa3-5b5f-4532-9936-752366a2430d; |
MIRAPEX ER tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. |
Annotated Indication CUIs: C0030567; |
RXCUIs for this Label: IN=746741 SCDF=901533; SCD=1114479;1114485;901534;901541;901546;901550;901555; |
Similar Labels: e2902ed1-cfeb-4815-adc3-129c577917a1; |
Prevention of Cardiovascular Disease In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL C, or a family history of early coronary heart disease, LIPITOR is indicated to
Hypercholesterolemia LIPITOR is indicated
After the LDL C goal has been achieved, if the TG is still 200 mg dL, non HDL C (total C minus HDL C) becomes a secondary target of therapy. Non HDL C goals are set 30 mg dL higher than LDL C goals for each risk category. Prior to initiating therapy with LIPITOR, secondary causes for Hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total C, LDL C, HDL C, and TG. For patients with TG <400 mg dL (<4.5 mmol L), LDL C can be estimated using the following equation LDL C = total C (0.20 [TG] + HDL C). For TG levels >400 mg dL (>4.5 mmol L), this equation is less accurate and LDL C concentrations should be determined by ultracentrifugation. LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). The NCEP classification of cholesterol levels in pediatric patients with a familial history of Hypercholesterolemia or premature cardiovascular disease is summarized below |
Annotated Indication CUIs: C0018802;C0007222;C0002962;C0010068;C0027051;C0038454;C0020443;C0242339;C0342881;C0342882;C0020479;C0342879; |
RXCUIs for this Label: IN=83367 SCDF=370621; SCD=259255;617310;617311;617312; |
Similar Labels: 76a76f8e-d7c6-4621-b0a4-d5db0c24f089; |
Tonsillitis and or Pharyngitis MOXATAG is a penicillin class antibacterial indicated for the treatment of Tonsillitis and or Pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 yrs and older. To reduce the development of drug resistant bacteria and maintain the effectiveness of MOXATAG and other antibacterial drugs, MOXATAG should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0031350;C0040425; |
RXCUIs for this Label: IN=723 SCDF=802549; SCD=802550; |
Similar Labels: 35e9aa4c-fd8d-4444-9d1a-62723ba29491;4f1bf9ad-216e-4489-9513-fb7e98173bfe;a6c0e721-2021-4983-a305-49bdf8f135a9; |
Thyroid hormone drugs are indicated
|
Annotated Indication CUIs: C0342200;C0677607;C0018021;C0020676;C0342208;C0040137;C0700502;C0004258;C0018021;C0271789;C0027145; |
RXCUIs for this Label: IN=10814 SCDF=372611; SCD=903456;903697;903703; |
Similar Labels: 0a2215ba-fdc1-4439-b4c5-679933c4a6fb;36a95013-bc64-415b-b429-d5318912df89;51452b31-ff68-4e0c-b982-c15502ebf1d3;55bc9030-d71f-4464-9754-155ee02b1c7c;cfa4a974-3d3a-4772-a2da-1b2383672e0a;d4e23cbd-2e01-46c2-a690-0b87158d7003;e660bf02-07a6-47f2-aace-de51bf6bf844;fb6dbbf8-45fd-4956-9b12-9125474c825d; |
Multiple Myeloma THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed Multiple Myeloma (MM). Erythema Nodosum Leprosum THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe Erythema Nodosum Leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. |
Annotated Indication CUIs: C0343467;C0026764; |
RXCUIs for this Label: IN=10432 SCDF=374072; SCD=200390;360176;360177;700416; |
Similar Labels: 2eda833b-1357-4ed4-a093-194524fcb061; |
Non Hodgkin's Lymphoma (NHL) Rituxan (rituximab) is indicated for the treatment of patients with
Chronic Lymphocytic Leukemia (CLL) Rituxan (rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20 positive CLL. Rheumatoid Arthritis (RA) Rituxan (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis who have had an inadequate response to one or more TNF antagonist therapies. Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) Rituxan (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). Limitations of Use Rituxan is not recommended for use in patients with severe, active infections. |
Annotated Indication CUIs: C0023434;C0521173;C0343192;C0024305;C0264939;C0003873;C0043092; |
RXCUIs for this Label: IN=121191 SCDF=377259; SCD=242435; |
Similar Labels: b172773b-3905-4a1c-ad95-bab4b6126563; |
MOXEZA solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms Aerococcus viridans* Corynebacterium macginleyi* Enterococcus faecalis* Micrococcus luteus* Staphylococcus arlettae* Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus* Staphylococcus warneri* Streptococcus mitis* Streptococcus pneumoniae Streptococcus parasanguinis* Escherichia coli* Haemophilus influenzae Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis * *Efficacy for this organism was studied in fewer than 10 infections. |
Annotated Indication CUIs: C0009768; |
RXCUIs for this Label: IN=139462 SCDF=406106; SCD=403818; |
Similar Labels: 05248b68-16a9-488d-a39f-5137d2410471; |
Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. |
Annotated Indication CUIs: C0035854; |
RXCUIs for this Label: IN=6922 SCDF=378013; SCD=311679; |
Similar Labels: 33a06972-62b7-4131-81da-77ae692b4869;43d5e570-f359-564d-9bb4-51784ad97b6f;43ed872b-63ac-4a22-9c9e-cc0e05bcc41e;4a233572-2471-4e99-a45e-2de978abcf16;537f1a8a-db9a-15f3-4833-56befc31bb10;5f6014f9-4a54-47c6-a290-01472e6c0fe7;818dbe07-0267-4682-b171-5ab022ef9801;85a9ba62-eeb8-419e-a21f-e3db1eda7fc4;86da8d86-5ab2-f668-fdfd-b0e93e6a2245;99eaa138-0cfa-45e1-abbf-a88271707979;ab766931-e685-4a81-9939-06da80d9099e;c4e07c26-245d-3e51-6a47-fccde22334d2;c5e18ef7-8bf7-c100-cd24-c727f03f435c;c7156e83-f344-4e9f-a42d-6dc8ce90a0b9;c860c7ef-c1e1-488b-8236-c87d8421820b;de4cb39f-cc6e-98fb-05e5-103f3aca2dad; |
1.1 hypertension Diovan (valsartan) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan. Control of High Blood Pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan may be used alone or in combination with other antihypertensive agents. heart failure Diovan is indicated for the treatment of heart failure (NYHA class II IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [ See Clinical Studies (14.2)] Post myocardial infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [ See Clinical Studies (14.3 ) ] |
Annotated Indication CUIs: C0020538;C0018802;C0023212;C0027051;C0242698; |
RXCUIs for this Label: IN=69749 SCDF=378276; SCD=349200; |
Similar Labels: 27bee6c9-118a-4609-8949-2eb161b0c5c4;29c0e001-4855-4903-aa1d-64e4dd155b8a;5ddba454-f3e6-43c2-a7a6-58365d297213;7026f0a7-3f08-4116-aa0b-eb61dc3804ab;e80642ad-bb06-4546-ae33-5bc70cf05cee; |
Metronidazole Cream, 1%, is indicated for the topical treatment of inflammatory lesions and erythema of rosacea. |
Annotated Indication CUIs: C0041834;C0035854; |
RXCUIs for this Label: IN=6922 SCDF=377759; SCD=311680; |
Similar Labels: 1787c491-d92c-4239-9d9f-6a91b629835d;C6DBB330-4926-49D3-936D-488975985484; |
MARINOL Capsules is indicated for the treatment of
|
Annotated Indication CUIs: C0003123;C0027497;C0042963; |
RXCUIs for this Label: IN=10402 SCDF=371971; SCD=197635;197636; |
Similar Labels: 08adbfd9-789a-4888-a9e2-2a6dac867885;1f1af798-17d5-47d0-b129-21d4aa1eb125;5050ed63-c6bc-4761-9a81-ef8e5f3f378e;5bbac0b1-ddc2-400b-8e0d-1e1d484720ca;68b4168b-5782-4e68-a25a-5b4e4408dbce;a6269fc3-ca40-444f-8035-d6a391d037e0;fffb4e00-c921-4958-aeab-18deae4a2e38; |
schizophrenia Oral olanzapine is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia two 6 week trials and one maintenance trial. [ see Clinical Studies ( 14.1 )]. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5 , 5.6 ) ]. Information describing the use of olanzapine tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Company s olanzapine drug product labeling. However, due to Eli Lilly and Company s marketing exclusivity rights, this drug product is not labeled with that pediatric information. bipolar I disorder (Manic or Mixed Episodes) Monotherapy Oral olanzapine is indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar I disorder two 3 to 4 week trials and one monotherapy maintenance trial. [see Clinical Studies ( 14.2 ) ]. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5, 5.6 ) ]. Information describing the use of olanzapine tablets in pediatric patients with bipolar I disorder is approved for Eli Lilly and Company s olanzapine drug product labeling. However, due to Eli Lilly and Company s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Adjunctive Therapy to Lithium or Valproate Oral olanzapine is indicated for the treatment of manic or mixed episodes associated with Bipolar I Disorder as an adjunct to lithium or valproate. Efficacy was established in two 6 week clinical trials in adults. The effectiveness of adjunctive therapy for longer term use has not been systematically evaluated in controlled trials [see Clinical Studies (14.2) ]. Special Considerations in Treating Pediatric schizophrenia and Bipolar I Disorder Information on treating pediatric patients with schizophrenia and Bipolar I Disorder is approved for Eli Lilly and Company s olanzapine drug product labeling. However, due to Eli Lilly and Company s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Olanzapine and Fluoxetine in Combination Depressive Episodes Associated with Bipolar I Disorder Oral olanzapine and fluoxetine in combination is indicated for the treatment of depressive episodes associated with Bipolar I Disorder, based on clinical studies in adult patients. When using olanzapine and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. Olanzapine monotheraphy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. |
Annotated Indication CUIs: C0349208;C0853193;C0338831;C0036341;C0853193;C0036341; |
RXCUIs for this Label: IN=61381 SCDF=373142; SCD=200034;312078;312079;314154; |
Similar Labels: 0e986037-41c9-431e-b007-0e7764523fdd;296e29ff-206d-409a-8c0f-10b2ec081be5;2cb1bebe-0ced-46d8-bf21-c28a9acc4a15;30a963ab-b2ee-4949-8c3c-00d0f308dd61;3347d1c8-04c9-5ce1-8cda-b38e0412b709;3989d366-c9a5-476f-9649-213bace07768;4464f13c-b9b9-4464-a05e-5b2cdc091fb2;5f3a9abd-aaca-48b9-8cc9-79bb21179ff5;636665be-9d7e-443a-8134-e8cc47e6ba24;66ef201f-85eb-44f0-9ef0-1b618c6e0bff;676ace4e-7706-742d-cab0-430dd1f83408;709d79a1-2742-4629-af43-161be166833a;71c6577c-ffea-4934-bc10-2d35942f8a16;75616c31-8fed-4014-a9f2-4a028eccd586;7881c39e-0624-4c14-a6c3-7a9dc81c198c;7c6ff491-c30c-4ada-85a0-cbee98f2fe32;7f243027-7047-47c4-8b66-288c60ec2008;7fd4c66a-1535-4651-b01a-42ba69e0a965;842b438f-86c7-44f2-a614-06915757a4dd;96165590-b287-0ed9-3723-752af59aedad;9a57a63e-f856-aafa-037a-c08f2fea6496;a1dfb4e7-4143-4422-b7a7-292e4fd75044;a3c9ea17-3793-494a-8b32-44e48f9f4503;abd4a67a-6334-427b-9ad4-4fafefa49e51;aff02cff-d079-bc82-6182-a24c4c6e09a6;c0d705bf-b719-4c7b-b83d-c17d41cbbfad;d5051fbc-846b-4946-82df-341fb1216341;d6a92eba-0841-474b-96f3-778f060ab133;d974d2a4-fc65-42ff-8138-cfcfd7381534;d976599a-0ee0-4fa4-afe6-bdfbca570afe;dd0b2525-4e2f-44fc-9302-0ae4ebb1e135;e24a692e-0dd5-4637-bb3b-bca2538870da;f6ec3e3e-24c3-4360-b712-ca6017af1347; |
Parkinson's Disease REQUIP XL (ropinirole extended release tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's Disease. |
Annotated Indication CUIs: C0030567; |
RXCUIs for this Label: IN=72302 SCDF=799053; SCD=799055; |
Similar Labels: 1e565a1d-8886-437b-8e61-031455732a5c;2deb758c-659e-4e5a-a087-0e9c422f2fe1;2ed1aae8-ca68-41f7-8922-3662329117c4;6c24b96c-7d8d-494a-b7cd-49fe6138a66d;a402c1d1-8841-faa9-e9b9-d490fc6353bd;c1859eee-b5b9-401e-34ac-254a30218555;cedabd80-c526-409a-b1fb-f46de085a3db;ec0612a1-ccb1-bb51-8881-04faf491e093; |
Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema. |
Annotated Indication CUIs: C0004096;C0006277;C0006266;C0013990; |
RXCUIs for this Label: IN=10368 SCDF=374040; SCD=857677;857683; |
Similar Labels: 2cc059f3-de3a-4ccd-93a3-2850828b1acb;352e3476-2bc4-4995-9fd9-4a8864417f1a;382dcebb-6e41-4335-818d-b5822e3fb884;4ae8fb3d-9df3-4948-bb07-6e4169521f15;586cbc83-85d1-cd0f-d4a2-39b20dbcc82f;613df3cb-4d55-4d12-ab08-a932481aaa0b;879be756-991a-42c5-a381-9c8c2ad1fbdb;8a15f833-8817-48e0-9372-b876865e3b92;a89dcda2-2633-4c63-a6fe-d6d7bf0cdf32;cec31032-f366-4524-9e01-63146e473b2b;e691d5be-50b3-4076-be83-d18efd9489cb;ed2af9a9-8bc4-4c6a-b8df-e8fc88c93d6c;fbf54709-5857-4dbc-9233-ebd7abff88c8; |
Triostat (liothyronine sodium injection) (T 3 ) is indicated in the treatment of myxedema coma precoma. Triostat can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef. |
Annotated Indication CUIs: C0238298; |
RXCUIs for this Label: IN=10814 SCDF=377133; SCD=903694; |
Similar Labels: 4cd4baf4-18d2-434f-b80b-4f4b19996cf9;a8b39730-de19-497d-bde8-6594aa528403; |
ARICEPT is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer's Disease, as well as in patients with severe Alzheimer's Disease. |
Annotated Indication CUIs: C0002395; |
RXCUIs for this Label: IN=135447 SCDF=483071; SCD=997216; |
Similar Labels: 2B1B7B5F-2F20-418C-B1AC-794C2EF1CE5E; |
Metformin HCL Tablets as monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin HCL is indicated in patients 10 years of age and older. Metformin HCL may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older). |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=6809 SCDF=372803; SCD=861007; |
Similar Labels: 3aa936a1-1ce2-4725-8e18-2d3636b187d9;468AF59B-81E9-4876-9903-EACAECD28B3B;553777EE-8ECA-4A89-89B7-317A3E9084F6;72a8a091-97bf-4df3-a196-e83e4add8fc6;9d896352-3611-4161-b7b7-826eaf8288c0;A3878E6A-ABB9-4994-8D5A-EA4DC2E85226;A57FD3FC-4C8F-4EB4-8BE0-9C7E243624BC;A757F9F8-A925-4E47-9B83-131CCCF8E470;BF1B5EE0-ED51-45E8-9ACD-D5468B51679F;e17d7cc3-e193-4f41-a457-4b6b32a9201d; |
HALCION is indicated for the short term treatment of insomnia (generally 7 10 days). Use for more than 2 3 weeks requires complete reevaluation of the patient (see WARNINGS ). Prescriptions for HALCION should be written for short term use (7 10 days) and it should not be prescribed in quantities exceeding a 1 month supply. |
Annotated Indication CUIs: C0917801; |
RXCUIs for this Label: IN=10767 SCDF=374197; SCD=198317;198318; |
Similar Labels: 0cdd2d17-92fa-4534-a1d3-d47733fbb6d8;12c0c495-a032-382e-9b04-37018090cad0;3aa63f5c-2490-4bce-bc5e-35331d5d51ad;5add318e-11b9-42f8-b052-0d8cebb32fcf;6D743386-A8E4-4A3F-AC82-C046896F35AE;73db8a0e-02a9-4613-8feb-e847c965d34f;9bf087eb-daeb-41f7-80b5-5fc70927011d;a0da0dba-a56d-486b-a45b-e8a7cdfbeac6;aef73b7b-c72b-4775-abd6-8f0144cfb14d;b130a3b2-e34a-411f-b3d8-121ae81c98e0;db1311ad-9732-4fdb-80dc-95b09077e3d0;db564864-17fc-4ba5-a438-a467ef57a0ca; |
AVELOX Tablets and I.V. are indicated for the treatment of adults ( 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION for specific recommendations. In addition, for I.V. use, see PRECAUTIONS, Geriatric Use .) Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae , or Moraxella catarrhalis . Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin susceptible Staphylococcus aureus, or Moraxella catarrhalis. Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae . * MDRSP, Multi drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin resistant pneumoniae ), and are strains resistant to two or more of the following antibiotics penicillin (MIC 2 g mL), 2 nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim sulfamethoxazole. Uncomplicated Skin and Skin Structure Infections caused by methicillin susceptible Staphylococcus aureus or Streptococcus pyogenes . Complicated Intra Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species . Complicated Skin and Skin Structure Infections caused by methicillin susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae (See Clinical Studies ). Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. To reduce the development of drug resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0275556;C0008677;C0694549;C1112209;C0037278;C0000833;C0275524; |
RXCUIs for this Label: IN=139462 SCDF=374619; SCD=311787; |
Similar Labels: 222e661d-e956-441a-a02b-b70e0f05c328;3a680766-06c8-4643-94c1-0f1bba5cdd8c;56b4f979-bf20-4908-9d7c-5536221d77f8;69deea75-b24f-4d4c-8150-2404a23ef618;be8e0025-5726-4965-9510-e7e657687d23;fe9226f8-64f4-4eff-8339-ed3fce0896f2; |
Asthma SINGULAIR Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Copyright 1998 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved is indicated for the prophylaxis and chronic treatment of Asthma in adults and pediatric patients 12 months of age and older. Exercise Induced Bronchoconstriction SINGULAIR is indicated for prevention of exercise induced bronchoconstriction (EIB) in patients 15 years of age and older. Allergic Rhinitis SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. |
Annotated Indication CUIs: C2607914;C0004096;C0035457;C0018621;C0015263; |
RXCUIs for this Label: IN=88249 SCDF=374624;378682; SCD=200224;242438; |
Similar Labels: 10cd5ca5-6f8b-417c-af11-a2054a2dde34;1525056d-c2c2-4956-9ed5-2d925bff459b;34eee405-05c1-449a-a06f-ca676056c665;78eea56d-15a6-4ceb-b755-d1a3e9707f32;8c166755-7711-4df9-d689-8836a1a70885;99c5d8c4-92d6-41b3-9caa-777fce558261;a99f55de-39d1-483a-ba88-dbda5613c6a7;d7434c6c-5a26-46e0-bade-0c54d71112fc;e8d9021d-73aa-4c96-8b8a-e90069e78555; |
DOLOPHINE is indicated for the
DOLOPHINE is not for use
Code of Federal Regulations, Title 42, Sec 8 Methadone products when used for the treatment of opioid Addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment. Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program. Regulatory Exceptions To The General Requirement For Certification To Provide Opioid Agonist Treatment During inpatient care, when the patient was admitted for any condition other than concurrent opioid Addiction (pursuant to 21CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis). During an emergency period of no longer than 3 days while definitive care for the Addiction is being sought in an appropriately licensed facility (pursuant to 21CFR 1306.07(b)). |
Annotated Indication CUIs: C0085281;C0278140;C0278139; |
RXCUIs for this Label: IN=6813 SCDF=372808; SCD=864706;864718; |
Similar Labels: 6059a68d-5434-4a0e-9f53-b793c3dc8630;7a4840d6-98e3-4523-81a0-ef0b3a47d0c2;802ab399-479b-4271-a2a7-07aadde91cff;d0e6a966-179a-45e0-8444-4c1b8523f8d2;d3b7a707-78af-4fd5-9b66-b63050bbd6f6;eddf7077-02fb-4771-9823-31984f4ff2bb; |
VANDAZOLE is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non pregnant women. |
Annotated Indication CUIs: C0085166;C0042267;C1622505; |
RXCUIs for this Label: IN=6922 SCDF=379122; SCD=142046; |
Similar Labels: 27d71471-8f89-4a1e-8c55-020a58961454;fcf35c8b-b5a5-4806-827f-148cd3c8d3e5; |
Metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. CLINICAL STUDIES A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which metronidazole topical lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. Metronidazole topical lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigator's global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table |
Annotated Indication CUIs: C0035854; |
RXCUIs for this Label: IN=6922 SCDF=377760; SCD=242736; |
Similar Labels: 5368755a-dd37-4e34-843f-ece6bac8ef6a;970a767a-7a65-4cdf-84fe-4dbe0a77b80a; |
Treatment of Anaerobic Infections Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. Metronidazole is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. Intra abdominal Infections, including peritonitis, intra abdominal abscess and liver abscess, caused by Bacteroides species including the fragilis group fragilis, B. distasonis, B. ovatus, thetaiotaomicron, B. vulgatus). Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. Skin and Skin Structure Infections caused by Bacteroides species including fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species. Gynecologic Infections, including endometritis, endomyometritis, tubo ovarian abscess, and post surgical vaginal cuff infection, caused by Bacteroides species including the fragilis group, Clostridium species, Peptococcus species and Peptostreptococcus species. Bacterial Septicemia caused by Bacteroides species including the fragilis group and Clostridium species. Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the fragilis group. Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the fragilis group. Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the fragilis group. Endocarditis caused by Bacteroides species including the fragilis group. Prophylaxis The prophylactic administration of Metronidazole Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing selective colorectal surgery which is classified as contaminated or potentially contaminated. Prophylactic use of Metronidazole Injection, USP should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see DOSAGE AND ADMINISTRATION ). To reduce the development of drug resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0004669;C0404521;C0684256;C0014118;C1112209;C0149725;C0037278;C0041343;C0006105;C0014009;C0014179;C0269050;C0023885;C0024110;C0025289;C0031154;C0032285;C0392618;C0243001;C0007684; |
RXCUIs for this Label: IN=6922 SCDF=376657; SCD=311683; |
Similar Labels: 21f92715-5550-4181-a170-e715c3c9e5b3;25ef25b3-477b-40a4-afc3-04d2333ce709;291a45f6-ed27-4dcc-8364-358d08623797;3193a61d-acc4-445a-8bb9-328568d43937;31999703-3b31-4820-9319-1e5675c1ad82;3908517e-eb15-42a9-b651-fb2ec625e11b;394e0a80-4fb6-425c-b614-52c118db769e;3dc5f411-3312-4add-8198-161eed98132b;504ee940-05e5-457d-95d2-311d5e0f5fff;50f37ffb-81e3-43a1-9ff7-a1d23b5cfcd5;6b35138f-491b-46cf-97d3-55f43e651d63;6d969bc3-8182-4b4b-862e-3fb6a5cfc04f;8df92539-5acf-46b1-b7e2-e9fac21b30ae;9db2ddc3-8193-4efc-bd39-f532ccec47c5;A66ABF44-9AE9-4342-B69A-EBAA1F9B7D78;A9987047-9C99-45A5-829B-AE8B189CBFD4;a2883ca1-5a9a-4259-9d80-46ab67274384;a775da83-6554-4229-afb8-92cdcfb4503e;b3027944-1c31-46fe-a9fa-1fea55f8171b;b39cc0e4-57ad-4d70-a105-44ebccf201f8;b5349a88-9275-489e-8c71-2bd22eb9e520;b989cb92-dbe5-4325-bcd3-43fe8a5f13b7;c49de241-088a-4ac1-ae9e-bab7a8b22417;c9fc6a64-cd68-46bd-a470-843b5d44eb2b;d2112f37-5080-4a19-bcc3-6386b49abe1d;d552db0a-959c-4ad9-ab65-d7cc541baf7e;d7b3d7f0-ea9c-45fd-9aa9-699ed93ac11a;e1e7e127-e99e-80e9-1606-71261658b0c1;ecf64245-20b1-4bff-9fcc-b8a16905e27b;efb2f572-1e11-43e3-a653-eaeafc17ec79;eff2f83e-d2b0-4ff5-afbd-76b45763af93;f0a90f3c-a6c2-4e84-af9d-6f0470bce59b;f3505fef-f135-4b1f-b743-846342625a79;fb79c214-e6ff-499a-9e23-a759bef9b7cb;fd191c06-9d3b-4e46-9f79-90f6af614947;fe23dfcf-cb33-4363-9b0a-c3a4d1d7d6de; |
Healing of Erosive or Ulcerative GERD ACIPHEX is indicated for short term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8 week course of ACIPHEX may be considered. Maintenance of Healing of Erosive or Ulcerative GERD ACIPHEX is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months. Treatment of Symptomatic GERD ACIPHEX is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults and adolescents 12 years of age and above. Healing of Duodenal Ulcers ACIPHEX is indicated for short term (up to four weeks) treatment in the healing and symptomatic relief of Duodenal Ulcers. Most patients heal within four weeks. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ACIPHEX in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate pylori . Eradication of pylori has been shown to reduce the risk of Duodenal Ulcer recurrence. {See CLINICAL STUDIES ( 14.5 ) and DOSAGE AND ADMINISTRATION ( 2.5 )}. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. {See CLINICAL PHARMACOLOGY, Microbiology ( 12.2 ) and the clarithromycin package insert, CLINICAL PHARMACOLOGY, Microbiology .} Treatment of Pathological Hypersecretory Conditions, Including Zollinger Ellison Syndrome ACIPHEX is indicated for the long term treatment of pathological hypersecretory conditions, including Zollinger Ellison syndrome. |
Annotated Indication CUIs: C0013295;C0017168;C0018834;C0079487;C0043515; |
RXCUIs for this Label: IN=114979 SCDF=375256; SCD=854868; |
Similar Labels: 0eed7378-67a4-4b08-aeea-32471ce2028e;52459f70-e1f5-41bb-a9f4-e68ef5f5dcf5;5d103551-978f-472a-9c62-51e6e4dea068;6e6f6c6d-4826-4817-90ff-5c3f4fbe8909;dbfa7ae4-35af-4ed3-bca4-7900cd92047c; |
Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculo skeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man. |
Annotated Indication CUIs: C0184567; |
RXCUIs for this Label: IN=7715 SCDF=373156; SCD=994541; |
Similar Labels: 56bc8e4a-6771-476d-95e8-e4ef2d869cb2;aec8ad3a-f717-4e74-b7b9-19debdaad79a; |
For detoxification treatment of opioid addiction (heroin or other morphine like drugs). For maintenance treatment of opioid addiction (heroin or other morphine like drugs), in conjunction with appropriate social and medical services. |
Annotated Indication CUIs: C0085281; |
RXCUIs for this Label: IN=6813 SCDF=853462; SCD=864978; |
Similar Labels: 552751F7-42FF-40C7-8495-A6AA306D5C23;808a9d0b-720b-4034-a862-5122ff514608;e6af84de-cbfc-4a3b-bd73-6bcf77337168;e72841bf-364b-49b1-8e69-7e26ddcd2657; |
VIGAMOX solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms Aerobic Gram positive microorganisms Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Aerobic Gram negative microorganisms Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae * Other microorganisms Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. |
Annotated Indication CUIs: C0009768; |
RXCUIs for this Label: IN=139462 SCDF=406106; SCD=403818; |
Similar Labels: 68cca7e1-120c-4ac6-8851-15a17e11bd9f; |
METROGEL VAGINAL is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans , and Herpes simplex virus should be ruled out. |
Annotated Indication CUIs: C0085166;C0042267;C1622505; |
RXCUIs for this Label: IN=6922 SCDF=379122; SCD=142046; |
Similar Labels: 150384e6-1f49-4e79-9c44-b704778ecb65;1e48a661-d836-4f79-a07b-fdbffb35dcfc;8f974c5f-6b14-214e-f551-d096c332648d;918f50d4-5468-400e-b51f-72ac883af46e;94688946-19f1-4f46-903a-2e9c9b89b0f5;bd3b62b6-4a80-495b-a1d3-d54eb15baf79;d36b7894-2152-452d-9bba-38067c52c79e; |
GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use GLUMETZA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=6809 SCDF=372804; SCD=860975;860996; |
Similar Labels: 4383c6ec-53ad-4c79-b0af-316b3284b2fb;fb832474-88d9-4e29-95cd-fbc446944cc4; |
Bacterial Vaginosis (BV) Flagyl ER 750 mg tablets are indicated in the treatment of women with BV. To reduce the development of drug resistant bacteria and maintain the effectiveness of Flagyl ER and other antibacterial drugs, Flagyl ER should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0085166; |
RXCUIs for this Label: IN=6922 SCDF=372898; SCD=636559; |
Similar Labels: 0b0ba593-fe54-456c-a3d7-651c50036e3e; |
Dyrenium (triamterene) is indicated in the treatment of Edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid induced Edema, idiopathic edema and Edema due to secondary hyperaldosteronism. Dyrenium may be used alone or with other diuretics, either for its added diuretic effect or its potassium sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. Usage in Pregnancy . The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy (however, see PRECAUTIONS below) when Edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent Edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with Edema, including generalized edema, in the majority of pregnant women. If this Edema produces discomfort, increased recumbency will often provide relief. In rare instances, this Edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. |
Annotated Indication CUIs: C0013604;C0023890;C0018802;C0238094;C0027726;C0271728; |
RXCUIs for this Label: IN=10763 SCDF=374193; SCD=198312;198313; |
Similar Labels: 5012f997-9fb2-4c3d-99fd-4f7efd7c39af; |
Treatment of Influenza TAMIFLU is indicated for the treatment of uncomplicated acute illness due to Influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days. Prophylaxis of Influenza TAMIFLU is indicated for the prophylaxis of Influenza in patients 1 year and older. Limitations of Use The following points should be considered before initiating treatment or prophylaxis with TAMIFLU
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Annotated Indication CUIs: C0021400; |
RXCUIs for this Label: IN=260101 SCDF=374615; SCD=312122; |
Similar Labels: 03a2a7f0-406c-4784-84c1-5fd5f5be4773;1948cafd-b5b3-4212-9d5d-8c293b1baad5;644ddc43-b2fa-44bd-aeb7-2547defb85e0;ca868d3d-177d-42c4-b05b-7beae7343b53;ee3c9555-60f2-4f82-a760-11983c86e97b; |
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short term relief of the symptoms of Anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved Anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association s Diagnostic and Statistical Manual, III 1 as follows Generalized, persistent Anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories
The effectiveness of buspirone in long term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long term use, 264 patients were treated with buspirone for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0003469;C0270549;C0086132; |
RXCUIs for this Label: IN=1827 SCDF=371164; SCD=866018;866083;866094; |
Similar Labels: 0053914d-6a91-405c-879d-96015aed4ad7;0568f0c0-2f05-374d-11bf-c74796629535;0eefdd8d-7745-47ae-a204-f35687f3db11;123ce8fe-2eb7-4bd0-8e9b-d468135c4497;19a92a99-f73a-42f5-b048-28ba0b4df9e6;1bbebece-7102-4a4e-8efd-69a8e333d084;239dcefe-45a9-48f5-a6f1-1ac6546e0da2;2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd;337ba17d-bfc5-40d8-9c57-978fe38d842f;4b044819-2959-4914-b564-d944201246fd;556e1e60-a6f3-4244-8ea8-881846ba7a9b;67f176cd-cddf-4c04-970f-ba5e7e00f787;6fac36b4-b223-479e-913f-f8c9cdb9e119;72bff09c-826e-4394-a7e7-41d56ce9605b;7c9eafb9-9ce1-4b28-900c-8fcb4b23424e;7e79a157-c89d-4215-af29-5ff4d823cb47;8351a3c5-e06e-4d27-a504-f36e0b22d41f;8ed30856-84d2-dd2b-04d4-b101f6030bc0;91bb5fc9-5121-43c2-b2af-149240d4189a;a3fe0ccd-565f-4d0a-a7ba-2fad7a819358;aca8b358-d172-43d6-95bb-8064b8ed680c;ae450460-d5e2-4bc9-8a22-eee0018b3c69;b150e196-4af1-4f56-abce-0324d322c082;b3240f73-c506-4591-a441-3bfab2fb1281;b534c251-f15c-4831-96b8-d496fd916c23;b971e151-4a68-4c01-8f9b-8c56f6bad18a;bbf2015c-0093-4e53-b25e-33f5d2987a7a;c78cf4ff-51b2-851e-89cc-98ea543e3865;e57280e0-8ab1-49a6-852c-bc45596028fa;f35ec9aa-2be6-40c9-9112-b9e3b80f8fa8; |
Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ). |
Annotated Indication CUIs: C0006826;C0027796;C0278140; |
RXCUIs for this Label: IN=2599 SCDF=371582; SCD=884221;884225; |
Similar Labels: 2a5b46ec-4c16-48a5-9e58-8d28a3f21274;34a3d45b-0300-4a93-ba4c-ec3cef584023;6e562c90-2e37-47ac-9c3f-12460f96dc33;8c126bb8-732a-4949-8754-2f50b5543638;bd44ea11-0650-4f9e-8663-b9be5f7bcd8d;c60f781a-ad68-419a-8f87-137664f2bb43;f6798f73-b5a6-434b-a627-aa102b123dd5; |
Predialysis Patients Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of 100 pg mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical Hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. |
Annotated Indication CUIs: C0020626;C0022661;C0020598;C0342342;C0005944;C0029405;C0033806;C0020503; |
RXCUIs for this Label: IN=1894 SCDF=371189;371190; SCD=308867;308868;313932; |
Similar Labels: 3289b482-8733-484d-b1db-d7f4cdcd1ac2;517f23e8-4ad5-46e7-8dc4-473d5dcb09c8;66a69351-5b09-4368-a9fa-acf81b5ad882;84262b69-df29-41d0-9e97-6e1188096aeb;DC293A1C-995D-40FA-AC99-68DF12EB6D9E;ae2d0165-1b19-4406-9f28-f4b1579c3dbf;cdcaffc6-e14e-4607-b77b-fc78a8382f60;d1013494-bf62-4e68-9f0c-e6571137f20f;d3d69786-ac48-4a71-bbd8-83172e86d577;e26e13c4-7e45-4e66-8c0d-7fc68e24cdd5; |
CLEOCIN Vaginal Cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). CLEOCIN Vaginal Cream 2%, can be used to treat non pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES .) NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans , and Herpes simplex virus should be ruled out. |
Annotated Indication CUIs: C0085166;C0042267; |
RXCUIs for this Label: IN=2582 SCDF=377651; SCD=309337; |
Similar Labels: 1e0abbaa-81eb-47a2-ad25-9512c4386a45;3db26227-208d-4fdd-8426-1d9be5cda9b4;706dd0b6-367c-4950-88fe-7a6c0661c2b9;997a23c8-f0d7-49d5-af33-e11f2ddab3c7;b52bdaf7-3b54-4165-9ab0-9dfa08170e47;d952e542-d040-42ec-b40e-198195bfe8d0;dfa15be0-7f3b-4cc5-90b4-9471851af410;f9be442d-0782-4b93-828f-9ebbf67dbced; |
Indication VECTICAL Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older. Limitations of Use VECTICAL Ointment should not be applied to the eyes, lips, or facial skin. |
Annotated Indication CUIs: C0406317; |
RXCUIs for this Label: IN=1894 SCDF=393343; SCD=388517; |
Similar Labels: 7fa4ab07-3d8e-4300-91f3-b1e17cba8691;a1567da9-af74-4afd-9ac5-8b53ec5d7cbf; |
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. |
Annotated Indication CUIs: C0005697;C0080274; |
RXCUIs for this Label: IN=19257 SCDF=371067; SCD=857321;857328;857336;857340; |
Similar Labels: 138ed3d0-57db-4df1-8124-06033ecc76f0;5513ddc8-90c8-4548-8188-5a807465cdc4;6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e2;770ccafd-2b4f-46e1-807c-55f9925657e9;80393410-dd51-4cac-b27c-50ece00cca37;80ee6156-18b8-45aa-9402-b40647173da8;8693204e-3bb5-4ada-93a4-eda563615db9;CB6A43E9-5663-47E1-8F77-ED4CB806436D;a5138965-a698-413c-9981-d25313caa02e;e9445fc1-8a27-4a93-8fe7-90ae5f2aaab7; |
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin). Anaerobes Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra abdominal infections such as peritonitis and intra abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. In Vitro Susceptibility Testing A standardized disk testing procedure Bauer AW, Kirby WMM, Sherris JC, et al Antibiotic susceptibility testing by a standardized single disc method. Am J Clin Pathol 45 493 496, 1966. Standardized disc susceptibility test. Federal Register 37 20527 29, 1972. is recommended for determining susceptibility of aerobic bacteria to clindamycin. A description is contained in the CLEOCIN Susceptibility Disk insert. Using this method, the laboratory can designate isolates as resistant, intermediate, or susceptible. Tube or agar dilution methods may be used for both anaerobic and aerobic bacteria. When the directions in the CLEOCIN Susceptibility Powder insert are followed, an MIC of 1.6 mcg mL may be considered susceptible; MICs of 1.6 to 4.8 mcg mL may be considered intermediate and MICs greater than 4.8 mcg mL may be considered resistant. CLEOCIN Susceptibility Disks 2 mcg. See package insert for use. CLEOCIN Susceptibility Powder 20 mg. See package insert for use. For anaerobic bacteria the minimal inhibitory concentration (MIC) of clindamycin can be determined by agar dilution and broth dilution (including microdilution) techniques. If MICs are not determined routinely, the disk broth method is recommended for routine use. THE KIRBY BAUER DISK DIFFUSION METHOD AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES. To reduce the development of drug resistant bacteria and maintain the effectiveness of Clindamycin HCl and other antibacterial drugs, Clindamycin HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0030790;C0037278;C0404521;C0041343;C0014009;C0014179;C0243001;C1112209;C0024110;C0030455;C0031154;C0032285;C0035243;C0036690;C0149778; |
RXCUIs for this Label: IN=2582 SCDF=371555; SCD=197518;284215; |
Similar Labels: 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62; |
Adults (Clarithromycin Extended Release Tablets) Clarithromycin extended release tablets are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below Acute maxillary sinusitis due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae . Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis or Streptococcus pneumoniae . Community Acquired Pneumonia due to Haemophilus influenzae , Moraxella catarrhalis , Streptococcus pneumoniae , Chlamydia pneumoniae (TWAR) or Mycoplasma pneumoniae . THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED RELEASE TABLETS IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED. To reduce the development of drug resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0155804;C0694549;C0008677; |
RXCUIs for this Label: IN=21212 SCDF=371541; SCD=359385; |
Similar Labels: 1f56e340-dcba-4774-b9d9-8e02dd7c3f69;790d3557-0b33-4b92-974a-14dc3e95d62b;a58fc044-95b2-4443-93b0-2ca7a6f6c159;d9db2fd3-a668-4d37-9082-18f6ceb8c3cb;f21494ed-c5e8-4ddf-b140-ecd68c5c312b; |
NEXICLON XR is indicated in the treatment of hypertension. NEXICLON XR may be employed alone or concomitantly with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=2599 SCDF=885794; SCD=885880;885882; |
Similar Labels: 6b2cc55a-250e-4316-9225-3bb93b90025e;9fbc1f6d-37cc-437e-9d1a-c2fa5785b39a; |
Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. |
Annotated Indication CUIs: C0020598;C0035086; |
RXCUIs for this Label: IN=1894 SCDF=379113; SCD=308869; |
Similar Labels: 045f46c7-c637-443b-8427-c461b3d7ca55;406151ad-6c0a-4d66-86fc-e076df9671a3;459595e0-3bb1-426e-bebb-19146262c375;4d6046c2-4a28-47b1-9bb4-51fadeded2d2;63d26a82-4b79-44ce-52a4-395e4368acd4;add1e536-b6ed-4ba1-abd6-084b6845e3a4; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: UPPER RESPIRATORY TRACT Pharyngitis tonsillitis caused by Streptococcus pyogenes . NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae , Haemophilus influenzae (including lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including lactamase producing strains). (See CLINICAL STUDIES .) NOTE: In the treatment of Otitis Media due to lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae , Haemophilus influenzae (including lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including lactamase producing strains). LOWER RESPIRATORY TRACT Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae , Haemophilus influenzae (including lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including lactamase producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including penicillinase producing strains) and Streptococcus pyogenes . Abscesses usually require surgical drainage. |
Annotated Indication CUIs: C0038395;C0149514;C0149512;C0442886;C0008677;C0029882;C0031350;C0037278;C0040425; |
RXCUIs for this Label: IN=19552 SCDF=371336; SCD=197452;197453; |
Similar Labels: 0613b659-2b72-451d-b4a5-30a442364dff;0f96e4fe-8daf-492b-8fd8-90ff25243077;14527f4a-ce99-449d-a5a5-9edd7fb28dee;17a1975e-ce3b-4057-ae5b-8d191319caa7;3391de8b-7bc9-4624-a5c4-836135b39d99;3ec55c0a-1456-412e-972f-352b3135c8f2;6737ed97-9559-44c7-889b-6bc0e20eb36b;6da33de9-7100-419f-a19f-565701b445ad;75d57e35-ffeb-4d88-8dba-5458e284fd82;92da8862-a021-45e3-acdd-6cf6e0c8dc94;97675251-70b8-43bc-93ea-f9ef6bb8cb68;a547cc0a-6af0-49c7-a5ea-c41684cc36ae;b0d460ed-73d0-44e6-9ba3-b2f5345df08e;b9111a81-07c4-4458-b994-a4ad504986d8;c6b4fe73-ce77-4adf-b787-2bdb2dd74f84;c6d3c1ff-d873-4903-befa-c0ba47034c6e;d5574dfc-203f-4540-bce2-c5f83aefc6bd; |
Anafranil is indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM III R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Anafranil for the treatment of OCD was demonstrated in multicenter, placebo controlled, parallel group studies, including two 10 week studies in adults and one 8 week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate to severe OCD (DSM III), with mean baseline ratings on the Yale Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI treated patients experienced a 3.5 unit decrement on the NIMH OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg day for most adults and 3 mg kg day (up to 200 mg) for all children and adolescents. The effectiveness of Anafranil for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo controlled trials. The physician who elects to use Anafranil for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION ). |
Annotated Indication CUIs: C0028768; |
RXCUIs for this Label: IN=2597 SCDF=371572; SCD=857297;857301;857305; |
Similar Labels: 057dded1-9441-40bf-97e6-1049e5c8b8ac;32f05aed-18b6-4269-b10c-5d10f5bf7ca2;33c772f8-08f0-4f99-8fbd-4de48ad82d89;3823106e-6be3-4154-a607-caa3a69dc75c;3c67bab7-783a-4943-944e-938395b1c3cb;4074b555-7635-41a9-809d-fae3b3610059;4c32971e-feb3-4388-9cd6-d1f99f258b0d;5af7ec26-5666-41a9-a0a9-1c3b09f6638e;75347df1-105c-45a2-9c4d-36f3340feac6;7ffd89f1-43ae-4092-8575-d404311da716;db752dbd-be41-4cdd-8a13-ed1ff9ef7461; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. NOTE CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIO EQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM PER MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY ). Cefuroxime Axetil Tablets Cefuroxime axetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below 1. Pharyngitis Tonsillitis caused by Streptococcus pyogenes. NOTE The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefuroxime axetil tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin resistant strains of Streptococcus pyogenes. 2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae , Haemophilus influenzae (including beta lactamase producing strains), Moraxella catarrhalis (including beta lactamase producing strains), or Streptococcus pyogenes. 3. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta lactamase producing strains only). (See CLINICAL STUDIES section.) NOTE In view of the insufficient numbers of isolates of beta lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with cefuroxime axetil tablets for patients with acute bacterial Maxillary Sinusitis, it was not possible to adequately evaluate the effectiveness of cefuroxime axetil tablets for sinus infections known, suspected, or considered potentially to be caused by beta lactamase producing Haemophilus influenzae or Moraxella catarrhalis . 4. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae , Haemophilus influenzae (beta lactamase negative strains), or Haemophilus parainfluenzae (beta lactamase negative strains). (See DOSAGE AND ADMINISTRATION section and CLINICAL STUDIES section.) 5. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including beta lactamase producing strains) or Streptococcus pyogenes. 6. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae . 7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase producing and non penicillinase producing strains of Neisseria gonorrhoeae and uncomplicated Gonorrhea, rectal, in females, caused by non penicillinase producing strains of Neisseria gonorrhoeae . Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi. |
Annotated Indication CUIs: C0271429;C0155804;C0031350;C0040425;C0149514;C0442886;C0008677;C0018081;C0024198;C0037278;C0042029;C0017677; |
RXCUIs for this Label: IN=2194 SCDF=371342; SCD=309097;309098; |
Similar Labels: 07170ee3-1a24-424f-a2a2-00bc92e98f85;0a145288-733a-4966-b7ae-dc96eb103d8c;16a686e6-63f4-478f-a673-02dde9474eda;1c747919-7968-40aa-80b2-e2f7d499a801;1f35ed70-4947-4d4d-b4c8-71ce520fc445;1fd2babd-4737-45ad-9464-a7479a3816d9;2f439b86-59d6-4350-aeb4-c904b3781db4;3bbb25db-ec98-4469-6e9c-8685ab20b0cc;42105671-ad7c-462c-b42f-1cdad94753d2;56ecdeb7-89ba-420f-bbaf-65e4dab305d3;5b6288fa-49da-4f44-b779-86e8404921db;61d3f51b-a8ed-4be5-849c-4bf653538d3e;65daa2aa-cc4a-4eba-b7dc-7a151806865a;68e22782-f3a6-4e2c-8612-3f1608547919;703cc338-c0b6-4a02-b8db-c27aeff181df;708b7a4d-ba1f-47b5-be4d-a01c2a7017ff;7e7517b6-8f9f-4600-881a-9ed8bc1f454a;8cc2bf2e-d51f-4abd-bc08-660c5e5f00de;8da31eca-51cf-4a01-9159-740f772b0f15;98ea197c-b3ff-47bc-8d0f-fce91b539959;9D7666AB-D48A-4507-A120-D7E1229543FD;9ccf0781-4fb3-496e-bd58-54381ea33510;a1c53a0c-78b0-4c6e-b2bc-0ee90cbe9e73;a7b50175-e978-4edd-9d61-593df4806657;ae5682dc-61f0-48ff-9d0d-7ce1aa1c39de;cc834761-8700-4970-ba49-b8ddecb51a1b;ee8787d8-3b83-4a8c-9447-09571aa40964;f4797359-d4a0-4967-86d3-d348518b3fe4;f799137f-9676-42d4-9130-a9685cc9302c; |
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Important Limitations of Use UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population. |
Annotated Indication CUIs: C0005001; |
RXCUIs for this Label: IN=17300 SCDF=370798; SCD=861132; |
Similar Labels: df3c1900-a076-4a3a-a2a8-5939d818451f; |
Monotherapy AVODART (dutasteride) Soft Gelatin Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to
Combination With Alpha Adrenergic Antagonist AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Limitations of Use AVODART is not approved for the prevention of prostate cancer. |
Annotated Indication CUIs: C0005001;C0341742; |
RXCUIs for this Label: IN=228790 SCDF=378716; SCD=351172; |
Similar Labels: 647540fc-bef5-4aa3-be4c-6b30655f366c;813507ec-1fc1-420f-ac5c-5c794b1059cd;dc330e70-a1d3-400b-3aaf-46067e3fd090;ebda6db1-f6ea-4962-a99d-85ad5c96a5aa; |
Treatment Resistant Schizophrenia CLOZARIL (clozapine) is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for Schizophrenia. Because of the significant risk of agranulocytosis and seizure associated with its use, CLOZARIL should be used only in patients who have failed to respond adequately to treatment with appropriate courses of standard drug treatments for Schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. (See WARNINGS.) The effectiveness of CLOZARIL in a treatment resistant schizophrenic population was demonstrated in a 6 week study comparing CLOZARIL and chlorpromazine. Patients meeting DSM III criteria for Schizophrenia and having a mean BPRS total score of 61 were demonstrated to be treatment resistant by history and by open, prospective treatment with haloperidol before entering into the double blind phase of the study. The superiority of CLOZARIL to chlorpromazine was documented in statistical analyses employing both categorical and continuous measures of treatment effect. Because of the significant risk of agranulocytosis and seizure, events which both present a continuing risk over time, the extended treatment of patients failing to show an acceptable level of clinical response should ordinarily be avoided. In addition, the need for continuing treatment in patients exhibiting beneficial clinical responses should be periodically reevaluated. Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorders CLOZARIL is indicated for reducing the risk of recurrent suicidal behavior in patients with Schizophrenia or schizoaffective disorder who are judged to be at chronic risk for reexperiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that puts him herself at risk for death. The effectiveness of CLOZARIL in reducing the risk of recurrent suicidal behavior was demonstrated over a 2 year treatment period in the InterSePT Trial (see Clinical Trial Data under CLINICAL PHARMACOLOGY). Therefore, CLOZARIL treatment to reduce the risk of suicidal behavior should be continued for at least 2 years (see DOSAGE AND ADMINISTRATION). The prescriber should be aware that a majority of patients in both treatment groups in InterSePT received other treatments as well to reduce suicide risk, such as antidepressants and other medications, hospitalization, and or psychotherapy. The contributions of these additional measures are unknown. |
Annotated Indication CUIs: C0036337;C0036341; |
RXCUIs for this Label: IN=2626 SCDF=371602; SCD=197535; |
Similar Labels: 53bdb79c-c4cf-4818-b1f0-225e67a14536;5f0c6f5f-b906-4c8f-8580-3939a476a1c1;77660c47-a2ad-4f1d-80d6-bdc315f04cbf;8672ee49-ee2e-4239-98ce-7e23e1ab7b10;883b5d43-0339-7dc1-f775-93791fb9b978;b7b7541a-1fe4-4b11-b6b7-68fb5510faa4;c43da258-73bb-4ca5-bfe8-1c8a0500f91d;d5c8a456-6f3c-4963-b321-4ed746f690e4; |
Codeine sulfate is an opioid analgesic indicated for the relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate. |
Annotated Indication CUIs: C0278138;C0278140; |
RXCUIs for this Label: IN=2670 SCDF=371613; SCD=997296; |
Similar Labels: 5819bdf7-300e-45b8-8f3a-447b53656293;82ce83dd-6b7c-4efa-9ad4-d31ddc1b4517;f317cd06-2851-4a52-86d3-6efde3a4c243;fa3ed180-298a-4f9d-9d05-15182d7218bf; |
TRANXENE is indicated for the management of anxiety disorders or for the short term relief of the symptoms of Anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. TRANXENE tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of TRANXENE tablets in long term management of Anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. TRANXENE tablets are indicated for the symptomatic relief of acute alcohol withdrawal. |
Annotated Indication CUIs: C0003469;C0236663;C0014544;C0751495; |
RXCUIs for this Label: IN=2353 SCDF=371589; SCD=197464;197465;197466; |
Similar Labels: 499a6989-8912-44b7-b1eb-ee8f85ae378f;54722d55-d620-488f-87eb-e1e3b129c2f9;6d686bb2-3901-4f78-aac7-bf2b83824765;6e9edbfc-1950-4893-9d38-e82b119ddb9a;7abac94c-ba0e-415b-9196-72caf153cc7c;92a354fb-efb3-4ebf-acfa-1c258d8664a6;a6cc08b8-146e-430f-af39-8b866698b997;d2b23109-e033-4535-912e-92d07f498edc;d57138fd-067d-43f8-80d5-9190cf90ef3d;f22310ac-5481-4270-ab46-88ad4f654b45; |
ZEBETA is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=19484 SCDF=371104; SCD=854901;854905; |
Similar Labels: 2564646d-183c-4759-8726-155a4c22aa2b;4f20df45-3f9c-4a91-b394-e93a08111ec3;621d9058-804a-4f46-a047-ea6e432eee49;70f7b118-8a74-40d9-8a7c-c39744a6ebd7;7f888a0c-189e-4c76-86d8-7bc6f21e3b16;a11548a0-9c0f-4729-907c-75d8f99a6c85;a1dc3675-ca21-4fdc-bc4d-e82381e31851;b9bbf9ed-4781-42a9-bc3e-deda9f05e810;d82243b9-3e56-4a2b-8750-cb95ec106885;dba0b86a-5581-45a8-a956-716c2a718eb0; |
Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's Disease who have had an inadequate response to conventional therapy. REMICADE is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's Disease. Pediatric Crohn's Disease REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's Disease who have had an inadequate response to conventional therapy. Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active Ulcerative Colitis who have had an inadequate response to conventional therapy. Pediatric Ulcerative Colitis REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Ulcerative Colitis who have had an inadequate response to conventional therapy. Rheumatoid Arthritis REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active Rheumatoid Arthritis. Ankylosing Spondylitis REMICADE is indicated for reducing signs and symptoms in patients with active Ankylosing Spondylitis. Psoriatic Arthritis REMICADE is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with Psoriatic Arthritis. Plaque Psoriasis REMICADE is indicated for the treatment of adult patients with chronic severe (i.e., extensive and or disabling) Plaque Psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow up visits with a physician [see Boxed Warnings , Warnings and Precautions (5) ] . |
Annotated Indication CUIs: C0003864;C0341318;C0034895;C0038013;C0010346;C0406317;C0003872;C0003873;C0009324; |
RXCUIs for this Label: IN=191831 SCDF=376873; SCD=310994; |
Similar Labels: a0a046c1-056d-45a9-bfd9-13b47c24f257; |
EVOCLIN Foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. |
Annotated Indication CUIs: C0001144; |
RXCUIs for this Label: IN=2582 SCDF=477452; SCD=477451; |
Similar Labels: 2e6f96d0-d928-4775-a7db-3e998fce675b;fcb96831-1c51-4003-adc2-3a3c34e45feb; |
Thalitone (chlorthalidone USP) is indicated in the management of hypertension either alone or in combination with other antihypertensive drugs. Chlorthalidone is indicated as adjunctive therapy in Edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in Edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when Edema is due to pathologic causes just as it is in the absence of pregnancy (however, see WARNINGS below). Dependent Edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease) but that is associated with Edema, including generalized edema, in the majority of pregnant women. If this Edema produces discomfort, increased recumbency will often provide relief. In rare instances, this Edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. |
Annotated Indication CUIs: C0013604;C0018802;C0023890;C0020538; |
RXCUIs for this Label: IN=2409 SCDF=371472; SCD=197498; |
Similar Labels: 15dd224a-87ad-48dc-80b1-e8382a452c4c;193c85ba-43c2-4be2-82cf-7b394a83390e;527180e9-7172-4811-87bb-bb47439b5542;950bb805-3ca7-4f54-b4fb-c9e23cb33ae2;bb7112ae-3a37-4525-8c7f-c0f4100ffc0a;c10e3a16-d94f-442f-9303-4ded0adaecc1;e2eb7dad-3ea3-439c-dcbb-d1d61aa49dfc; |
Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Lotensin, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=18867 SCDF=371001; SCD=898690; |
Similar Labels: 09e383a8-e912-4cf7-8fb3-05545af80dd0;1b86bd94-7734-4080-8fab-11d226f71a37;2c438366-8cad-7be6-1006-15d5a25c7a9b;420a70f6-7b8b-42d0-8511-5320c841ef85;56027610-8270-52f9-5e0d-782630d98e45;56ffd662-60a6-4b43-a7ea-f778714dfbbd;5b647f4a-a6fe-49db-bd8f-9ca75dce7653;60f0fb82-d870-4f07-82af-e4aeb79ed023;74898baf-c41a-4b24-9522-ece64ab7a516;756a3a26-7230-410b-bfb1-7f074688ff05;8fdc8bda-635a-401f-a9b5-8a2a514b429e;99b9019c-f650-5465-5edf-80f656d06611;9f2fce5a-fee9-4df3-8aef-b1d2cc9a14c4;a2431e04-d610-4d3f-ac93-3d96e28b984f;a852de3b-0efb-46cf-9472-2cab96f67972;cb3c47b7-4f27-40a0-ac8b-c4df0b100909;d73713c3-3c48-4cce-8437-1723ca54d077;decda177-7c1a-4d28-84fc-c6d7aa251561;f2da9586-8baa-4852-8669-80dade6363cf;f85164b6-a03e-4944-bae5-cd1389929f83; |
Carisoprodol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. |
Annotated Indication CUIs: C0184567; |
RXCUIs for this Label: IN=2101 SCDF=371288; SCD=197446; |
Similar Labels: 1fa79b11-6491-4543-8548-8aaa624f7ff8;7d7d44b4-d405-4c48-9e79-cc128dd7aaeb; |
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra abdominal infections such as peritonitis and intra abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. |
Annotated Indication CUIs: C0030790;C0037278;C0041343;C0404521;C0014009;C0014179;C0243001;C1112209;C0024110;C0030455;C0031154;C0032285;C0035243;C0036690;C0149778; |
RXCUIs for this Label: IN=2582 SCDF=371555; SCD=197518;284215; |
Similar Labels: 00088ecd-e45d-4080-b124-e66376ad7694;05a75685-0af5-407c-ac57-e380c882b49d;14319e53-5148-4857-2093-7a83b0efc3be;166d6d61-e9ce-4c8a-91ec-72d7a9d0af8d;192643cb-325b-4951-925f-ee2bc3e21983;1dbd8448-c1e5-46df-8060-50ef82380445;1ef87b6c-9d32-44ac-8c55-8bf01424cc45;2367340c-d297-4a3f-8253-6d27a0ed39cb;300e15d2-7782-45d9-bb9d-b1acc520cc64;363d5e7d-2734-4a26-8b7c-a75a707dbaae;375c42d4-e222-45a5-a0f3-34c871abca42;3f6b2c5a-e581-414f-bc9e-eaf66a5685cd;458e043d-6584-4503-b398-2032d3cce2f1;49a643c3-14ef-4bfd-bb66-be05e1696c7e;4b33e408-01cb-4cd0-b9aa-aa5409228d91;4ced0e9d-fd23-419f-9053-3d4c0340d5dd;54e4cd15-3d98-4e04-b07c-9dcefb37578e;63a0466c-af7d-4696-a950-19b73b55a65a;73502d97-7131-4767-95fc-e5eaaa940ba7;7a6967b3-5563-4bed-9eee-d400f800e799;7d72c291-d96f-468d-b3bb-8c255c4906b1;84329aad-63fc-54b1-dc05-c08461f00221;91d2ee16-af0b-429f-b859-ed5cc95599df;9250d33e-3429-4ad5-398b-b9b7943d9ff9;9891d1bd-b662-4242-a01e-8151463bbf2d;98f47953-c344-421c-a171-3a822be34728;9ac0f81d-27f2-4db5-ad07-346f40133084;ab528098-e7c1-4f92-acb2-b664320a95a1;ab7233b1-b68e-458b-9e1d-4fc3fa15e8b6;b0442dc3-7f06-4f67-ab14-f338ae5173e7;b225ab20-bc7c-43af-ae93-0f07d5948e1c;b8133f76-8880-4b91-a451-b3f831ad6853;b91d122d-a68d-4158-8f63-68c886d05bdf;bd1c1648-4733-4233-8337-469fe11bd0cb;bd79aebb-b221-4844-8e4a-f848b7c52f16;bdb9e366-7234-422d-a3ab-0765824bb7a7;bf606d63-712e-4345-9231-ea35db44743b;c8616135-1ba4-4256-ada7-1d6ae20a4416;cd483920-c315-4397-84b8-57d393e753fd;df4d7c10-d50b-4aee-88c1-cd4e4dc890a8;df9a2a41-b132-4f43-8940-b2d773b1369a;e17229b3-7246-4886-abe6-58e39c4e47ef;e4505f39-ebb0-4a0b-b91e-17fc42466c21;eabd3c7f-028d-4299-4b9b-60c75af7ee01;f9e6ed50-ad03-4a9e-8760-8733e04a058c;fc294a54-61f1-4d3c-8b42-8376935b21f7;fc2f2fe8-040a-4280-80fa-7f47ce63bb09; |
Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Important Limitations of Use Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population. |
Annotated Indication CUIs: C0005001; |
RXCUIs for this Label: IN=17300 SCDF=370798; SCD=861132; |
Similar Labels: 0feb7a22-7416-4502-bf6e-6341782d11ab;23ba1d84-686f-41f6-ac83-8d839ae25350;26fcc267-c8d7-e059-1bcf-830dded43690;2d4f6e4f-e385-b872-38c6-b7d1a9e8f9b9;30f97b8e-4486-4b5f-896a-d7dfa1e2e33a;6220496a-b651-4e7b-9a41-0ea949de3df0;8704702e-0889-4a47-9a92-588a8d72d503;be485a4c-aba3-43fa-9904-403595bc3f96;d2af616e-673a-4fdd-ace8-db2d0f154604;f861c40a-504b-42c0-a17d-af35c0f187f9; |
Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=18867 SCDF=371001; SCD=898687;898690;898719;898723; |
Similar Labels: 11b3ea2b-02dd-40dc-b073-f8f25bf1a2d2;4d954024-a191-46e3-ba71-2a7d5b0c65d5;a216253b-27cb-42ef-b5a8-67fb05aafb88;c51a3704-c5b3-471f-afcb-0602da0f3dce;cc51387c-c645-4d27-954e-5efba5d0db98; |
Levalbuterol HCl Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. |
Annotated Indication CUIs: C0006266;C0600260; |
RXCUIs for this Label: IN=237159 SCDF=378650; SCD=242754;311286;349590; |
Similar Labels: 1700a5b8-4029-424a-bfed-15f6737dd210;206bbdec-04f0-40e3-a259-32fc6bce20d8;218ab3f0-4d1e-4c33-a7e8-27807f029d83;320fea02-8aa3-44c8-b52a-a118418d1f78;35eb525b-72a5-4ef9-a36a-531e9e6b3560;4c4cf6b3-36d4-4b41-84e9-682012d7e4e2;91b2b443-bdc7-4045-bb94-906199125f49;a1e9d249-33d1-4b14-b92e-8f4dccded1da;d91161c1-cae8-4d69-a37c-fb7b64b7736a; |
MULTAQ is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) ]. |
Annotated Indication CUIs: C0004238;C2585653; |
RXCUIs for this Label: IN=233698 SCDF=854855; SCD=854856; |
Similar Labels: 236d4549-f44b-4677-b857-acedd10b9920;7fa41601-7fb5-4155-8e50-2ae903f0d2d6; |
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. |
Annotated Indication CUIs: C0018802;C0013604;C0023890;C0020538; |
RXCUIs for this Label: IN=2409 SCDF=371472; SCD=197499; |
Similar Labels: 49ef8384-946d-43cb-b9be-f174e789d7dc; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Adults and Adolescents: Community Acquired Pneumonia: Caused by Haemophilus influenzae (including lactamase producing strains), Haemophilus parainfluenzae (including lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), and Moraxella catarrhalis (including lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis: Caused by Haemophilus influenzae (including lactamase producing strains), Haemophilus parainfluenzae (including lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), and Moraxella catarrhalis (including lactamase producing strains). Acute Maxillary Sinusitis: Caused by Haemophilus influenzae (including lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), and Moraxella catarrhalis (including lactamase producing strains). NOTE For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE Cefdinir is effective in the eradication of pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following pyogenes Pharyngitis tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections: Caused by Staphylococcus aureus (including lactamase producing strains) and Streptococcus pyogenes . |
Annotated Indication CUIs: C0155804;C0008677;C0694549;C0031350;C0037278;C0040425; |
RXCUIs for this Label: IN=25037 SCDF=371325; SCD=200346; |
Similar Labels: 06d55c37-5b80-45b6-bfea-6b00fd960ed4;06fbdb63-d32f-4212-9962-f1de15597dda;38f6adf7-e26c-4764-8ec9-360813874dd4;5fb3c464-ab1a-4e2f-ba7a-9aa59b94ca00;7490df67-56c0-4a1c-8533-2107f3e8aea5;7cab718d-2a6f-4792-b94c-be87ebed5cf3;929126e0-302f-47a5-b1a9-3474ff9befc7;BB96F3CF-FD80-40C9-A6AA-C7464AB3226F;a1f49fe1-b511-4f6b-a912-8ae8662d95a5;a3262279-1f9e-401b-9b02-6da3ef374b46;a4587ea9-c06b-4603-beea-1ef926a4d0be;a78a68a4-5425-43c4-81cc-7733b72445b8;a84712bf-221d-4366-9cf0-b8c19428c276;a9c339ac-14a5-465e-a4fe-1d361d017ccf;bcf04f49-8d0b-4563-9d0f-93939cdf6a6c;c3ca8720-8e27-47ed-9829-a42ae9eb885d;cb7366ce-1778-451f-aba5-65cf73c9b87a;d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4;de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c;df26edb0-9bd6-449c-a187-0be0c9e2600c;e1aba7cf-52f5-461d-a8f5-9bb580da99d0;f910ec1a-3896-45b9-b8b2-df50a50064a1; |
KAPVAY (clonidine hydrochloride) extended release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The efficacy of KAPVAY in the treatment of ADHD is based on two controlled trials (one monotherapy and one adjunctive to stimulant medication) in children and adolescents ages 6 17 who met DSM IV criteria for ADHD hyperactive or combined hyperactive inattentive subtypes [see Clinical Studies (14) ]. In the adjunctive study, KAPVAY was administered to patients who had been on a stable regimen of either methylphenidate or amphetamine (or their derivatives) and who had not achieved an optimal response. The effectiveness of KAPVAY for longer term use (more than 5 weeks) has not been systematically evaluated in controlled trials. A diagnosis of ADHD implies the presence of hyperactive impulsive and or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive impulsive criteria to be met. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM IV characteristics. KAPVAY is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. KAPVAY is not intended for use in patients who exhibit symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational vocational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe KAPVAY will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms and on the level of functional impairment. NOTE This extended release formulation of clonidine hydrochloride is also approved for the treatment of hypertension in adults under the trade name JENLOGA. |
Annotated Indication CUIs: C1263846;C0020538; |
RXCUIs for this Label: IN=2599 SCDF=885794; SCD=1013930;1013937; |
Similar Labels: c9bdfcda-82a0-4084-b9b2-1e367c0418d6; |
For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. |
Annotated Indication CUIs: C0042963;C0162565;C0260653;C0149654;C0019521;C0424295;C0005586;C0338831;C0027497;C0085631;C0036341;C0039614; |
RXCUIs for this Label: IN=2403 SCDF=371461; SCD=991213; |
Similar Labels: 112393f8-b374-4ee0-8fcc-f229fadbe637;298de270-99a5-47cc-9116-a91fd6099385;33c01749-ef88-4e9c-8b45-0f026af1d5fd;533f3ed8-4569-48e2-95ee-efe428896b8d;8e86b2c6-b449-4abc-97fb-e78702bb1b83;9ba1cfd8-14c9-4de6-88cb-8a78a1d40a53;b028fb3d-2939-4197-b31c-ac327f9593ec;b9d57be1-17cb-42ac-8334-ef3494be7f17;c0f1fcfd-8863-4032-bf80-185df60a4ba0;c267e103-028c-4a57-9f6e-89a652599342;c63d6612-3fd2-44dd-a5c7-a093766b91f2;f15e9f35-1e3e-4217-b8e2-1d6096dbee1b; |
Treatment of Bacterial Vaginosis Clindesse is indicated for the treatment of Bacterial Vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non pregnant women. |
Annotated Indication CUIs: C0085166;C0042267; |
RXCUIs for this Label: IN=2582 SCDF=890920; SCD=890921; |
Similar Labels: dac31f82-b35e-49b9-aff9-f0101292f1be; |
Clarithromycin for oral suspension is indicated for the treatment of mild t moderate infections caused by susceptible strains of the designated microor ganisms in the conditions as listed below Adults Pharyngitis Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present.) Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae Community Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR). Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.) Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non clarithromycin containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Children Pharyngitis Tonsillitis due to Streptococcus pyogenes Community Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR) Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae NOTE For information on otitis media, see CLINICAL STUDIES Otitis Media . Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.) Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare Prophylaxis Clarithromycin for oral suspension is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. To reduce the development of drug resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0013295;C0271429;C0155804;C0694549;C0031350;C0040425;C0008677;C0026918;C0037278;C0038395; |
RXCUIs for this Label: IN=21212 SCDF=371539; SCD=309322; |
Similar Labels: 066f4be0-054c-4b34-aa0d-941ddc529610;144e4973-d24a-4003-b5b1-d59fd835d884;22457862-0f88-4be8-b507-1c8f264269f2;2e899f4a-a2e9-445c-a0ed-6ad811e997e6;38642D80-AAA6-4196-A033-3977FF35B48A;3fed77ce-ad29-48e2-a28b-6d1501d0b090;4b9d7052-a54f-3ee1-ab0e-633b087f4802;52c09a36-879b-4b0e-b3a5-f4a4bba9bde5;624a18c4-f07a-4f8a-9a14-bbfd9c6c7c68;73bd377e-cd9a-4d34-aa6e-7a1e44b47b89;81506e45-3d35-4462-ad4c-1584a186023b;882bbf32-8a87-4479-a2a8-92637abfdd75;8aa4f3fc-720b-448b-ae8b-9bb3a9ff6d42;903939b3-a01d-4593-85ca-cfe8d4d48d3e;90d35dd6-a918-c4ab-bc7e-43652ce9b3b4;92ae2611-637c-4a9e-8e95-2d8fa8191f03;94c182ed-f2d6-4f7f-bdd9-69b136c54623;9aaffb41-408c-4372-8fd5-1d649450c0e9;aa44552c-3cfe-4111-8aa5-4251aeed9be9;adedec4c-e9b0-44ef-9ed9-741adcdc84d7;b98b02bb-2609-49a0-b29f-e5911aa0cbc1;c14051fd-deeb-4340-b9a9-9482ef6c198c;f3a50f13-b028-4135-8f20-bfb62a9bc0a9;fa1a9323-3b54-4b6b-850d-ae5b7d5ccbc6;fa89af8a-4c53-4389-a2e1-22d4ca8b4bb9; |
LEVITRA is indicated for the treatment of erectile dysfunction. |
Annotated Indication CUIs: C0242350; |
RXCUIs for this Label: IN=306674 SCDF=378688; SCD=349478; |
Similar Labels: 08b737e8-9d9c-4d04-b91b-1f0c5fe065c7;0e5139d8-bf61-4f21-a36b-81b96b9b07d1;34c30372-08b0-4060-8aba-779b5bc1e5dd;4e66ad5c-572c-4819-8b6e-6930c33cc210;517fbb02-8793-4647-83c7-25a91be49622;80971965-5c77-4950-b65d-7996b802d2cd;8f935afa-f845-46cd-b61a-db7a48e559c0;a01def95-c0ef-43b9-bd9e-5565b2385ad3;b3bbc16e-8305-469a-9dc3-8e698339a98b;be38b325-3a6f-4569-9ae0-a03feff8535d;f18a82f7-ce44-4f9c-ae69-d3ad1d375564; |
Hypertension BYSTOLIC is indicated for the treatment of Hypertension [see Clinical Studies ( 14.1 )] . BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )] . |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=31555 SCDF=393308; SCD=387013; |
Similar Labels: 895cb85a-5ec8-4070-babf-d1325c028677; |
Acute Coronary Syndrome (ACS)
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease For patients with a history of recent myocardial infarction (MI), recent Stroke, or established Peripheral Arterial Disease, Plavix has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. |
Annotated Indication CUIs: C0948089;C0027051;C1704436;C0038454;C0002965;C0022116;C0948008; |
RXCUIs for this Label: IN=32968 SCDF=374583; SCD=309362; |
Similar Labels: 0005e2a8-3ab9-4173-a46f-9c53881379e2;0078fb3d-3595-4ae1-a059-1d5e81c879cf;01b14603-8f29-4fa3-8d7e-9d523f802e0b;03bec9ad-cd22-44d3-9b82-2796157de1d1;079ed521-3ff0-47fa-86d5-a336732056cc;10360cf0-1671-3cbe-cd7c-2c8e8753bd1b;1086a7b4-b89b-4bee-8120-5f752626c046;3d021d9b-c0b8-41a3-a99b-37f50d2a20ae;3e08ca1d-35ef-4b65-9799-5c62c6444d26;488e765a-7f2d-4323-8a5c-114a46862e8f;4da4da53-91ae-4d4f-145f-255c5db443a5;4dbcad6e-90d5-4f38-9b69-72bbcac38fcc;7109fd74-54c8-4abd-90cd-71892edfd243;710bede3-2742-4413-8772-63b2a955fab5;a9a3c560-2408-4dd0-9f83-ee3e3a549c7b;ae07b785-b522-41c6-b27c-24c4d5cd814d;b5aa951f-72de-bea1-98a2-a4085c64a361;bc747f6d-f52c-4dcb-bda5-2d0a9f954147;c3248d43-3dd6-4ca9-afca-528c7abe0fce;c62e99a1-0612-4c76-9c72-80c6b78e3567;cb1ce9ec-4f07-4cc9-85bb-663ee1f2ccc7;d37db064-3a5a-4a0c-a60b-b4b417fe742a;de099108-7445-4632-b85f-93a1bc05adf0;f1d77dba-9dae-4f30-b3e3-b4898993f865;f3cb9331-a57d-428c-a13c-7ba5f2eeab14; |
Diazepam is indicated for the management of anxiety disorders or for the short term relief of the symptoms of Anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0003469;C0085631;C0236663;C0001957;C0233777;C0037763;C0026838;C0040822; |
RXCUIs for this Label: IN=3322 SCDF=371786; SCD=197589;197590;197591; |
Similar Labels: 09c6e0a1-85ad-4450-cb99-7a6b7b0d3aff;187e6805-d568-4fa6-8515-46e6677d9a4e;1995880f-e2f3-4eda-b7ff-b28141d38185;1aaf9375-ae3d-4fed-9cd1-24102e00be1a;1e6c2f52-73ff-429b-8f1b-9b5b61ce1ac5;23d3765c-8f10-4bfc-9489-e1ed064ad813;2befa9af-080e-4bad-8654-5de50029ad12;2c2339ed-d8d7-4fe3-f197-41adb8931fc1;2d96a6cb-326f-4c04-b5d7-24d7f7c20699;38399c4a-f304-41ef-aa7d-05c468a7802e;41044928-dd1f-40bf-1fa6-709dff559124;484acfc4-6f1a-4abe-9eaa-b1b8ea7f90e6;48aa32cb-047a-414a-822e-82a5f26d8817;5051e98b-3817-61aa-dba8-bd8be2f0c086;528b98f2-0055-4c40-a3a1-10f70971366a;66ea2936-8b6c-4b72-b077-ecf88e83fee7;78d5a77d-5ca7-4f16-b4d0-fce86456593c;792c3767-f660-4d13-89ed-c69e925f2232;7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f;9a0ce899-0504-4095-85b1-d7957fe3f72c;b1e06f3a-8e4a-4d88-9893-83eacaeb31ea;b326c66d-5762-4d16-933c-619fa2088ccd;b5488932-2f9f-4110-af27-82e422d63ed4;ba953b22-f0cd-4be5-9e0e-178bded88727;c2768add-5e01-4ff4-afa3-230380d59a1f;c397a9da-862f-4f3f-8109-7d21691de53a;d1b5762f-307c-4c99-977d-d91d7dd22141;e5f4151c-ee35-4ff7-8374-ab202642373c; |
Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity. Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information. |
Annotated Indication CUIs: C0751495;C0234533;C0014544;C0036572; |
RXCUIs for this Label: IN=3322 SCDF=759698; SCD=801957;801961;801965; |
Similar Labels: 7733052d-177b-49da-949e-4d950bd2afeb;A84A73A7-8E3A-4985-8BE0-04B3028F5E49; |
Gout Flares COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute Gout flares.
Familial Mediterranean fever (FMF) COLCRYS (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of Familial Mediterranean fever (FMF). |
Annotated Indication CUIs: C0031069;C0018099; |
RXCUIs for this Label: IN=2683 SCDF=371624; SCD=197541; |
Similar Labels: 56c130d1-7581-4152-99a2-0014ee9366c0;5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7; |
DEXEDRINE is indicated in Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM IV) implies the presence of hyperactive impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; on the go ; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM IV characteristics. Need for Comprehensive Treatment Program DEXEDRINE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician s assessment of the chronicity and severity of the patient s symptoms. |
Annotated Indication CUIs: C1263846;C0027404; |
RXCUIs for this Label: IN=3288 SCDF=371751; SCD=884520;884532;884535; |
Similar Labels: 18b7c145-3e8f-4e7e-c6b5-080d4139a008;3cd6be27-de51-4a5f-93b1-b08680cff5b7;69c40af8-3710-46bf-bd3d-137fe5eea23e;a0860402-057c-40ce-902c-6ec5d6545132;a37b6ef9-78b4-4b18-8797-ecb583502500; |
Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens Johnson syndrome). Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases For the palliative management of leukemias and lymphomas. Nervous system Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic diseases Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. |
Annotated Indication CUIs: C0001403;C0848309;C0005138;C0037274;C1260899;C0014130;C0017178;C0018939;C0022658;C0035204;C0035435;C0038325;C0029077;C0149896;C0035440;C0001622;C0038013;C0004096;C0011615;C0006114;C0001627;C0011616;C0011608;C0011633;C0014742;C0011606;C0002879;C0020437;C0020517;C1260899;C1704321;C0043117;C0553662;C0023418;C0409974;C0024299;C0026769;C0026948;C0030807;C0085655;C0033687;C0003872;C0041327;C0034902;C0010346;C0003873;C0018621;C0271738;C0154301;C0036830;C0024141;C1956391;C0040147;C0040896;C0041318;C0009324;C0042164; |
RXCUIs for this Label: IN=3264 SCDF=371729; SCD=197577;343033; |
Similar Labels: 00f36d47-e971-4f05-be7b-8e354339ca62;0277cc0a-2fd4-4605-a310-b613be84ee26;0372f916-0a26-4115-8075-2d575bfbc15e;0ee281c8-7624-46b1-a8fe-e2a295e6c46a;1399ff8e-378e-4624-96e4-867402bdbe05;1495284D-750F-437E-8525-6834CCCB78EB;1ae5e09b-90e5-4c8f-bf41-87d71ccfd267;20d1ffa7-0a0a-4a16-a2ec-347c21693e80;2ceb3a01-f5bb-4538-b5c1-cea400901d02;2e792ffd-1a5a-415b-8cd9-7f84ac4c5e51;320747b3-5cf1-4e0c-b670-c6a9e72a8845;428cc7bb-e0f9-466c-b38f-11ac22cda752;4a728c5e-0de6-4f05-b293-5d7799b7edf1;537B424A-3E07-4C81-978C-1AD99014032A;5564ee46-7bd7-4b2a-ad51-d01f7fda0461;5cd6b7e5-e52b-4ac3-96d8-8d3f5245cf43;7021a1c8-d2b4-455d-b6fd-4d2658b7b55b;736861fa-1df8-4afd-ba4a-dd7d7bffd865;7658e4b2-5b0d-487a-a603-8fd264cb02ea;7a7ee007-cd02-4f3f-8f0f-82c4964da6e6;7cf5c17c-a80b-4547-83b2-0d53e2b933f7;7d16a8fc-81d6-495b-9fdb-a540d6b883b9;827ce261-307b-4398-8993-333c08e601fe;89e1d458-7caa-430f-9c54-360889899a73;8ed678e2-8a6a-418d-af99-af46d54ae5c4;ae770b46-173e-42f8-b83e-efeb11b0fb11;b15200fb-1826-472b-a907-e677a272513b;b605c62b-5d6b-462e-93aa-2a956d2239fe;bf8acfdb-8dc8-4a69-90b0-33c680c421d6;c68c10f0-6970-4157-904c-b56ef80c5842;c6eb10d2-2251-482b-8a57-fea31c05bc7e;cca2c160-9188-48e8-9505-49a52388dcb7;ce01733f-33b7-483e-9bc4-cf43937e6998;da9af3d2-c0fb-4e92-bb57-5e868d8c6696;e021aa60-bfeb-4125-a946-0ea013aeeed2;e59d3b87-af2e-4262-b89d-e95aa79f11b7;e5c28db5-efce-49a7-9e5f-12338d1f216b;ec27c135-8ffd-4487-a4fa-7c0514e843e6;ec65c1ea-31af-4858-8c17-885b3f24a49c;ff045cba-f55a-4368-8045-d783694adb85; |
Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient s weight, in kilograms (kg), divided by the patient s height, in meters (m), squared. Metric conversions are as follows pounds divided by 2.2 = kg; inches x 0.0254 = meters. The usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride is indicated for use as monotherapy only. |
Annotated Indication CUIs: C1281429; |
RXCUIs for this Label: IN=3389 SCDF=371822;371823; SCD=978654;978668; |
Similar Labels: 04bd05c4-0d36-4580-94ec-2119d8d58644;0971fa2e-d660-48b0-9fbb-96a2db167b92;330965ca-154f-42d2-bb7c-9494bf036c92;355a06ff-557d-4252-884d-8f3ee165b658;3a283f1b-486f-4100-8f97-aa0350cc9b8d;4fdbc049-6497-4ea0-8788-d2b2963328f7;701ba14c-e668-4308-8430-765a7aad47fa;a750a1ef-8f3e-4870-97eb-3697aaca1818;af3d7879-7160-5b02-01e4-bd02f53c8018;b26c2f51-7436-4622-a174-3f3978a1fda2;ba26f274-f385-49be-aef1-7041d146b9f7;d6ef01d5-791a-ac09-39c0-de1f6e035c65;dab53f4f-68d4-4477-a2b6-ad44a956332b; |
ZOVIRAX (acyclovir) Ointment 5% is indicated in the management of initial genital herpes and in limited non life threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients. |
Annotated Indication CUIs: C0019348;C0019342; |
RXCUIs for this Label: IN=281 SCDF=374473; SCD=197312; |
Similar Labels: 07cd75b9-ffc1-43aa-ab30-4e5ded98102d;456071c1-74b9-42c2-a893-00f0bfbd0430;50278e0e-da1e-45ee-9fcb-672b2a219911; |
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with Narcolepsy, obstructive sleep apnea, and shift work disorder. In OSA, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of modafinil in long term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long term usefulness for the individual patient. |
Annotated Indication CUIs: C0027404;C0520679;C0917799; |
RXCUIs for this Label: IN=30125 SCDF=372944; SCD=205324; |
Similar Labels: 0c634b7a-cce6-4c3d-9c49-63593755f49c;108a276f-b07b-d94f-4488-c3e3b6683d4f;5053c113-69df-4ade-a186-02bc054c23d1;8b79d52e-e6e5-4aaf-8835-242c72d6ee38;91d2f78d-8501-45d8-b6ff-33b393f75079;9f3b0bd2-72a3-411f-aeec-b533373f1a97;a85d5629-748d-4920-b0d6-3012a0ace1a3;def2a743-ec37-452e-8e6b-b15f72ad2215;e16c26ad-7bc2-d155-3a5d-da83ad6492c8;eba3a655-074b-46b3-88cf-3e6b2c0c8b15;f3b3097f-80b8-4410-af21-dcdea144e3c3;fd75a8a7-a8ab-4141-9af9-989a220b9c19; |
VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. |
Annotated Indication CUIs: C0878773;C0150045; |
RXCUIs for this Label: IN=322167 SCDF=477371; SCD=477367;477372; |
Similar Labels: 9acee910-cdb2-4052-b8b3-c26aff1c8716;e433dc68-6b2a-4c48-beae-4ec946f1ff1e; |
Hypertension BYSTOLIC is indicated for the treatment of Hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )] . BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BYSTOLIC. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe Hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their Hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=31555 SCDF=393308; SCD=387013;751612; |
Similar Labels: 673f5ad2-c09b-4a89-9407-efdadd007917;8b8ad213-1dc8-454e-a524-075685c0e1a8; |
Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. |
Annotated Indication CUIs: C0035457;C0009766;C0221207;C0343065;C0035460;C1527304;C0002792;C0002994;C0018621;C0042109; |
RXCUIs for this Label: IN=3013 SCDF=702213; SCD=866021; |
Similar Labels: 21c25efc-9230-4c62-97d1-a465b12d6638;54686520-506f-7765-7220-436f736d6963;76f11fdd-6089-47a1-b1a1-ee1bf490dc97;8aa0e888-3e56-41f1-9305-03dc4fb18571;8d2bd313-3ab3-4fed-81d6-d2d81edcb206;963ded24-0367-44ca-a68d-66c385e76e69;A3C95613-3C12-440C-9C9A-D0A999E05631;b9e618d2-1178-d8e3-5479-8442b41ed8ff;e2bf4d46-6585-41d9-868c-98603b165d5b;ef230444-80fd-4724-9e84-08b32c06a033; |
Benicar is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Benicar. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=321064 SCDF=378991; SCD=349373;349401;349405; |
Similar Labels: 18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d;33770d80-754f-11de-8dba-0002a5d5c51b;ae3e0a4e-3a0c-4589-adb0-8fc3a5510f5b; |
Hypertension Ramipril capsules are indicated for the treatment of Hypertension. It may be used alone or in combination with thiazide diuretics. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=35296 SCDF=373748; SCD=198188;198189;261962;845488; |
Similar Labels: 055bb582-67cd-425a-8823-d543c14305ce;2e6303e8-1c22-451f-8733-a55e237ff961;496b346b-ca79-4483-a950-bed9464e6a9d;6337161a-4ce8-4c58-a812-f19819acea87;7e9e84f7-ff47-463d-bf47-7a9745960aae;a1064f8a-90f5-4c66-9f3c-cd5f17260eb9;a4b65854-1438-42c1-badd-4fa2245277ab;a8cdec12-81d1-4ef4-82c0-d05d93c37a07;abec7409-1d19-631b-1884-8f40337ef865;d6d57158-e8f9-4c91-8317-0374e0c87d33; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules USP and other antibacterial drugs, dicloxacillin sodium capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dicloxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug. (see CLINICAL PHARMACOLOGY Susceptibility Plate Testing ) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase resistant penicillin. |
Annotated Indication CUIs: C0038160; |
RXCUIs for this Label: IN=3356 SCDF=371805; SCD=197596; |
Similar Labels: 2861a407-7898-489d-a43c-1e316341863e;33434f66-1d36-4506-9b3d-9755c978d9b2;3393668f-ea58-442e-b293-c7107b69d1af;5913023a-e3e4-4961-8adb-a299d9e66a37;5e878949-ae82-41e9-9fc6-3c54fe28c032;65c3e99b-ec77-416c-ad70-596d6f0a9c31;8478f242-c715-4984-ac1d-dc79dc28665e;9e2bbe03-44cb-45d1-acdb-b61d9016055e;c17cd62d-ff5d-47ba-8673-3346c7f2365f;e12a13dd-b93d-452c-8671-aec751ddaa4d; |
1.1 hypertension Tekturna is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with Tekturna. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=325646 SCDF=692500; SCD=1011736;1011739; |
Similar Labels: 4c222831-90af-4336-8bf6-5628ddf24326;833c7a0b-5f64-4363-94d5-9a179049113a; |
Treatment of Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis NEXIUM I.V. for Injection is indicated for the short term treatment of GERD with Erosive Esophagitis in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral NEXIUM is not possible or appropriate. |
Annotated Indication CUIs: C0267055;C0017168; |
RXCUIs for this Label: IN=283742 SCDF=486498; SCD=486501; |
Similar Labels: c325bbfc-46f3-471e-7bbc-ed0d6965d13b;dce12085-d6c4-48a5-959b-e771c413c9c5; |
SPORANOX (itraconazole) Oral Solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY Special Populations , WARNINGS , and ADVERSE REACTIONS Post marketing Experience for more information.) |
Annotated Indication CUIs: C0239295;C0553694; |
RXCUIs for this Label: IN=28031 SCDF=378651; SCD=348506; |
Similar Labels: ae50721d-ee15-4ee7-9fe7-afd98c56461b; |
Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis NEXIUM is indicated for the short term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed Erosive Esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered. Maintenance of Healing of Erosive Esophagitis NEXIUM is indicated to maintain symptom resolution and healing of Erosive Esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease NEXIUM is indicated for short term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. Risk Reduction of NSAID Associated Gastric Ulcer NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy (NEXIUM plus amoxicillin and clarithromycin) NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate pylori Eradication of pylori has been shown to reduce the risk of Duodenal Ulcer recurrence [ see Clinical Studies (14) and Dosage and Administration (2) ]. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [ see Clinical Pharmacology (12.4) and the clarithromycin package insert, Clinical Pharmacology, Microbiology ]. Pathological Hypersecretory Conditions Including Zollinger Ellison Syndrome NEXIUM is indicated for the long term treatment of pathological hypersecretory conditions, including Zollinger Ellison Syndrome. |
Annotated Indication CUIs: C0013295;C0267055;C0017168;C0038358;C0043515;C0018834; |
RXCUIs for this Label: IN=283742 SCDF=606725; SCD=606726;606730; |
Similar Labels: 3cdffcf9-b5fa-4622-9e83-ce29ececcc93;6f650345-0bca-4fe9-96eb-4d7ac80928ec;7aae16cb-addc-468a-be00-6c5be248da29;9af7a792-d38a-4b2a-b5d6-855d2183b029;9b653e01-81f3-49b1-89a2-a56988ad94a3;a373596c-9fb3-426e-bf92-54cdd6dfc3ec;ea79f802-e9ac-480b-91e6-1e3900b11803;f4853677-1622-4037-688b-fdf533a11d96; |
Enter section text here Non Small Cell Lung Cancer (NSCLC) TARCEVA monotherapy is indicated for the treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer after failure of at least one prior chemotherapy regimen [see Clinical Studies ( 14.1 )]. Results from two, multicenter, placebo controlled, randomized, Phase 3 trials conducted in first line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting [see Clinical Studies ( 14.3 )]. Pancreatic Cancer TARCEVA in combination with gemcitabine is indicated for the first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies ( 14.3 )]. |
Annotated Indication CUIs: C0007131;C0346647;C0346976; |
RXCUIs for this Label: IN=337525 SCDF=477321; SCD=603203;603206;603208; |
Similar Labels: 5783976b-0862-44e5-9b19-0f41d236d5c3;57bccb29-1c47-4c64-ab6a-77960a91cc20; |
Herpes Simplex Infections in lmmunocompromised Patients Acyclovir Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV 1 and HSV 2) in immunocompromised patients. Initial Episodes of Herpes Genitalis Acyclovir Injection is indicated for the treatment of severe initial clinical episodes of Herpes Genitalis in immunocompetent patients. Herpes Simplex Encephalitis Acyclovir Injection is indicated for the treatment of Herpes Simplex Encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir Injection is indicated for the treatment of neonatal herpes infections. Varicella Zoster Infections in lmmunocompromised Patients Acyclovir Injection is indicated for the treatment of varicella zoster (shingles) infections in immunocompromised patients. |
Annotated Indication CUIs: C0008049;C0008049;C0019342;C0276226;C0019348;C0019372;C0019360; |
RXCUIs for this Label: IN=281 SCDF=377143; SCD=248108; |
Similar Labels: 2be0c5c9-e52d-4840-bbb4-a0fd6116661a;926efc9b-9126-4855-b76b-a58bd68b42d4;cb64dfab-52ee-4312-bc9c-c3d04efe9109; |
Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes Ramipril capsules are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, Stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of Myocardial Infarction, Stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid lowering therapy). hypertension Ramipril capsules are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using ramipril capsules, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that ramipril capsules do not have a similar risk. (See WARNINGS. ) In considering use of ramipril capsules, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non black patients. (See WARNINGS, Angioedema. ) |
Annotated Indication CUIs: C0027051;C0038454;C0020538; |
RXCUIs for this Label: IN=35296 SCDF=373748; SCD=198188;198189;261962; |
Similar Labels: 00bdb48f-8b8f-4cc5-bb63-77213f2279cb;2f528bdb-66c3-45d4-9d37-63c093bfd5b5;8b59207a-ea5c-4697-a8b6-94c3015a00de; |
ZOVIRAX Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older). |
Annotated Indication CUIs: C0019345;C1274321; |
RXCUIs for this Label: IN=281 SCDF=377568; SCD=141859; |
Similar Labels: 04af8c80-d0ff-49b0-bc82-8c644eacf067;0da14760-1131-4936-9a42-c40fc4db5cd0;125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2;4f610abd-d22e-464a-b463-e86a09d7bdcb; |
Hyperlipidemia and Mixed Dyslipidemia CRESTOR is indicated as adjunctive therapy to diet to reduce elevated total C, LDL C, ApoB, nonHDL C, and triglycerides and to increase HDL C in adult patients with primary Hyperlipidemia or mixed Dyslipidemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non pharmacological interventions alone has been inadequate. Hypertriglyceridemia CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with Hypertriglyceridemia. Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) CRESTOR is indicated as an adjunct to diet for the treatment of patients with Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Homozygous Familial Hypercholesterolemia CRESTOR is indicated as adjunctive therapy to other lipid lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL C, Total C, and ApoB in adult patients with homozygous Familial Hypercholesterolemia. Slowing of the Progression of Atherosclerosis CRESTOR is indicated as adjunctive therapy to diet to slow the progression of Atherosclerosis in adult patients as part of a treatment strategy to lower Total C and LDL C to target levels. Limitations of Use The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined. CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias. |
Annotated Indication CUIs: C0004153;C0242339;C0020445;C0020473;C0020557;C0020479; |
RXCUIs for this Label: IN=301542 SCDF=402354; SCD=859419;859424;859747;859751; |
Similar Labels: 3bf80420-7482-44c0-a117-30793ba89544; |
BENICAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=321064 SCDF=378991; SCD=349373;349401;349405; |
Similar Labels: 370faf80-e054-4b14-b4b3-a7b32d61a4ac;4a9c6e0e-72dd-4ed4-a8bb-8a6aee506681;8c07a4af-dd56-40e4-bd27-dcc0112f6f99;b91de288-ed7b-4b8d-b4d8-b84055bd501a;d4b8a490-d96f-414e-b020-9460625c40ef; |
Dipyridamole is a coronary vasodilator and is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately |
Annotated Indication CUIs: C1956346; |
RXCUIs for this Label: IN=3521 SCDF=376683; SCD=309953; |
Similar Labels: c76c3c6f-c3e0-4e35-ab01-5468585e0d9d; |
Hypertension Ramipril capsules are indicated for the treatment of Hypertension. They may be used alone or in combination with thiazide diuretics. Heart Failure Post Myocardial Infarction Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril capsules to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure related hospitalization and progression to severe resistant Heart Failure [ see Clinical Studies ( 14.3 ) ]. |
Annotated Indication CUIs: C0018802;C0020538;C0027051;C0018802; |
RXCUIs for this Label: IN=35296 SCDF=373748; SCD=198188;198189;261962; |
Similar Labels: 2aa98b7c-ce62-41c0-90a7-091bb9599c7a; |
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. |
Annotated Indication CUIs: C0035854;C0009766;C0339289;C0010543;C0013604;C0153027;C0021368;C0022081;C0259799; |
RXCUIs for this Label: IN=3264 SCDF=371723; SCD=309692; |
Similar Labels: 0de5bcce-0cc2-4b49-bd0d-714f1c7ec3bf;580b36d2-1400-4096-aff1-cbc1f6d0ad4c;6bdcefbe-51e3-4ca4-afda-5aeca7b6fa73;a0aa9dc9-265c-4dd6-9b03-276a47217839;a2c2385e-74a8-4a18-92ec-be8a1380e13a;b61aec30-66c0-4abe-a8ad-2d98d88f21b8;c7700945-e498-4f01-9719-83cee899860d;d51402de-6021-4dc0-86ed-328d159af4f8;de0c3d8a-8115-4283-b420-018282195684;ea3ddaa3-bd52-4160-9991-f17eda28f3d5;ecd69437-dd1a-453b-991d-5c5f277a3abd; |
Dipyridamole injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronary arteriography and dipyridamole injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. The specificity (true negative divided by the number of patients with negative angiograms) was about 50%. In a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests was almost identical. |
Annotated Indication CUIs: C1956346; |
RXCUIs for this Label: IN=3521 SCDF=376683; SCD=309953; |
Similar Labels: 02e40b4e-80bb-4456-9d16-6f8a2f7ec5f0;6093dcd9-82d2-414f-8507-eda22c14f626;8D589FED-78C4-41F8-3F89-468A367A6C79;af761b27-1df6-4d2f-a621-8b9950538e1c; |
Dextroamphetamine sulfate is indicated In Narcolepsy. In Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. |
Annotated Indication CUIs: C1263846;C0027404; |
RXCUIs for this Label: IN=3288 SCDF=371751; SCD=884520;884532; |
Similar Labels: 421cf8e0-ef59-4a19-9d1c-e1ec6596f32b;5bc88dc0-b6b2-4c3f-8ecb-03e41b085e1d;6b8c97ac-c83c-4a1f-a33c-121239253abf;967951a7-cb68-45b5-b94d-1aad5b0cd025;BD31F331-DBAE-4908-955C-AB817E97DD3C;Bed3c03f4-2829-423f-a595-dc09c9cc0e40;b2ad8d2b-ed94-43cd-95ea-85e91d997f26;e05cf690-d45a-4696-a1bf-40c9350cc084;ec2d13f3-d14f-47e4-abe9-7763f95a8e94; |
Hypertension Ramipril capsules USP are indicated for the treatment of Hypertension. It may be used alone or in combination with thiazide diuretics. Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes Ramipril capsules USP are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, Stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of Myocardial Infarction, Stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet, or lipid lowering therapy) [see Clinical Studies ( 14.2 ) ]. |
Annotated Indication CUIs: C0020538;C0027051;C0038454; |
RXCUIs for this Label: IN=35296 SCDF=373748; SCD=198188;198189;261962;845488; |
Similar Labels: 06fff633-04cb-4217-a9c5-e6337fc90f82;0fc34cd8-86e6-4034-73bd-4263a68ba046;36b586cc-94f5-5264-6eb3-569c7356b24b;9d008401-4746-4dc5-94ab-4462f959fb73;ef252592-017a-4e57-92bc-d03994241e85; |
Major Depressive Disorder Paroxetine is indicated for the treatment of Major Depressive Disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM III category of Major Depressive Disorder (see CLINICAL PHARMACOLOGY Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine in maintaining a response in Major Depressive Disorder for up to 1 year was demonstrated in a placebo controlled trial (see CLINICAL PHARMACOLOGY Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient. Obsessive Compulsive Disorder Paroxetine is indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) as defined in the DSM IV. The obsessions or compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. The efficacy of paroxetine was established in two 12 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM IIIR category of Obsessive Compulsive Disorder (see CLINICAL PHARMACOLOGY Clinical Trials). Obsessive Compulsive Disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego dystonic and or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. Long term maintenance of efficacy was demonstrated in a 6 month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder Paroxetine is indicated for the treatment of Panic Disorder, with or without agoraphobia, as defined in DSM IV. Panic Disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and or a significant change in behavior related to the attacks. The efficacy of paroxetine was established in three 10 to 12 week trials in Panic Disorder patients whose diagnoses corresponded to the DSM IIIR category of Panic Disorder (see CLINICAL PHARMACOLOGY Clinical Trials). Panic Disorder (DSM IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Long term maintenance of efficacy was demonstrated in a 3 month relapse prevention trial. In this trial, patients with Panic Disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY Clinical Trials). Nevertheless, the physician who prescribes paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient. Social Anxiety Disorder Paroxetine is indicated for the treatment of Social Anxiety Disorder, also known as social phobia, as defined in DSM IV (300.23). Social Anxiety Disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of paroxetine was established in three 12 week trials in adult patients with Social Anxiety Disorder (DSM IV). Paroxetine has not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY Clinical Trials). The effectiveness of paroxetine in long term treatment of Social Anxiety Disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well controlled trials. Therefore, the physician who elects to prescribe paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Generalized Anxiety Disorder Paroxetine is indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of paroxetine in the treatment of GAD was established in two 8 week placebo controlled trials in adults with GAD. Paroxetine has not been studied in children or adolescents with Generalized Anxiety Disorder (see CLINICAL PHARMACOLOGY Clinical Trials). Generalized Anxiety Disorder (DSM IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. The efficacy of paroxetine in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8 week acute treatment phase while taking paroxetine and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo controlled trial (see CLINICAL PHARMACOLOGY Clinical Trials). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). |
Annotated Indication CUIs: C1269683;C0028768;C0024517;C0030319;C0270549;C0031572; |
RXCUIs for this Label: IN=32937 SCDF=378925; SCD=312241;312243;312244;314199; |
Similar Labels: 027c7db2-2a36-477f-90bf-608ff3a0e14e;040d8193-0ca7-33cd-e300-44bb5b5ee0e4;07f245c5-fcb0-3008-d69e-10290cadbfa6;08320ea3-8f93-6f04-5d1c-f69af3eb5a81;087ff0d3-1761-47ea-a8c1-7c4cb679af97;0a580de2-95d2-49b6-a1e2-6daf70f1f8c8;0d4fb45b-e45b-4519-96a3-a8a106450f87;0fb2e3cc-b9b5-48a6-b487-1e558dfd56db;16348d76-055f-4a7a-9de9-00144c9ee339;21b3b8a2-bfed-4945-954d-6a42ea61888f;326e8ab0-6886-4749-9544-885b37070051;32fd11aa-2996-496d-ac3b-76a6afe22e3c;40226242-da82-4dd7-bca2-eebb14501264;40dcf270-64bb-bca0-db08-6b233a3430f8;42646d8c-2c00-4575-b215-bad0789a1ce0;450eb95f-7650-4050-9d7b-4c68d7a16fa3;49d3b871-f9fd-4d58-8405-8682c0c6e238;4a765347-d687-4af1-a33f-fbff972c6252;555c3588-1fc0-490b-8ccf-bee553b0496a;590CD4BB-C1BD-4CF1-893A-1E418621EED4;605c1d23-c97c-4ea4-92d0-fed351de9d2e;619e10bb-6e5d-4ec3-a85a-6270965f5389;65ee7ef8-cc68-41d1-cc8b-c01a056409a9;6c47a65b-2665-4391-ad69-25c4f5a8b010;6c4d4603-190a-496f-a40f-bc09853b9820;6d5fcdb2-4d84-4b20-87e3-58a43e567500;7b9e9d36-9b7d-4d47-8d8a-d37da85e7b24;821309e9-249a-4eac-a20c-e1d9978a82d7;84b1b1f0-d375-4fda-99af-9487f8ef50c7;8725c835-443a-474a-98b9-7d23991a161f;89dd7e24-85fc-4152-89ea-47ec2b48a1ed;922d17f7-58c7-7b82-5f80-b808a9db5da2;9eaec71a-3641-4afd-8d92-91c89d9a6edd;a6bb4f0a-1555-4550-a7a4-99609674b1e7;a73cf8ee-f99b-4972-8939-0d394a527134;a93796a3-56fc-4af6-99ba-f76707c32e5d;b0edc273-fd24-46b4-9e30-ee01277ef98f;b5a8f864-a53d-48d9-aca6-6b64017fb168;beb15c4c-9ad8-4fa4-d28c-cef6ed9871b5;c0acc97d-3d8d-4a7f-8acd-99050b0af2f1;c34e9941-34e8-484f-8f67-829f7cde8642;c702df3b-584f-4a8e-8554-aa611e18ac4f;c9b57101-2455-463d-b8d7-b2316cecd67a;d8a896c2-b0c2-4b44-a4e3-cb6a8ea472ee;e1ea4019-bb66-403c-a3d5-6ae056a59116;e63fe922-b35a-406c-8737-f3f5e6d5a30d;ea2e434b-c25a-4761-a81c-a4a1a0e0d579;f235ee45-9517-45de-8df7-9a06fdb43380;ff7c7e20-c9ee-4693-beaa-7ac532d5c4b7; |
PERSANTINE tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement. |
Annotated Indication CUIs: C0032787; |
RXCUIs for this Label: IN=3521 SCDF=371917; SCD=197622;309952;309955; |
Similar Labels: 004bada0-dbf7-4a94-8792-6833d7eeda2b;0146650f-d6e6-4a9c-8925-415b3c92b0e7;1b82871b-f60b-4485-9a45-026aeb18b484;1d27873f-b29b-4873-954b-bf50544981e7;312aadb1-435c-4aa7-8e46-6506cedacaa0;5ba4d60d-0715-40db-b3f0-1e9d69a29f28;5dab2bdc-8e4c-450a-8a57-7581584e8bd8;93ba8d29-1ac7-fe80-b571-f8c6617c1d49;a18b2af5-7c4a-4b7f-92c7-8a76e34da373;ae7585ec-1280-40fe-b888-613b8a0e6ef6;bb13afb5-d582-40bd-a266-71f2b99e6797;ca68879c-0214-4d7c-93b0-bdaf8ef23f8e;cc41deca-c10f-437d-b639-e5875712f168;dcf785b2-e923-43bf-93bb-00a9501479f4; |
Hyperlipidemia and Mixed Dyslipidemia CRESTOR is indicated as adjunctive therapy to diet to reduce elevated total C, LDL C, ApoB, nonHDL C, and triglycerides and to increase HDL C in adult patients with primary Hyperlipidemia or mixed Dyslipidemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non pharmacological interventions alone has been inadequate. Hypertriglyceridemia CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with Hypertriglyceridemia. Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) CRESTOR is indicated as an adjunct to diet for the treatment of patients with Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Homozygous Familial Hypercholesterolemia CRESTOR is indicated as adjunctive therapy to other lipid lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL C, Total C, and ApoB in adult patients with homozygous Familial Hypercholesterolemia. Slowing of the Progression of Atherosclerosis CRESTOR is indicated as adjunctive therapy to diet to slow the progression of Atherosclerosis in adult patients as part of a treatment strategy to lower Total C and LDL C to target levels. Limitations of Use The effect of CRESTOR on cardiovascular morbidity and mortality has not been determined. CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias. |
Annotated Indication CUIs: C0004153;C0242339;C0020445;C0020473;C0020557;C0020479; |
RXCUIs for this Label: IN=301542 SCDF=402354; SCD=859424;859747;859751; |
Similar Labels: 1a69848d-95d7-41e8-a3a0-aa5367d4f03b;1ff30eb1-95a6-437e-a618-297891c0c03d;4f2f91bb-f119-4e29-8499-f36f436707b3;5dfefed9-5b84-41f7-a8a4-e118f9518d3e;778b1225-3c5d-4683-9888-8b3306a6e49d;a16450f1-77ea-4017-b4ed-a3c5401f9dbf;ab9f816e-df48-4d90-b8ca-98477659531a;bb0f3b5e-4bc6-41c9-66b9-6257e2513512;c5f46f1b-3594-4ff4-b208-a7b9f830e87e;fa54df87-41d5-96a7-07b6-e700b640bc66; |
Diethylpropion hydrochloride tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regiment of weight reduction based on caloric restriction. The usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described (see CLINICAL PHARMACOLOGY ). |
Annotated Indication CUIs: C1281429; |
RXCUIs for this Label: IN=3389 SCDF=371823; SCD=978668; |
Similar Labels: 79b15110-e484-4b84-8947-15653746773c; |
1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML ) Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase. Ph+ CML in blast crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon alpha (IFN) Therapy Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon alpha therapy. Ph+ Acute lymphoblastic leukemia (ALL) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia. M yelodysplastic Myeloproliferative Diseases ( MDS MPD ) Adult patients with myelodysplastic myeloproliferative diseases associated with PDGFR (platelet derived growth factor receptor) gene re arrangements. 1.5 aggressive systemic mastocytosis (ASM) Adult patients with aggressive systemic mastocytosis without the D816V c Kit mutation or with c Kit mutational status unknown. hypereosinophilic syndrome (HES) and or chronic eosinophilic leukemia (CEL) Adult patients with hypereosinophilic syndrome and or chronic eosinophilic leukemia who have the FIP1L1 PDGFR fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and or CEL who are FIP1L1 PDGFR fusion kinase negative or unknown. Dermatofibrosarcoma Protuberans (DFSP) Adult patients with unresectable, recurrent and or metastatic dermatofibrosarcoma protuberans. Kit+ gastrointestinal stromal tumors (GIST) Patients with Kit (CD117) positive unresectable and or metastatic malignant gastrointestinal stromal tumors. Adjuvant Treatment of GIST Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST. |
Annotated Indication CUIs: C1960397;C0238198;C0279543;C1112486;C0005699;C0346421;C0346421;C1960397;C0392784;C1301355; |
RXCUIs for this Label: IN=282388 SCDF=406050; SCD=403878;403879; |
Similar Labels: 211ef2da-2868-4a77-8055-1cb2cd78e24b;93ddb778-854f-4486-adca-4c5f9071a741; |
Multiple Myeloma REVLIMIDin combination with dexamethasone is indicated for the treatment of patients with Multiple Myeloma (MM) who have received at least one prior therapy. Myelodysplastic Syndromes REVLIMIDis indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate 1 risk Myelodysplastic Syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. |
Annotated Indication CUIs: C0026764;C0026986;C0002871; |
RXCUIs for this Label: IN=342369 SCDF=602909; SCD=1242231;602910;602912;643712;643720; |
Similar Labels: 5fa97bf5-28a2-48f1-8955-f56012d296be; |
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events as follows
|
Annotated Indication CUIs: C0002965;C0948089;C0027051;C1704436;C0038454;C0155626;C0022116;C0948008; |
RXCUIs for this Label: IN=32968 SCDF=374583; SCD=309362; |
Similar Labels: 0d3e4f7c-0ce1-4631-a801-e3812f7dd456;19ebf09d-cf0d-4744-a874-a3a9f0b624b4;EDAE8DF1-CAF9-FF72-1304-5AE8B355F8E7; |
Adjunctive Therapy LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic clonic (PGTC) seizures and partial onset seizures with or without secondary generalization in patients 13 years of age. Monotherapy LAMICTAL XR is indicated for conversion to monotherapy in patients 13 years of age with partial seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of LAMICTAL XR have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDs. Limitation of Use Safety and effectiveness of LAMICTAL XR for use in patients less than 13 years of age have not been established. |
Annotated Indication CUIs: C0751495;C0494475; |
RXCUIs for this Label: IN=28439 SCDF=900142; SCD=1098608;1146690;900143;900156;900164;900168; |
Similar Labels: 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09; |
Intermezzo (zolpidem tartrate) sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. Limitations of Use Intermezzo is not indicated for the treatment of middle of the night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. |
Annotated Indication CUIs: C0917801; |
RXCUIs for this Label: IN=39993 SCDF=836640; SCD=1232194;1232202; |
Similar Labels: 913b6cfe-1fb0-44a8-817a-26374bbce995;962a2fd0-8337-11dd-ad8b-0800200c9a66; |
Guanfacine tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide type diuretics. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=40114 SCDF=372368; SCD=197746; |
Similar Labels: 6fdcebac-0a5a-4858-b0e6-87f77ba53bf1;886e050c-dd22-4f35-ac3b-243f091125c3;9FC0BDC2-5BA2-48DD-AA87-7B0050A2D6CE;a81b956b-f004-4426-ba20-375ccf21eb71;d5c505ea-4886-49c8-a965-3ccc43868cc6;e889f164-a92c-412d-960a-59391e4151fe;fbf22eeb-27f5-46aa-be39-5aef43101369; |
VASOTEC is indicated for the treatment of Hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In clinically stable asymptomatic patients with Left Ventricular Dysfunction (ejection fraction 35 percent), VASOTEC decreases the rate of development of overt Heart Failure and decreases the incidence of hospitalization for Heart Failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using VASOTEC consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that VASOTEC does not have a similar risk (see WARNINGS ). In considering use of VASOTEC, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non blacks (see WARNINGS, Head and Neck Angioedema ). |
Annotated Indication CUIs: C0018802;C0020538;C0242698; |
RXCUIs for this Label: IN=3827 SCDF=372007; SCD=858804;858810;858813;858817; |
Similar Labels: 05c12da2-8814-4afd-bec0-30cf4cdd2b33;08f90170-f53c-4272-92ae-951cf115e271;165703a0-16d0-b7ff-5b66-88f1f7fa0600;23bd6b87-db93-4614-a394-4aa8566ebfb0;27c971a9-5c54-4085-be89-c85e84317294;2B9B72F5-EF3D-8401-BB91-9B75F80A1809;2a6f5fe2-add6-4c6d-b07c-ce707bf49203;308d6011-cffd-49d3-85d1-251dfe77cf5d;34f1c417-40c5-41b6-978c-b57689fe7f3f;39631f1f-5d19-43c1-b504-bf56d991ed97;53ac99fe-8ff3-4a6f-b90e-d602e1019acb;5bfdf9b3-7e3a-4153-a0b8-2f5cc514a16b;5cc4f6f0-8925-81e1-b210-b5a4509a25a9;5d181743-a0fc-4d17-953d-b17a936f9ecc;66234596-162c-4a33-b87e-635839655654;66f5c697-4daa-4b5f-8ee2-40fc70960459;6c8d1720-4129-4d96-b037-b0b82b2d1f2e;78d80ec5-5283-47b5-85bd-315372ef60d9;8abc2534-c20f-4344-8d29-c52b0bfd76b8;AC0289A6-9533-4F8C-B46C-506DCE1B90B5;F103B9F9-E081-419D-A2D8-B86ACDA834DD;bad08ec8-7f9e-47b6-83b9-437e0191080f;d41d6d19-086c-4e17-814c-6fd6f3e81e24;d42cd274-ee43-4be7-b006-24dce0fb6cf6;d59a23ba-9e28-42a3-8bfe-a3742fdfdebe;dd7f12a7-7fe5-470b-b151-6ccf19945638;e31289f1-4b59-418a-a893-c748ce073f6c;e7a26859-167b-48c8-bd36-03ac8191465c;f1ec6ac1-6b94-40bb-a329-9056f201090c; |
Schizophrenia Adults Risperidone Oral Solution is indicated for the acute and maintenance treatment of Schizophrenia [see 14.1 CLINICAL STUDIES ]. Adolescents Due to Janssen Pharmaceuticals Corporation s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with Schizophrenia. Pediatric use information for the treatment of pediatric patients with Schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation s risperidone drug products. Bipolar Mania Monotherapy Adults and Pediatrics Risperidone Oral Solution is indicated for the short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see 14.2 CLINICAL STUDIES ]. Due to Janssen Pharmaceuticals Corporation s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar Mania. Pediatric use information for the treatment of pediatric patients with bipolar Mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation s risperidone drug products. Combination Therapy Adults The combination of Risperidone Oral Solution with lithium or valproate is indicated for the short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see 14.3 CLINICAL STUDIES ]. Irritability Associated with Autistic Disorder Pediatrics Due to Janssen Pharmaceuticals Corporation s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with irritability associated with autistic Information regarding the treatment of pediatric patients with irritability associated with Autistic Disorder, 5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporation s risperidone drug products. |
Annotated Indication CUIs: C0004352;C0853193;C0338831;C0036341;C0349208;C0338831; |
RXCUIs for this Label: IN=35636 SCDF=373790; SCD=199387; |
Similar Labels: cd742c16-c003-4c4c-8fa0-a3b4d0158383; |
For the treatment of superficial ocular infections involving the conjunctiva and or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to gonorrhoeae or trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase producing N.gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants. |
Annotated Indication CUIs: C0015403;C0029076; |
RXCUIs for this Label: IN=4053 SCDF=372063; SCD=310149; |
Similar Labels: 061ddd20-94a6-4e3c-ba84-1ebd8529eea6;1df120f1-778b-4682-9536-2919b782b074;37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a;95b15fd3-84e3-4d27-8744-b56af5e265a0;9b1c6c13-4562-4c8e-a8bb-42493dc5cadb;a0353c10-48c9-4d2a-8047-56ea68ace956;b440cf4c-9d56-4044-9895-1e27df124d06;c7a804bc-dac8-47dc-b7a8-8f2d384652f2;d8b0abac-c32c-4bd0-8247-5c6d6a9fd17f;dc3ee55d-114e-44f2-adb2-fb0c24eba732;e453b459-9aa7-4873-9b62-340a81aa050b;f6a27461-5995-460f-8ae0-4461175be1f0;fd185704-9d91-4999-8c87-bd3cb5085e15; |
Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti inflammatory drugs, including aspirin) induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use. |
Annotated Indication CUIs: C0038358; |
RXCUIs for this Label: IN=42331 SCDF=372941; SCD=311727; |
Similar Labels: 04c42f2b-d049-4892-b003-bdf346cb4ab4;10644068-fa47-4e3b-9e93-f57ebac3dd17;14f73ae3-7d8d-4d10-b668-8bd5adf8032c;150b4d91-7a2a-4c01-877d-bbafd3a7a74e;4ab12da7-5731-4e06-bf1c-bc3f2e711f12;5f6565b7-3d3e-4f5b-bf92-8d9f8002a36a;74ae4775-8190-4bab-93d0-0f209023f973;83554310-3991-4a9d-92f1-d71ccfd0fb3a;a46d05a2-5014-40ff-8f1b-9eca1b0aff3a;a5e5413d-bc22-4ae1-959b-0eb0430dbd38;c4fe14fb-0a43-4c31-9cd6-29eb0d156705;f15b41bd-ed36-4908-aba5-f0a019b7a26e; |
Ambien CR (zolpidem tartrate extended release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient reported assessment in adult patients only) in duration [see Clinical Studies (14) ] . |
Annotated Indication CUIs: C0917801; |
RXCUIs for this Label: IN=39993 SCDF=577086; SCD=854880; |
Similar Labels: 0abb0285-f09c-2110-e570-542dae5fab1a;11a7fa3f-5dd3-4ba6-8a5b-0be321c58dfa;1a32885f-7e42-4558-9142-42d441bcf23d;404c858c-89ac-4c9d-8a96-8702a28e6e76;40f9a7b1-b57b-4e70-b709-e81705e784a7;56060e77-c025-a079-9539-02b649fbf740;5a3ad211-f0a5-4238-8a03-1154fac34c86;68d4314d-1973-481e-806a-da9f5b4baeb0;704066bb-14d8-49d0-9d6e-67d1d4fcb70b;968b5154-3c38-4f20-bbeb-495bcb91cc2b;b1b0085f-d9fe-430a-9bd5-607f607bf7e1;b2c3e941-efa9-4688-b45a-ceb758df717d;b3e19295-1574-4832-936b-bbf41dfce009;fa181279-dce7-4a3f-aba8-b9c2806fdd34; |
FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm. |
Annotated Indication CUIs: C0004096; |
RXCUIs for this Label: IN=41126 SCDF=746765; SCD=896018;896021;896025;896028;896030; |
Similar Labels: 001f22f8-a83d-495f-9196-d0264ef4d76e;ac4fc4e3-f9a6-4176-96a9-a2c78fad96e0;b49ed7c1-123e-4b1d-fea6-0c6839fd9d6a;bcbd136e-7f0d-4da3-9c7b-b2ab75366605; |
Therapy with lipid altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet. Reductions in Risk of CHD Mortality and Cardiovascular Events In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets, USP are indicated to
Simvastatin tablets, USP are indicated to
Simvastatin tablets, USP are indicated as an adjunct to diet to reduce total C, LDL C, and Apo B levels in adolescent boys and girls who are at least one year post menarche, 10 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present
Limitations of Use Simvastatin tablets, USP have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., Hyperlipidemia Fredrickson types I and V). |
Annotated Indication CUIs: C0020443;C0342882;C0342881;C0020473;C0010068;C0242339;C0020557;C0027051;C0020479;C0038454; |
RXCUIs for this Label: IN=36567 SCDF=373888; SCD=198211;200345;312961;312962;314231; |
Similar Labels: 012be6a1-42eb-478c-94c2-3326c40fbe72;0376351b-f1a0-43e5-a0b4-533072c49f39;0a238e82-20d5-45ec-8c13-4725d1065230;0be2e371-1f05-48d7-8f2e-f2024f3305f3;0fcdd59a-906b-43df-9c65-97d8a736b4f1;13c80d46-429e-4007-8f89-eed2ed96eccf;1c0525fc-2d95-4682-a459-7ea4fbe95c72;1c5178c9-270f-4a5b-a52b-68a56972f035;273e5d83-4890-482c-9b69-972c17e786bb;30fbaf9e-01cf-492a-b44f-dc81c17d7647;324a3791-d53e-4716-89cc-9516917407cf;330e35ed-fd6b-4123-864a-a5aa339c24d6;364238c7-11b0-442e-acd9-4a6f21b9d783;3e48217f-8175-4e9b-9fd0-909be4bbba95;4724dbb4-3613-4e6a-948f-a43d34f97f06;48bc36db-f3c2-460a-8d11-13e5c576efeb;4a81b757-0a64-4ed4-86f4-57aeb349105f;4bec3923-6221-4b8b-9a72-872a63680de1;4d19753e-8525-4c67-9657-70ba571f7e74;6336b9ee-a2f3-44cc-ae6a-43a5f68745f6;675d87cb-195c-4d28-8c10-db677e16c656;6e030b0f-8ee6-4b23-9345-7193d4280e88;6fcd7ba3-02cd-41e9-85d5-494961155d3e;7442f35f-74e8-4c35-9666-190a3baad549;79d902bd-c144-4c55-8abc-a07140a62c5e;7e3fc83f-e322-44a1-b0c3-30e6292b92d9;7fce939e-c38e-497f-ba3f-e7b6ba44bfd9;84e3af60-8814-49f6-918e-a4e1c702aa05;871251c0-36a1-4a32-9eab-ff6c1e925ca9;880b3ae3-99e5-4d4c-935c-ee232f1f2a45;881eb80b-712e-4aa2-bd23-290a3e5db6cd;8b3fe1aa-7268-4fb9-aa5a-a865fcbb4155;a0714ce3-bd46-4536-9b1e-83489c368f40;a893d609-a538-4922-98c0-f6089da66149;a92428d1-b8a5-4b3d-965d-50fd333bd743;b1ceb35b-25e0-4b7d-bea0-18099464d168;b1f2911f-f8e1-41c0-9979-cb8d683d2f2f;b3022011-4c11-7516-1f6e-ef606f5954a4;b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5;cb34c06d-bb42-4b3f-aee8-9c559417ed0a;cc8258c3-6265-4b26-a1bf-df6476cc962a;cdb54447-86a5-4924-a7de-ec170f86651d;ce3ac5e8-bdef-d195-e0a0-e1a982008efe;d16d449a-a345-4b7c-8ab5-e18fb37dcb6a;d9a1a7c5-d806-4dbd-a201-5e73790d078b;dcd8802a-bf53-40da-8489-686f4a0610b3;e6d22e3b-9343-408f-9a86-59097f6e8983;e9e50cdb-4cef-4d03-9fb6-973d0c2bf293;ee80603a-7d4c-4172-aef4-286185b69acd;fdbfe194-b845-42c5-bb87-a48118bc72e7;ff4a8eab-17d5-caf4-efba-7e7688202bf5; |
Major Depressive Disorder Venlafaxine hydrochloride extended release tablets are indicated for the treatment of Major Depressive Disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short term trials and a longer term trial in MDD [ see Clinical Studies ( 14.1 ) ]. A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. |
Annotated Indication CUIs: C1269683; |
RXCUIs for this Label: IN=39786 SCDF=452535; SCD=808753; |
Similar Labels: 1f0fa7d6-9309-4cf6-b842-3924ec8aebe7;989705dd-929b-4b62-9ef4-e768f0e366cb; |
Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of fluticasone propionate nasal spray in children below 4 years of age have not been adequately established. |
Annotated Indication CUIs: C0035457;C2607914; |
RXCUIs for this Label: IN=41126 SCDF=746194; SCD=896321; |
Similar Labels: 046bdb61-2ec9-4996-93d9-0680b45693f3;0d9a521b-8314-437c-8c9f-f6188f1134fe;155d0f79-86c2-4096-97f3-5d82762ddc2e;3830675d-b45e-fc97-1f73-674b1fc38c80;3e710670-b72c-4a84-8c52-3ebae8783a32;7c692ed5-959e-4c48-aeec-0799d8979693;9d2750e4-206b-4981-9dfb-da98a0a6e403;b7ea1841-2fb1-48c8-86f9-639893fd1a84;db857d81-4b1e-42b8-972a-5bb8735d60f8;f9edc9b3-12e7-4917-a27c-8dbf6ac654ce;fba9cde2-8fbb-562f-f6e6-b18f8c452248; |
Erectile Dysfunction CIALIS is indicated for the treatment of Erectile Dysfunction. |
Annotated Indication CUIs: C0242350; |
RXCUIs for this Label: IN=358263 SCDF=402452; SCD=402019;484814; |
Similar Labels: 6a8621eb-7415-42a6-9432-630751d34c6b;e7ea978d-00a1-4c60-97bc-bb1d37d776e9;ebddb745-81f9-4b25-8739-b2886032ed26; |
Major Depressive Disorder Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of Major Depressive Disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short term trials and a longer term trial in MDD [ see Clinical Studies (14.1) ]. A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two week period depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Social Anxiety Disorder Venlafaxine Extended Release Tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM IV. Social Anxiety Disorder (DSM IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. Efficacy of venlafaxine extended release in the treatment of SAD was established in short term SAD trials [ see Clinical Studies (14.2) ]. |
Annotated Indication CUIs: C1269683;C0031572; |
RXCUIs for this Label: IN=39786 SCDF=452535; SCD=808744;808748;808751;808753; |
Similar Labels: 35f4790c-1235-49fe-bb9b-842f9e8c09f7;4fabbef0-1838-4f70-aaf9-9550bd5f6204;7027be98-61d6-a986-c9df-60ceef5f7ff0;908bc748-21e3-4f07-bab3-8e3b3da99be0;9136130e-b8fd-4a7c-8eea-e6277622a934;cc3ce063-d28a-4d0b-8735-09193016c49f; |
Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see National Cholesterol Education Program [NCEP] Treatment Guidelines , below). In patients with CHD or at high risk of CHD, simvastatin can be started simultaneously with diet. Reductions in Risk of CHD Mortality and Cardiovascular Events In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin is indicated to
Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles Simvastatin tablets are indicated to
Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH) Simvastatin tablets are indicated as an adjunct to diet to reduce total C, LDL C, and Apo B levels in adolescent boys and girls who are at least one year post menarche, 10 to 17 years of age, with heterozygous Familial Hypercholesterolemia, if after an adequate trial of diet therapy the following findings are present
General Recommendations Prior to initiating therapy with simvastatin tablets, secondary causes for hypercholesterolemia (e.g., hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total C, HDL C, and TG. For patients with TG less than 400 mg dL (< 4.5 mmol L), LDL C can be estimated using the following equation LDL C = total C [(0.20 x TG) + HDL C] For TG levels > 400 mg dL (> 4.5 mmol L), this equation is less accurate and LDL C concentrations should be determined by ultracentrifugation. In many hypertriglyceridemic patients, LDL C may be low or normal despite elevated total C. In such cases, simvastatin tablets are not indicated. Lipid determinations should be performed at intervals of no less than four weeks and dosage adjusted according to the patient's response to therapy. The NCEP Treatment Guidelines are summarized in Table 6 After the LDL C goal has been achieved, if the TG is still 200 mg dL, non HDL C (total C minus HDL C) becomes a secondary target of therapy. Non HDL C goals are set 30 mg dL higher than LDL C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge. The NCEP classification of cholesterol levels in pediatric patients with a familial history of either hypercholesterolemia or premature cardiovascular disease is summarized in Table 7. Since the goal of treatment is to lower LDL C, the NCEP recommends that LDL C levels be used to initiate and assess treatment response. Only if LDL C levels are not available, should the total C be used to monitor therapy. Simvastatin is indicated to reduce elevated LDL C and TG levels in patients with Type IIb hyperlipidemia (where hypercholesterolemia is the major abnormality). However, it has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V) 3 . Figure 2 |
Annotated Indication CUIs: C0020443;C0242339;C0020445;C0020473;C0020557;C0027051;C0020479;C0342879;C0038454;C0020445;C0020473; |
RXCUIs for this Label: IN=36567 SCDF=373888; SCD=312961; |
Similar Labels: 07c99997-31c7-4c03-ae35-49788213b43e;34B56F73-BEA4-4265-8B2A-C57520CF8E70; |
1.1 Treatment of Allergic Rhinitis VERAMYST (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. |
Annotated Indication CUIs: C2607914;C0035457;C0018621; |
RXCUIs for this Label: IN=41126 SCDF=746194; SCD=895968; |
Similar Labels: 4e444ce8-3dca-4a95-8ebf-752da67e80ff;8eaee9bf-91c7-484b-b8b1-b8242198181f;f16a9f33-45ca-4e16-0ebe-157b71abb8df; |
Epilepsy Divalproex sodium capsules (sprinkle) are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium capsules (sprinkle) are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. [see Warnings and Precautions (5.2) , Patient Counseling Information (17.3)] . |
Annotated Indication CUIs: C0014544;C0014553;C0270834;C0036572;C0014553;C0014553; |
RXCUIs for this Label: IN=40254 SCDF=808586; SCD=1099596; |
Similar Labels: 2e4778d8-8798-4da1-bb33-1aa1414b5809;b0f33792-dd96-40cc-a28e-acdcdca2f4b8;c41abc6d-1918-4b35-80cc-2b3c019822d6;ed710c62-8ba6-4f19-b240-3ee73cd03d67;f911748c-fb3a-fe1a-ab2a-4b40455e05ef; |
Akne mycin is indicated for topical control of acne vulgaris. |
Annotated Indication CUIs: C0001144; |
RXCUIs for this Label: IN=4053 SCDF=374382; SCD=238936; |
Similar Labels: 018c94b5-8379-4b08-a18c-fad9c0219c0b;2ad5cf71-bf84-478d-9c9c-5577bcb58ebc;2d14281c-0815-4d91-a161-10c34eee5bd8;3b9a1f4a-2590-4216-a3fd-8bda2b9751db;40edf1bd-42bb-4662-aff6-01fcc133c05d;51709310-195d-4070-87fa-434e2e5e07bd;720512c7-9ea4-40c8-b119-b39a3f9a448b;7a4eeb39-beb4-4554-a5ab-e752887433e1;81312193-82D8-49F8-B381-8FB866B2EC76;992be13e-2409-4799-96ef-731ac3bf3973;9a63da11-01be-4c63-a260-e6bdbb4a7a69;aa993373-f75f-440f-bdae-59892557ba2c;dd64459e-c88f-4ca8-b63b-fb96377a3921; |
MERIDIA is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. MERIDIA is recommended for obese patients with an initial body mass index 30 kg m 2 , or 27 kg m 2 in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kg, and dividing by the patient's height, in meters, squared. Metric conversions are as follows pounds 2.2 = kg; inches 0.0254 = meters. Meridia body mass index chart. |
Annotated Indication CUIs: C0028754; |
RXCUIs for this Label: IN=36514 SCDF=373870; SCD=1294537;1294541;1294545; |
Similar Labels: c0333e62-bb00-4722-27b6-dca6ab4d1eb1; |
Attention Deficit/Hyperactivity Disorder (ADHD) STRATTERA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD four 6 to 9 week trials in pediatric patients (ages 6 to 18), two 10 week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)] . Diagnostic Considerations A diagnosis of ADHD (DSM IV) implies the presence of hyperactive impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM IV characteristics. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months fidgeting squirming, leaving seat, inappropriate running climbing, difficulty with quiet activities, on the go, excessive talking, blurting answers, can t wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive impulsive criteria must be met. Need for Comprehensive Treatment Program STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician s assessment of the chronicity and severity of the patient s symptoms. |
Annotated Indication CUIs: C1263846; |
RXCUIs for this Label: IN=38400 SCDF=378308; SCD=349591; |
Similar Labels: 23c702e2-3abc-4d7d-b88f-a089e2179f42;309de576-c318-404a-bc15-660c2b1876fb;47137273-b9c1-4cb4-99ca-2dab9690b560;6a6964c3-e022-43e3-a88e-45806c5faba8;6f6bea0c-297b-43ff-8960-ecc11243e06e;76b8f7da-7e69-4953-be59-e38397e0fd36;a671ec20-1d70-45e1-9893-025f832444c5;bdab7205-d0ff-41c3-8430-2d399dfaa759;f8f80fca-32b7-4fba-b0ab-e87530bc36b6; |
Erectile Dysfunction CIALIS is indicated for the treatment of Erectile Dysfunction (ED). Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). Erectile Dysfunction and Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED BPH). |
Annotated Indication CUIs: C0005001;C0242350; |
RXCUIs for this Label: IN=358263 SCDF=402452; SCD=402019;403957;484814;757707; |
Similar Labels: 0e747223-2740-4e45-9bef-ae5f7798064a;bcd8f8ab-81a2-4891-83db-24a0b0e25895; |
CUTIVATE (fluticasone propionate) Lotion is indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 1 year of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE Lotion in pediatric patients below 1 year of age have not been established. |
Annotated Indication CUIs: C0011615 |
RXCUIs for this Label: IN=41126 SCDF=577392; SCD=895990; |
Similar Labels: 0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c0;10f6099a-c53c-4b0c-b81e-136c0e9f13d9;3b5de5ca-a947-4815-8968-e09fc985e83c;3c7b3482-e2fd-4857-9394-a47fd7f4c47b;657aee47-558f-4634-a566-fc81dab2fabc;78e056e2-d39e-4d20-9ab2-332bd6973619;9953df12-a2b4-4d22-b204-746fc29f7a5f;cc79e200-ce69-4ffd-be5b-8c1a6bb88c5c; |
Seasonal Allergic Rhinitis Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with Seasonal Allergic Rhinitis in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 2 to 5 years) with Seasonal Allergic Rhinitis is approved for UCB Inc. s levocetirizine dihydrochloride drug product. However, due to UCB Inc. s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Perennial Allergic Rhinitis Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with Perennial Allergic Rhinitis in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with Perennial Allergic Rhinitis is approved for UCB Inc. s levocetirizine dihydrochloride drug product. However, due to UCB Inc. s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Chronic Idiopathic Urticaria Levocetirizine dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of Chronic Idiopathic Urticaria in adults and children 6 years of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with Chronic Idiopathic Urticaria is approved for UCB Inc. s levocetirizine dihydrochloride drug product. However, due to UCB Inc. s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. |
Annotated Indication CUIs: C0578870;C0035457;C0018621; |
RXCUIs for this Label: IN=356887 SCDF=402343;759919; SCD=855168;855172; |
Similar Labels: 2965ef46-18db-4615-9dce-bfb0f0b3366a;2bc07580-0833-fbe4-ead0-f9c52cf08af5;2f42fc80-ae39-4301-b140-36e59d71666e;4f43d057-cba8-4366-86ba-4be361e4c71f;60ae7e0e-281c-40a3-a0d3-259b843ddaaa;8d416349-161d-4232-b6b4-e75214ea4841;c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a; |
Pulmonary Arterial Hypertension ADCIRCA is indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). |
Annotated Indication CUIs: C0152171; |
RXCUIs for this Label: IN=358263 SCDF=402452; SCD=402019; |
Similar Labels: ff61b237-be8e-461b-8114-78c52a8ad0ae; |
Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM III or DSM III R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo controlled trial (see CLINICAL TRIALS ). Nevertheless, the physician who elects to use venlafaxine tablets venlafaxine hydrochloride extended release capsules for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C1269683;C0221480; |
RXCUIs for this Label: IN=39786 SCDF=374285; SCD=313580;313582;313584;313586;314277; |
Similar Labels: 04b9b820-228c-d7f8-519d-d65feb897199;04c95282-2e10-4ab5-baf2-62d44dd8f22f;0804aaf5-de2d-4e38-915d-4b3c0da379d4;09feeadb-d4e6-47dd-8d1e-b03052a9cc5d;106d0d7b-925b-74e7-83cb-562144ce1f92;185d90ab-1ba4-dd59-0565-e35f0fd39a2d;1be1be3a-304b-4e31-8732-335247029191;28f12fa3-b5ef-41c7-a750-32c80d8881cf;2a84b9b5-cb10-46b7-b5a3-2cd9b4ffb0f3;2bb09fc1-1c0a-4586-9af9-5aed8d4322db;2c3f8268-ef43-d58c-7da6-dd44f8feb3be;2c7742aa-7722-4c12-9e4b-b4c3ca5a7fb0;2e8f0889-57ca-498a-8e91-b8a24bbe47fd;3942d30d-827b-46c7-8454-3020d5d7865d;435cf21c-b051-49f2-8428-fa7920f2c6c3;49bef388-71ff-43b1-87a8-9fd506a0e63e;4c401522-0108-49cb-8a41-fb5ad4dd0fb1;51334651-7a7f-4653-bf9d-d5be04fd902d;5351fe67-17d9-42ec-9e8b-6585fdb9e29e;53b73f2a-d839-41b5-bc9c-aeb3e9dba304;53c3e7ac-1852-4d70-d2b6-4fca819acf26;55889b3d-74c9-4638-9a14-6a4ca3a99f7f;6148707f-625f-47be-b4bf-b5966078675d;62c02cdb-ea65-41ff-a531-4d9ea498f705;6be70efb-322e-4e65-9851-a7d167065dd8;72efad5f-0909-46a5-aa13-ac24fe015fe6;7f3aa63e-402a-41a2-b570-977795010ea8;83cb4d74-d75e-4aad-9bae-a09a5a789806;84034bf7-0ba3-060d-73f5-275de6aff417;85d3ce8b-8966-45d9-bdaf-f6f0475096e1;8FBA17DA-573A-425B-B1D7-7DDEEEF3C957;8a2302ca-5c25-4d2d-9ffe-320080934aab;8d06eb3d-16bd-495a-b58f-90877f3d5188;9a30e1b5-272b-4109-ad6c-a3c9a895822f;9b5885cc-ef96-4081-8975-9febc6772dc0;9de97bb7-36e8-4126-bede-d48375da15df;a4e1d3bc-4e97-4ff0-9e30-22a699c96072;a5e32167-9ee0-4fbb-8577-c67fbc794d78;a821ed7b-53cf-438d-b8ab-6d7ac1c08912;b23637e5-d37f-41b5-ba76-fc053e903bc2;b379b413-5d66-4adb-8521-3978f10bbd1d;b4048138-3b43-4952-9c4d-f9278792f2b5;c32ccd4d-77b4-4451-8c03-ffc6484bc1f3;d84376b8-6071-4738-96d6-182bd323e835;d87fba09-06b6-41a8-867c-a8428fce240e;db64c361-7960-4e86-8c71-5d96a381ae23;e0990ade-320e-4259-8c0e-6d5ef23bc673;e5a31f69-c237-49b7-83a2-d04eebbc30ce;eb28f976-ce74-47e1-7757-c0832c28be75; |
Seasonal Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with Seasonal Allergic Rhinitis in adults and children 2 years of age and older. Perennial Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with Perennial Allergic Rhinitis in adults and children 6 months of age and older. Chronic Idiopathic Urticaria XYZAL is indicated for the treatment of the uncomplicated skin manifestations of Chronic Idiopathic Urticaria in adults and children 6 months of age and older. |
Annotated Indication CUIs: C0578870;C0035457;C0018621; |
RXCUIs for this Label: IN=356887 SCDF=402343;759919; SCD=855168;855172; |
Similar Labels: 371ca86d-7ffd-4f20-b6c6-af0a9ff7362f;7a6d9491-a4c9-497c-9c17-4037c46f9e6a;88313e5f-9426-4aac-8909-d56bde6f584f;ccfd9a79-f3fd-4786-b7ba-e4906089d8f7; |
Schizophrenia RISPERDAL CONSTA (risperidone) is indicated for the treatment of Schizophrenia [see Clinical Studies (14.1) ] . Bipolar Disorder RISPERDAL CONSTA is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder [see Clinical Studies (14.2 , 14.3) ] . |
Annotated Indication CUIs: C0005586;C0853193;C0036341; |
RXCUIs for this Label: IN=35636 SCDF=402331; SCD=402010;402011;402012;706822; |
Similar Labels: bb34ee82-d2c2-43b8-ba21-2825c0954691; |
Fluticasone propionate ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. |
Annotated Indication CUIs: C0037274; |
RXCUIs for this Label: IN=41126 SCDF=372254; SCD=895487; |
Similar Labels: 04d2a675-a9c6-4dce-b17d-dfc86865f8e1;16985600-3f81-4d51-8bf7-0cbbd89856a1;255e71b4-9e24-4ad2-93f6-0a0ade71d823;e7ef2aaf-749c-66c9-2bdf-7214ab00060e;ff96762d-a841-4558-befd-d14761bbe6fc; |
Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis. |
Annotated Indication CUIs: C0029408; |
RXCUIs for this Label: IN=41493 SCDF=372754; SCD=152695; |
Similar Labels: 040fecdb-68cf-4967-90ce-c2130b520615;39bfb379-ef90-4a87-8b22-42ab0906785d;4EC9BF84-D0B0-4092-8E3D-C67CCFB2780B;5afa7fd7-3362-4cab-9630-2d9db708165c;64217ed0-7b53-4b8b-8e53-2b645640ab22;6513e46b-3229-685b-c83b-2209454fae71;6baa5e7f-c884-45dd-8dd7-4c3b4742eb0f;6ed06682-7507-4c11-a782-42e694c21b53;8FAD5C7C-15F1-4979-99A6-BAD75D45C393;A10CE6D9-0AC9-4EAF-8C2E-56DDC490D1F0;F6C6D183-0A63-0D25-5CD7-43A2D0D63BEB;c8683c04-0e54-4e97-992b-55c2d605793c;cb44be1a-a5c4-406f-9a2c-1835a2c3f0e0;fe8480c4-b176-45ae-b4d6-fa59912fe286; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of ERY TAB and other antibacterial drugs, ERY TAB should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. ERY TAB tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below Upper Respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes ; Streptococcus pneumoniae ; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.) Lower Respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae . Listeriosis caused by Listeria monocytogenes . Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella Pertussis . Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of Pertussis in exposed susceptible individuals. Diphtheria Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma In the treatment of infections due to Corynebacterium minutissimum . Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae Erythrocin Lactobionate I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of Acute pelvic inflammatory disease caused by gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis . When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum . Primary syphilis caused by Treponema pallidum . Erythromycin (oral forms only) is an alternative choice of treatment for Primary syphilis in patients allergic to the penicillins. In treatment of Primary syphilis, spinal fluid should be examined before treatment and as part of the follow up after therapy. Legionnaires' Disease caused by Legionella pneumophila . Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of Rheumatic Fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis). 3 Erythromycin is indicated for the treatment of penicillin allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of Rheumatic Fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of Rheumatic Fever). 3 |
Annotated Indication CUIs: C0037278;C0009763;C0032285;C0149959;C0008149;C0012546;C0014752;C0013370;C0023860;C0043167;C0035243;C0018081;C0007939;C0035436;C0311389;C0031350;C0036689;C0040425; |
RXCUIs for this Label: IN=4053 SCDF=372060; SCD=310155;310157;315090; |
Similar Labels: 04775721-ab87-4b66-808c-d67a21032385;04aa620e-90a3-4f22-91ee-b2de9f41e54c;14a886f7-b5e3-48ec-b77f-14b0a577d802;17f33d19-9a87-4530-a477-42848f3d3e0c;216a7517-bf53-48d1-9613-78c9536c4ebf;23a0564e-dca9-41bc-b2c7-0461169f65f9;28a270f4-f713-4d88-b83a-f5b5e9b26746;3bb441fb-3c40-45d6-bb10-c761cc8e83b0;3e53be82-0c32-4f3f-46aa-e6dc15e09e30;3e823928-c853-4617-acad-21b27174aa7b;41D549E0-23AE-4D86-B92C-2ACBDEEACA66;51841d8c-5625-448d-8184-940023aebd02;553240ad-2b80-4ab4-b229-8eaf5e755a84;63ab97a3-5f44-4881-f38b-960b4f474790;65907167-2ee1-4c8c-a950-87ac35e9f5a3;6c789378-0ec7-4874-aa42-e3418e859f86;6d8c343b-30d9-4cdb-8f55-2a20983a71c1;9231d2fa-2e91-4eef-afa3-7515bc34df0b;98C0C097-C253-4CC2-939E-6C172752D394;98d84849-4796-4483-9fe7-bf617fcd555f;C3F7CD94-D842-4F6B-A582-A38C751A790A;a0c0811e-9b05-4434-21a3-a25ebb27681f;a96c405f-bd70-4bb4-719e-ac6a79dcc213;adea2968-68fa-435e-9c8c-dfa0f9903b00;b455bbdb-a3f1-470f-aa5f-ed83ac2e228d;c9b4d3f9-72f3-403b-9399-9426d3555350;ca1326d6-c5c6-4572-96b6-e56cd944799c;d19e99aa-90ac-4777-a3c9-69620724bbb1;dc8ceafe-9597-4de6-968d-43c87a261162;ddd9ad9a-fc60-409a-a2b3-be51482ef751;e142a363-a8b8-40b9-ae9d-28777367e718;e3e27c8f-64d5-4e6e-bb2d-5dd3a2e3daa1;e7dd481b-5c2a-412e-86df-dfe1376ce38c;e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4;e864096e-8581-48a4-9459-956e2b366181;fda44eb6-7901-4b80-ba0b-216f6cacf3fd; |
Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions (5.1) for statement regarding fatal hepatic dysfunction. |
Annotated Indication CUIs: C0270834;C0036572;C0014553; |
RXCUIs for this Label: IN=40254 SCDF=808657; SCD=1099687; |
Similar Labels: 05e16c10-ff0a-4238-8181-f3e84379ed6a;0b24089f-4c7f-4fee-9a86-89f783b76514;4067a52d-c3fa-4531-8e4f-9675e494065f;5850bfd4-df74-44fb-aef5-ea3fa7c075ee;6541ab19-3cfc-4786-9cfe-0455f428edb5;6a7f6c20-d878-409f-aadb-8c5c63df61d0;6b4331f5-4475-417a-6a9d-09c2f8334235;7386b72a-de47-48e3-b070-8bd9437c2230;740a1ae9-19f0-4a0f-a431-e4b9ffb9381a;7af84664-7e3b-43f3-a43e-beba36ffb739;7d5cb52e-37dd-4dfa-a6f4-09f9548846c6;84bbc23d-9bd3-4d48-9b64-d6eef64214b4;9d3b0fc6-c69f-4110-a606-c0b5d690b5e5;9fbfe4dc-c4df-4911-a440-099c860cb923;a3dcab36-b9df-421a-8c24-bf6ef4f9d7a8;bcf57b31-4811-4104-82b3-46fb91a53ee0;caf12ea3-06c8-44c1-9e89-3ecaff89a22b;cef3e335-5891-412f-89c4-79fcd2f145b7;d378200e-b31a-4b25-bde1-871f944830e5;d49fc909-1e02-4e51-b957-45540d678dde;da030cbb-40f6-4805-9883-0d8945afbcc3;dc5c6650-7ee8-4357-b037-08cd265b985a;ec559356-75a3-423b-9e8c-3ff88290a98a; |
(OA) MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies (14.1) ]. Arthritis (RA) MOBIC is indicated for relief of the signs and symptoms of Rheumatoid Arthritis [ see Clinical Studies (14.1) ]. Rheumatoid Arthritis (JRA ) Pauciarticular and Polyarticular Course MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [ see Clinical Studies (14.2) ]. |
Annotated Indication CUIs: C0003864;C0553662;C0003873;C0029408; |
RXCUIs for this Label: IN=41493 SCDF=372754;597405; SCD=152695;311486;597406; |
Similar Labels: 676e73fb-51d2-449a-8749-1a7bcc257b11;6f6f6cc7-0833-410c-8889-206addebbfa3;72d1ad20-a10d-4c1e-8a4a-a125426d400f; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Travelers Diarrhea XIFAXAN 200 mg is indicated for the treatment of patients ( 12 years of age) with travelers Diarrhea caused by noninvasive strains of Escherichia coli [ see Warnings and Precautions ( 5 ) , Clinical Pharmacology ( 12.4 ) and Clinical Studies ( 14.1 )] . Limitations of Use XIFAXAN should not be used in patients with Diarrhea complicated by fever or blood in the stool or Diarrhea due to pathogens other than Escherichia coli . Hepatic Encephalopathy XIFAXAN 550 mg is indicated for reduction in risk of overt Hepatic Encephalopathy (HE) recurrence in patients 18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed. XIFAXAN has not been studied in patients with MELD (Model for End Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] . |
Annotated Indication CUIs: C0011991;C0019151; |
RXCUIs for this Label: IN=35619 SCDF=451309; SCD=429662;856664; |
Similar Labels: 523f0320-cc73-445a-a48d-7a181c182307;c5e8e2fd-7087-4b78-9181-cc259c0be2f1; |
HYTRIN (terazosin hydrochloride) is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with HYTRIN. The long term effects of HYTRIN on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. HYTRIN is also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta adrenergic blocking agents. |
Annotated Indication CUIs: C1704272;C0020538; |
RXCUIs for this Label: IN=37798 SCDF=374033; SCD=260376;313215;313217;313219; |
Similar Labels: 1bdcf20c-6806-495c-9505-1b64d66e5405;24a4243f-0855-44c1-bb78-ba6f14b273f9;24ce46de-cf8f-401f-8bb6-490b296513c5;2795c42c-8aad-41bd-f386-f075505d4e8b;2cfe38fe-f16c-4dbd-a237-15e0d12ef3ef;30503dfd-03bd-46d8-8170-d9ed096fd71d;43CBC779-48D1-48FB-F09E-2D1722B4046D;43e92495-2cf2-46dd-a80c-f0c3c88c7b73;66abc5e3-4a7c-447a-8daa-91b872b88094;68877160-c88e-4b4e-a61d-abd4dff96742;6c26db9b-f16c-4797-b6b1-bc51bf2649b5;9d8fd052-b478-447e-a884-74fcd21275bb;EE7A527D-290E-437D-BB9D-1617AFE1C1AF;a00604ff-041d-4ad4-a3bb-d0911bf0727e;a9fdefac-0145-4d34-ab25-074bc534afaf;bcd2cf96-c69f-4600-8d24-245de0f88a64;cc7b252f-551d-443b-8845-307da7394068;d156295e-43aa-4456-9c2c-b6a367c385de;d971811c-d327-4e63-808c-8d553ee471e7;fbfca9d7-bd04-4148-91c7-02b37e839d28; |
Acute Treatment of Migraine Attacks and Cluster Headache ALSUMA (sumatriptan injection) 6 mg 0.5 mL is indicated for the acute treatment of Migraine attacks, with or without aura, and the acute treatment of Cluster Headache episodes. |
Annotated Indication CUIs: C0009088;C0149931; |
RXCUIs for this Label: IN=37418 SCDF=727338; SCD=727339; |
Similar Labels: 55f21004-9ce6-4648-94d9-73ab2c7873e8;6a4c0c2f-497d-4c5c-84c4-9ab42780cbde; |
Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of Multiple Sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. The efficacy of TYSABRI beyond two years is unknown. Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate Multiple Sclerosis therapy [see Boxed Warning , Warnings and Precautions ( 5.1 ) ]. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied. Crohn's Disease (CD) TYSABRI is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's Disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF . TYSABRI should not be used in combination with immunosuppressants (e.g., 6 mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF [see Boxed Warning , Warnings and Precautions ( 5.1 ) ]. |
Annotated Indication CUIs: C0010346;C0026769; |
RXCUIs for this Label: IN=354770 SCDF=477487; SCD=477484; |
Similar Labels: 6fa00cb8-4229-4770-9d2a-d4a8542b3180; |
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The efficacy of INTUNIV was studied for the treatment of ADHD in two controlled monotherapy clinical trials (8 and 9 weeks in duration) and one controlled adjunctive trial with psychostimulants (9 weeks in duration) in children and adolescents ages 6 17 who met DSM IV criteria for ADHD [ see Clinical Studies (14) ]. The effectiveness of INTUNIV for longer term use (more than 9 weeks) has not been systematically evaluated in controlled trials. A diagnosis of ADHD implies the presence of hyperactive impulsive and or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM IV characteristics. Need for Comprehensive Treatment Program INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. INTUNIV is not intended for use in patients who exhibit symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational vocational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe INTUNIV will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms and on the level of functional impairment. |
Annotated Indication CUIs: C1263846; |
RXCUIs for this Label: IN=40114 SCDF=862005; SCD=862006;862013;862019;862025; |
Similar Labels: b972af81-3a37-40be-9fe1-3ddf59852528; |
Glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non insulin dependent diabetes mellitus (NIDDM; type II), formerly known as maturity onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. In initiating treatment for non insulin dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible. If this treatment program fails to reduce symptoms and or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glipizide must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone also may be transient, thus requiring only short term administration of glipizide. During maintenance programs, glipizide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgements should be based on regular clinical and laboratory evaluations. In considering the use of glipizide in asymptomatic patients, it should be recognized that controlling blood glucose in non insulin dependent diabetes has not been definitely established to be effective in preventing the long term cardiovascular or neural complications of diabetes. |
Annotated Indication CUIs: C0011860;C0011849;C0020456; |
RXCUIs for this Label: IN=4821 SCDF=372320; SCD=310488;310490; |
Similar Labels: 06505b04-656c-47ef-83ba-ab977bdcaaf4;0a280a88-5973-4d0f-9b25-9be0c96e49c7;3030da52-4e59-44d0-9d62-4b27e38e7e91;36199637-6267-43d6-9304-d77e8948c4fd;37A18BD1-034F-4366-8323-EC4E1C52AC1E;46056e8c-dc64-42e2-8c7f-0b82fbf63d4d;5af9cea1-f70c-48af-b640-fb1048ca6beb;653e1ec7-2ffc-4876-b200-36cedf187385;83cac6c1-372e-4063-95f9-87740e05b19c;a9abe8f4-0b0b-42f7-b3d7-c678a9fcf39f;ab0646e3-3db2-4dff-8991-c796a5c899dc;ad55dfd7-ffb5-478a-aa84-1009fa921e22;c829b7bf-1a12-44b2-b5ce-fd44a1f0d333;e1f70f24-1a4d-4861-9917-859bca58b865;e253ec37-78bb-4168-b630-2b7e33607f9d;e9f904fa-5709-48df-a4cd-4604b656b1a1;f19783e8-76bd-4403-b348-b30b449bb615; |
For the prevention and treatment of portal systemic encephalopathy, including the stages of hepatic pre coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal systemic encephalopathy, Lactulose has been given for over 2 years in controlled studies. |
Annotated Indication CUIs: C0019151; |
RXCUIs for this Label: IN=6218 SCDF=378092; SCD=391937; |
Similar Labels: 00c42c5c-d19e-4130-aa08-a8bbd47d3e5b;2a2eee86-273e-4718-8f78-34f15e193040;67e975ca-cc79-237d-6c29-4653c222e0c8;A9B8BC93-AF0F-44E6-A5F2-FF001542A81F;ff6b4568-1383-46b6-a1c6-385fc31fb210; |
Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. |
Annotated Indication CUIs: C0040517;C0040188;C0260653;C0033975; |
RXCUIs for this Label: IN=5093 SCDF=372377; SCD=310672; |
Similar Labels: 0027b8a3-73bf-4005-a7e3-b035f451a861;0ac0cc44-3924-447d-9051-f84c44312380;2d848e8c-de42-4a09-96f1-a2d250af059d;509d0eb2-b930-4836-9669-dbebf0ac4076;54502f78-7244-454a-9171-4e73127f1456;5913794a-3aad-48ef-89ca-eebc8ae92628;59903eb9-77a2-42b3-ae09-af94ac209d32;82305b49-9fdf-425b-98d7-39c2ac156918;871fc448-dfa7-492b-813c-c37e93e53cdb;913fdc2f-36eb-47e1-aaee-7bfb542d3ed3;ad7d2f17-a4e8-4ebc-9baf-5983ac626782;b37de1e8-066b-49ea-a03a-8103733c6ee3;b488c106-f1ee-4b7b-8516-01162fb929f7;bd2a2749-4f93-400a-a06d-db7b8115ebad;c559b0b0-4087-d12a-e718-c18ccb6811e6;d3ea05de-a49e-4924-8ce8-38978302f266;df0f93db-aa16-4f30-8c49-904d269b36b1;f200975a-530f-47b6-84bf-de425b563ee0; |
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur. |
Annotated Indication CUIs: C0401149;C0009806; |
RXCUIs for this Label: IN=6218 SCDF=378092; SCD=391937; |
Similar Labels: 0f19e4ed-c90a-4330-a7fa-bf911aa98f09;183c0621-d058-4600-9345-2b01d66cb65a;19455240-16b6-4e25-a5c9-a6c965e5ec19;287b0b8b-962b-4f05-b770-5dc9d170d1d0;461ec39f-eeb4-4460-9b5c-62367d47162b;5f1082c8-f21f-44e1-a166-793d355d54d7;6c8f865e-f2f4-4c98-8bad-68f1575e2ed5;7016bd71-c667-46fc-8c56-5023682e8bbe;a61e6ba8-b342-4815-9623-eb0c319ecc74;ba296354-b01c-4b3f-a980-b8a0ac370932;bd4d1c58-4b9b-47c1-a3c7-64f7a827d408;d21e0f18-ea2d-4be0-8f2e-78637126504e;fa13a399-a397-4a2c-b4ae-b152c35439e7; |
CANASA 1000 mg Suppositories are indicated for the treatment of active ulcerative proctitis. |
Annotated Indication CUIs: C2937222; |
RXCUIs for this Label: IN=52582 SCDF=372786; SCD=248420; |
Similar Labels: 357e0e6b-cfbd-454c-82d7-cfc460dc0d68;89d91601-152b-4398-bebe-af1c023e9935; |
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. |
Annotated Indication CUIs: C0011573;C0011570; |
RXCUIs for this Label: IN=5691 SCDF=370680; SCD=835572;835577;835589;835591; |
Similar Labels: 53faac6a-fdb9-4d60-814d-b4aab9c9da58;6e780825-2a66-41fd-a04c-78fa7c4df05e;75bf3473-2d70-4d41-93cd-afa1015e45bb;75c986bd-e51f-4f8c-9590-0df4718d0b9e;93B19AE0-C0A1-4400-9A56-6827939B7E7A;d1dde497-1889-4424-af18-da7ca6459cf3; |
In Anesthesia ROBINUL Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, ROBINUL Injection may be used intraoperatively to counteract surgically or druginduced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non depolarizing muscle relaxants. In Peptic Ulcer For use in adults as adjunctive therapy for the treatment of Peptic Ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. |
Annotated Indication CUIs: C0030920;C0428977;C0700323; |
RXCUIs for this Label: IN=4955 SCDF=372339; SCD=238212; |
Similar Labels: 125a2d5d-0ee6-4bd8-991d-5fbfbe3e7dcb;2ade57bf-4013-4358-9e3b-8b6df7fd4045;38f88829-a226-4810-866c-1b62c47e8aee;3adddbd4-0b17-4312-83a2-a8420caf045e;61767a0d-c94c-44d8-b35c-316a5731a275;62267afe-1a73-4623-984e-646db590ec5b;d82ca14f-2116-4ec1-b497-1c9d6db4d5e7;eac7ff63-9fa3-4774-8a83-36353dd4cd7a;fe52214b-fe89-4215-a43b-5f9a85950fa9; |
LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. |
Annotated Indication CUIs: C0009324; |
RXCUIs for this Label: IN=52582 SCDF=372784; SCD=686429; |
Similar Labels: 3098a080-be86-4265-9818-7fc4beab77b7; |
Schizophrenia Quetiapine fumarate tablets are indicated for the treatment of Schizophrenia. The efficacy of quetiapine fumarate tablets in Schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine fumarate tablets for the maintenance treatment of Schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ] . Pediatric use information in patients (13 to 17 years of age) with Schizophrenia is approved for AstraZeneca Pharmaceuticals LP s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. Bipolar Disorder Quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with Bipolar I Disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12 week monotherapy trials in adults, in one 3 week adjunctive trial in adults [see Clinical Studies (14.2) ] . Quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with Bipolar Disorder. Efficacy was established in two 8 week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2) ] . Quetiapine fumarate tablets are indicated for the maintenance treatment of Bipolar I Disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of Bipolar Disorder has not been systematically evaluated in controlled clinical trials [see Clincial Studies (14.2) ] . Pediatric use information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric use information in patients (13 to 17 years of age) with Schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP s marketing exclusivity rights; this drug product is not labeled for such use in those patients. |
Annotated Indication CUIs: C0005586;C0853193;C0036341;C0236788;C0338831; |
RXCUIs for this Label: IN=51272 SCDF=374646; SCD=312744; |
Similar Labels: 758646d8-937d-4a5b-8c68-fd0802f77c28; |
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. |
Annotated Indication CUIs: C0011265;C0002395; |
RXCUIs for this Label: IN=4637 SCDF=384641; SCD=310436;310437;579148; |
Similar Labels: 02b0bed7-96d4-429a-aab0-72c37e0efdaa;0593fa48-8a47-4a0e-a9c6-2ef244470b4e;3bea9961-4d8a-4cf3-8b63-49af2b1fbb5b;4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc;5b72e73f-338d-4c46-81f4-9c0fa4516455;5fd6bd00-6cd6-4e9e-b9e3-757acf1a5766;613509ee-e984-4e22-8056-e01226085f77;63bad97b-3df6-4e8f-b183-95f1e9801c8f;8f07d397-e814-41c8-a7f3-fd666b208cfb;BBDAF2F2-14E6-45C4-B807-5B22955444B0;a074f2c6-fc31-4b04-80da-b905abe839b5;a4632019-f2fa-4a32-9e1f-279f4ba35330;c4572a72-e49a-4c29-b121-a530a6b5fd4f;d1697161-ebe8-42b0-83e7-c9de4412546c;e237f9d6-aba8-4492-b093-1134ed1a75cc;e62efb5a-d2cc-4e11-9e61-10e65ef3d897;ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc;fa3cb01f-85bf-5cc8-7cf3-650d8729078c; |
Haloperidol Decanoate Injection is indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy. |
Annotated Indication CUIs: C0036341; |
RXCUIs for this Label: IN=5093 SCDF=372375; SCD=859867;859871; |
Similar Labels: 5632ada4-05bd-4638-a27a-81d37a66a084;5DE0E919-ACB3-642D-E9E1-8BF08E6DBA79;9f0f42a8-5f7c-4be7-93ef-3ec225502cc6;af0159a8-dff5-449a-aa2b-a0c430081e21;ca9896e0-fb2e-46a4-8700-20d144c14764;f539c374-b61e-4d9b-a0eb-f1a68545ee8c; |
For use as adjunctive therapy in the treatment of peptic ulcer. |
Annotated Indication CUIs: C0030920; |
RXCUIs for this Label: IN=4955 SCDF=372340; SCD=197738;197739; |
Similar Labels: 06bb6f89-4694-4aaa-8bff-f7f3c81d3add;1f266d77-4f9e-44c9-a000-2f8fea3ac80b;493171ca-718d-4c54-b15f-ca33488b80e7;4ec4e4e4-ce23-463b-9296-bff35b005632;725529e8-9c4b-4108-690a-e4f391439736;9690ebaf-be1b-4968-a578-28bd5372f022;a8fbd1e6-8722-42c0-9bb3-7876d1ca2cfd;a9fe52b4-9290-4e26-a142-1506572bc217;b5650ad5-471d-4639-b8da-bdb3d990c627; |
BACTROBAN CREAM is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible strains of S. aureus and pyogenes . |
Annotated Indication CUIs: C0037284; |
RXCUIs for this Label: IN=42372 SCDF=377768; SCD=311877; |
Similar Labels: 76bdab9d-9153-4db6-9b9a-ff376374a8ea;87734c71-a574-465d-b941-f993f9ae8b2b;9257f9cd-abaf-4bb2-d9ac-4bc8f65ae558;cad9604c-7a0d-4716-98e6-235c746a19e5; |
RECTIV (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. |
Annotated Indication CUIs: C0349071;C0278139;C0278140; |
RXCUIs for this Label: IN=4917 SCDF=393438; SCD=1114466; |
Similar Labels: af05dde8-1c06-4cd5-bcd0-8e318874536a; |
CHANTIX is indicated for use as an aid to smoking cessation treatment. |
Annotated Indication CUIs: |
RXCUIs for this Label: IN=591622 SCDF=636670; SCD=636671;636676; |
Similar Labels: 0c4ef9ad-ac23-4f48-8eb8-f5931333deaf;27c6abf0-6551-4333-980d-309b9c1eeba3;3e689dae-5058-4556-be14-df50e2803208;826c77fa-d8b2-48df-8028-720b15912d92;b1b95503-1c7a-44e8-b5e0-d50b61db99d5;f0ff4f27-5185-4881-a749-c6b7a0ca5696;f990eca6-fe6f-4423-a118-4b7b970995a1; |
In patients without structural heart disease, TAMBOCOR is indicated for the prevention of paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms paroxysmal atrial fibrillation flutter (PAF) associated with disabling symptoms TAMBOCOR is also indicated for the prevention of documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life threatening. Use of TAMBOCOR for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of TAMBOCOR is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of TAMBOCOR, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. TAMBOCOR should not be used in patients with recent myocardial infarction. (See Boxed Warnings. ) Use of TAMBOCOR in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed Warnings. ) As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of TAMBOCOR favorably affects survival or the incidence of sudden death. |
Annotated Indication CUIs: C0004239;C0039232;C0340477;C0039240;C0750197;C0085612; |
RXCUIs for this Label: IN=4441 SCDF=498897; SCD=886662;886666;886671; |
Similar Labels: 23f74d33-9e7c-493d-b4aa-ed99ebc361a9;4f6b78d4-8ac8-464b-bb78-ee70cbc97898;89105dbf-1085-4c81-ab19-49c7b5966e7d;b764c8b8-7e23-4016-830f-68312d84f3d3;d3bcb22c-42af-433d-bda4-9add2f3092de;d462d58e-fc3c-4c92-a210-e135eb1f4b77;da585354-87e0-4f8c-90e9-3cbc3496a27a;fa68b35e-9f50-408b-9e70-e84cecf3fd6e;fa83c465-62f5-4ba7-b252-8248cbbefb22; |
APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older. |
Annotated Indication CUIs: C0009324; |
RXCUIs for this Label: IN=52582 SCDF=372783; SCD=825130; |
Similar Labels: 7951139c-b271-45a4-b523-34b23800917b;d5d05b1f-9f45-4f66-9f75-3c67934105de; |
BACTROBAN NASAL is indicated for the eradication of nasal colonization with methicillin resistant aureus in adult patients and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of methicillin resistant aureus infection during institutional outbreaks of infections with this pathogen. NOTE
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Annotated Indication CUIs: C0343401; |
RXCUIs for this Label: IN=42372 SCDF=372971; SCD=311878; |
Similar Labels: 8f44a933-1629-4e65-16a6-9ad421329aa6; |
Mesalamine rectal suspension is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis. |
Annotated Indication CUIs: C0033246;C0033252;C0009324; |
RXCUIs for this Label: IN=52582 SCDF=372785; SCD=238151; |
Similar Labels: 34a30bb0-143b-4624-a8ee-f88c2aefa470;743ada1c-0f04-43ea-be7d-1560164e6f6e;a4ddf68d-1502-4242-89aa-c96436bdcbf6;a666d21d-da21-498d-aea2-055326cafd70;d50f2c37-5675-49f3-bdd4-3b16d333ed40;dfeede98-5520-4fd1-be02-4971453f9e24;eb5bcaab-0f86-4817-9373-0a5e5e1982d2; |
PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis. |
Annotated Indication CUIs: C0009324; |
RXCUIs for this Label: IN=52582 SCDF=372783; SCD=476362; |
Similar Labels: 24998e63-f01e-4a07-be5b-203aadd46941;2c076918-09c0-49bd-bb11-db1e011d597c;6e71e169-bc37-4a1f-bb7d-05bb55345742;70047724-e16b-4ef7-be24-06e651d004d2;70adfac7-f8b7-405c-86aa-b1f30343d38b;805af56e-c180-47af-b9ab-ae25f61736c2;83864c82-9114-4523-bab8-2b47beb88d4e;9444ca88-e119-4027-a8bf-9f8eef7453a2;95de7015-932f-48d4-8734-5906aaee697e;ac724f97-5941-47c1-bcc9-eb5e64be815a;d31a6e7d-31b1-474e-bc7b-821b08115109;d91179bf-48ce-423c-822d-cd06b60caabe;e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606; |
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema Furosemide is indicated in adults and pediatric patients for the treatment of Edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical. |
Annotated Indication CUIs: C0027726;C0022658;C0023890;C0018802;C0013604;C0155919; |
RXCUIs for this Label: IN=4603 SCDF=727573; SCD=899155; |
Similar Labels: 18823BA7-C4C1-4944-9AF5-41D7015F9B53;19152554-70b0-42fb-a3d5-65ceb00e60e3;27fbf6d5-2853-4f26-bf50-9eac8bb82785;2d6a6ff9-3f12-4a6e-bba3-3f85fd54ffac;39fd32f2-6bb7-4a65-d298-e48d26bc80c7;3ec788b9-b851-4022-a3ef-8ec72bc3d258;6040a2ec-3385-44dd-9f8e-f87ad6474be7;869c9eeb-baae-4189-aa5e-0b4e1ee172d2;8e0bac29-5a8b-4d4e-93b3-2e21eb3b0650;CC6E8707-2E6B-4CB8-BF93-117A0AE2559D;a9bc9926-229c-4563-803c-df8f9e13717b;d71487aa-c181-4549-a16a-61551490dec0;e1badec1-77bd-481a-a93c-3150eaeee814; |
Monotherapy and Combination Therapy JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies (14) .] Important Limitations of Use JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. [See Warnings and Precautions (5.1) .] |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=593411 SCDF=665032; SCD=665033; |
Similar Labels: 9f4e2f54-274a-4ecd-9f42-c16437018fdb;aaadccea-4842-493b-a0bd-0ee7645fc250;f85a48d0-0407-4c50-b0fa-7673a160bf01; |
Carefully consider the potential benefits and risks of indomethacin extended release capsules and other treatment options before deciding to use indomethacin extended release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin extended release capsules have been found effective in active stages of the following Moderate to severe rheumatoid arthritis including acute flares of chronic disease. Moderate to severe ankylosing spondylitis. Moderate to severe osteoarthritis. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended release capsules is not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects. The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS, Drug Interactions ). |
Annotated Indication CUIs: C0038013;C0006444;C0029408;C0003873;C0039503; |
RXCUIs for this Label: IN=5781 SCDF=370689; SCD=310992; |
Similar Labels: 29a6b41c-accb-4b12-92d1-cda19c2148a5;3125cb9f-d00c-47e7-9927-fbe38cadb48b;3ea8f628-53f5-41f7-aad3-10ab7d11fd3a;570faaad-3e3e-4b89-9f9a-37c90c20a5d9;5a65b650-ea9b-4d0d-b62f-5971df1e62b4;5e211b18-8cdc-42ab-8756-4ce2dd94925c;c7eb8830-21c0-6e63-3e3a-c13de600faee;d9344dbc-57a8-4fca-bb26-f36a12bf17d4;dbad7e61-2347-43b1-a422-9183e41c10ea;dc80228c-acae-44dc-9762-19bd1669bf45; |
Depression For the relief of symptoms of Depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis May be useful as temporary adjunctive therapy in reducing Enuresis in children aged 6 years and older, after possible organic causes have been excludedby appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration. |
Annotated Indication CUIs: C0011570;C0011573;C0270327; |
RXCUIs for this Label: IN=5691 SCDF=370679; SCD=835564;835568;835593; |
Similar Labels: 01e33e76-02a7-48ca-b3d0-3ba5587566bd;1827a5aa-733a-49d9-89d9-48ea0367b230;2f7d5e7f-79aa-4f3a-b9a6-758d9f3ce74d;35a07f5f-44ca-4e9d-8f18-717a1a6bd59b;55311747-710c-43c4-821d-76323ff2520e;5c96ba0b-a846-4d13-831b-aa2b74e81021;627e6f8b-6056-42de-a279-98cc045bec96;7d52c40c-bbcb-4698-9879-d40136301d31;8c31101d-35cb-36b0-098a-de3c501060b9;a6fe8e00-a1ee-4dbb-bac7-46ac2af9aee9;eeef21dd-2f8c-469c-ad72-36b68dc8e582; |
Nitroglycerin Injection is indicated for treatment of peri operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and b blockers; and for induction of intraoperative hypotension. |
Annotated Indication CUIs: C0155626;C0002962;C0018802;C0020538;C0020649; |
RXCUIs for this Label: IN=4917 SCDF=377109; SCD=237205; |
Similar Labels: 457a026c-ebce-4701-9deb-2d7652759a99;7ea5a071-6f92-4a8a-8e3f-72b74fb2810a;8c52cdf6-87be-4719-b105-f08be096d462;E4A44835-5307-4519-06B6-3E2DCFA61C62;ab0ae3a1-8c43-40c6-2682-5089ee1c0229; |
Isoniazid is recommended for all forms of tuberculos in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant antituberculosis medications to prevent the emergence of drug resistance. Single drug treatment of active tuberculos with isoniazid, or any other medication, is inadequate therapy. Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis) Persons with human immunodeficiency virus (HIV) infection ( 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. Close contacts of persons with newly diagnosed infectious tuberculosis ( 5 mm). In addition, tuberculin negative (less than 5mm) children and adolescents who have been close contacts of in fectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (> 5 mm), therapy should be continued. Recent converters, as indicated by a tuberculin skin test ( 10 mm increase within a 2 year period for those less than 35 years old; 15 mm increase for those 35 years of age). All infants and children younger than 4 years of age with a > 10 mm skin test are included in this category. Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis ( 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Intravenous drug users known to be HIV seronegative (> 10 mm). Persons with the following medical conditions that have been reported to increase the risk of tuberculosis ( 10 mm) silicosis; diabetes mellitus; prolonged therapy with adrenocorti costeroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin s disease; end stage renal disease; clinical situations associated with substantial rapid weight loss or chronic under nutrition (including intestinal bypass surgery for obesity, the postgastrectomy state (with or without weight loss), chronic peptic ulcer disease, chronic malabsorption syndromes, and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high incidence groups
Finally, persons under the age of 35 who a) have none of the above risk factors (1 6); b) belong to none of the high incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactors over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (1 6) and on an individual basis insituations where there is likelihood of serious consequences to contacts who may become infected. |
Annotated Indication CUIs: C0019693;C0151332;C0037116;C0041296; |
RXCUIs for this Label: IN=6038 SCDF=370716; SCD=197832; |
Similar Labels: 1247f0c8-25be-49b0-96e1-22b1cf50dc00;1553312b-ed76-421c-a055-2579bdcf366c;42602989-2a6d-4df6-ac41-780c1aa724ae;43cc6759-3dc6-4a54-a2a1-5afa8ebd76c3;45df9851-27b4-4cce-aed1-c15314876fc1;5aa596d6-2a56-4cd3-8318-3ca54711be13;5ab01773-d1e4-4b87-884a-9e5b3f13bdcb;60a6b514-fa7f-4bc7-85b0-e5a14fa56b59;7367f8da-1212-4f9e-b854-198dd92bf411;77795c31-1cdf-4a20-b4a1-cd15f5b310f1;78E738D9-9C13-4FBD-BFFA-77B003CDADAC;9499f1cf-2f46-4047-8b71-90aee7dee854;c42a2926-8542-49aa-b61b-19a19a31bcb4;da8f086b-00c6-45a9-9694-16654c11fb12;db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2;e43d77c2-f7e8-4d84-9425-37adb38410f0;ec0df56a-7746-45f2-88dc-a975cf48abc9; |
CUVPOSA is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g. cerebral palsy). |
Annotated Indication CUIs: C0007789;C0013132; |
RXCUIs for this Label: IN=4955 SCDF=999960; SCD=999961; |
Similar Labels: e4c2273a-b35a-4e75-9758-970b04d01a87; |
Asacol HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established. |
Annotated Indication CUIs: C0009324; |
RXCUIs for this Label: IN=52582 SCDF=372784; SCD=833234; |
Similar Labels: 03a3bff5-e652-4771-9bf7-3b6850423cc5;e9e91ea6-a701-42f0-8770-fb99044c14f0; |
For the short term reduction of intraocular pressure. May be used prior to and after intraocular surgery. May be used to interrupt an acute attack of glaucoma. |
Annotated Indication CUIs: C0017601;C0595921; |
RXCUIs for this Label: IN=6057 SCDF=370719; SCD=311190; |
Similar Labels: f305b18b-8506-4414-87a1-10aa3b76a691; |
Major indications for griseofulvin are Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringworm of the nails) Tinea cruris (ringworm of the thigh) Tinea barbae (barber's itch) Griseofulvin inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as Trichophyton rubrum Trichophyton tonsurans Trichophyton mentagrophytes Trichophyton interdigitalis Trichophyton verrucosum Trichophyton sulphureum Trichophyton schoenleini Microsporum audouini Microsporum canis Microsporum gypseum Epidermophyton floccosum Trichophyton megnini Trichophyton gallinae Trichophyton crateriform Note Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical antifungal agents alone. It is not effective in Bacterial infections Candidiasis (Moniliasis) Histoplasmosis Actinomycosis Sporotrichosis Chromoblastomycosis Coccidioidomycosis North American Blastomycosis Cryptococcosis (Torulosis) Tinea versicolor Nocardiosis |
Annotated Indication CUIs: C2349994;C0040250;C0040252;C1384589;C0040259;C0040261;C0040247; |
RXCUIs for this Label: IN=5021 SCDF=372354; SCD=239238; |
Similar Labels: 4bb379b4-fdbd-49db-9f79-18583a7cac57;82f52d21-eacd-4edf-8ad5-a8ef090ffa2a;8782397b-92e9-4b14-b194-a11fc2294abc;af318d5d-cc39-4a63-a590-b87c50f2694f;b394ee74-53e5-493a-8ed9-95d3e8a10e88; |
Schizophrenia Quetiapine fumarate tablet is indicated for the treatment of Schizophrenia. The efficacy of quetiapine fumarate tablets in Schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine fumarate tablets for the maintenance treatment of Schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies ( 14.1 )]. Pediatric use information in patients (13 to 17 years of age) with Schizophrenia is approved for AstraZeneca Pharmaceuticals LP s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. Bipolar Disorder Quetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with Bipolar I Disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12 week monotherapy trials in adults, in one 3 week adjunctive trial in adults. [ see Clinical Studies ( 14.2 )]. Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with Bipolar Disorder. Efficacy was established in two 8 week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies ( 14.2 )]. Pediatric use information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric use information in patients (13 to 17 years of age) with Schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP s marketing exclusivity rights; this drug product is not labeled for such use in those patients. |
Annotated Indication CUIs: C0005586;C0853193;C0036341;C0236788;C0338831; |
RXCUIs for this Label: IN=51272 SCDF=374646; SCD=312743;312744;312745;317174;616483;616487; |
Similar Labels: 03325ca1-4f51-41a1-92f3-ff7f96e01cc8;0584dda8-bc3c-48fe-1a90-79608f78e8a0;0f131f23-80dd-4a42-893a-b7d86cd0e037;18e83b0c-1ab5-479e-b269-ec56136aa7b9;1d2a0b16-f272-4974-a8a0-9b8456851298;235f367b-544a-4523-a7bf-a9e2b3aa6fa0;26d92d06-44c5-51ac-27f2-cb1376f6bb68;271e9fb7-3c70-43fc-8279-5adf189f3c22;276e53bf-d3c0-4457-a76e-ee39c1cd2a3d;2d77412a-e084-4406-ac33-d882aece9354;39f4fcea-a586-4c79-a47e-d38c10601fd7;3dc79540-2f24-4920-99cd-ef6482f68eb2;3ea59594-8a2b-4b64-9aa8-1d53d9027bb0;47dc96cb-e586-44dd-a002-1b1d1bf48d3d;5e21f8fc-b32c-4100-a664-15737bdeb32c;6eeef664-ace1-47b3-9193-06ae7eb8e459;7d9d8a97-66ec-40fc-a160-d282c8205e7a;854148e7-53c2-c4c3-a5b1-2397a0b06be4;85522c25-1d1c-477c-8aa7-895ec3dfc3dc;8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6;94dfc588-1fd9-4435-93ec-c6dd4700aef5;a480fe5d-68e0-471c-85cf-a9824bd7a0ae;a951cd63-d329-47c9-965a-582fa73a07c6;cf377de3-1bfa-41ef-8ce8-4a78589dc398;e6e25ef9-2671-489e-8eca-58bedb4f59ab;fc01bdbd-9958-4a87-b59f-962a1f697740;ffe52b98-9872-48c1-90fd-8fcd37c3432f; |
Vasospastic Angina Nifedipine extended release tablets are indicated for the management of Vasospastic Angina confirmed by any of the following criteria 1) classical pattern of Angina at rest accompanied by ST segment elevation, 2) Angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of Vasospastic Angina, provided that the above criteria are satisfied. Nifedipine extended release may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when Angina is refractory to nitrates and or adequate doses of beta blockers. Chronic Stable Angina (Classical Effort Associated Angina) Nifedipine extended release tablets are indicated for the management of Chronic Stable Angina (effort associated Angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and or organic nitrates or who cannot tolerate those agents. In Chronic Stable Angina (effort associated Angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing Angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long term safety in these patients is incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta blocking agents may be beneficial in patients with Chronic Stable Angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS .) Hypertension Nifedipine extended release tablets are indicated for the treatment of Hypertension. They may be used alone or in combination with other antihypertensive agents. |
Annotated Indication CUIs: C0002962;C0699826;C0020538;C0002963; |
RXCUIs for this Label: IN=7417 SCDF=373070; SCD=198034;198035;198036; |
Similar Labels: 03BE089C-07E5-4F94-BFCC-C6101B311785;1f27bd46-5dde-4b2e-88c0-b450f4b94b84;24fa8535-ac4b-46d8-a752-2a7a1c578645;331db003-cc8e-4509-9415-20e48c5cc5b2;3dc7ea33-2b6f-4835-92e2-87a5ca77502b;43062486-bbac-47e4-bae1-16924338c8d8;445fbfa9-ef9a-42d3-a7d5-5a48f8b0af21;453ac443-4fd4-4b5c-b7b4-06d34dc38e0d;45eaef3e-10f2-4588-ab6d-9a9c8dbcbd80;4b05e996-c8c3-4d78-9e51-38e1056c0d24;4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16;5a9b3e3a-fb7a-4cda-892f-c7232c73323c;60b85eab-17ad-4482-87d6-ca9720ca06e0;62069120-e894-42fd-8927-f1d74e449ca6;8818fc86-56a3-44d3-8347-8ef48e71ad84;8ebcb33c-f43b-4b36-9f94-9774b2a59e06;a22e8171-7f26-49b2-b719-8641ba036fc2;b10b3eaf-c28d-4d09-93e0-64c3d4090c78;b11026f8-dea0-49ac-8725-0ef7dc27923f;d1a78ff2-7672-3e69-00ef-63d203c80484;ebcf7ace-2b17-41da-93de-7f9bc1b9d10f;f4eeb69a-be32-4802-979f-6521d00861b4; |
Schizophrenia SEROQUEL XR is indicated for the treatment of Schizophrenia. The efficacy of SEROQUEL XR in Schizophrenia was established in one 6 week and one maintenance trial in adults with Schizophrenia as well by extrapolation from three 6 week trials in adults with Schizophrenia treated with SEROQUEL [ see Clinical Studies (14.1)]. Bipolar Disorder SEROQUEL XR is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of SEROQUEL XR in manic or mixed episodes of bipolar I disorder was established in one 3 week trial in adults with manic or mixed episodes associated with bipolar I disorder as well by extrapolation from two 12 week monotherapy and one 3 week adjunctive trial in adults with manic episodes associated with bipolar I disorder treated with SEROQUEL [ see Clinical Studies (14.2)]. SEROQUEL XR is indicated for the acute treatment of depressive episodes associated with Bipolar Disorder. The efficacy of SEROQUEL XR was established in one 8 week trial in adults with bipolar I or II disorder as well as extrapolation from two 8 week trials in adults with bipolar I or II disorder treated with SEROQUEL [ see Clinical Studies (14.2)]. SEROQUEL XR is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was extrapolated from two maintenance trials in adults with bipolar I disorder treated with SEROQUEL. The effectiveness of monotherapy for the maintenance treatment of Bipolar Disorder has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.2)]. Adjunctive Treatment of Major Depressive Disorder (MDD) SEROQUEL XR is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of SEROQUEL XR as adjunctive therapy to antidepressants in MDD was established in two 6 week trials in adults with MDD who had an inadequate response to antidepressant treatment [ see Clinical Studies (14.3)]. |
Annotated Indication CUIs: C0005586;C1269683;C0036341;C0853193;C0005586;C0012634;C0338831;C0349208;C0338831; |
RXCUIs for this Label: IN=51272 SCDF=721790; SCD=853201; |
Similar Labels: 2a74e8a0-b2fd-4d7f-8bf8-72148b1d3ae7;473a3ac4-67f4-4782-baa9-7f9bdd8761f4; |
BACTROBAN OINTMENT is indicated for the topical treatment of impetigo due to aureus and pyogenes . |
Annotated Indication CUIs: C0021099; |
RXCUIs for this Label: IN=42372 SCDF=372972; SCD=106346; |
Similar Labels: 2289900b-889b-4536-9ed0-3bddb20c9387;2d97832e-c6c7-4a06-b83a-f8369c04f51e;323bcad0-1e11-4946-a151-1a33557f0bfb;3240802f-358d-48bb-9761-64f19e76e931;6a0b39c0-c207-4efc-ac2c-07506ad796df;6dd5868f-0bc2-48c8-238b-e857f5bd812f;900bb675-2f03-47e3-854e-257ec4831332;90cfa2dc-3904-4bd3-b951-dcdb141883bf;a543797a-2c1c-4ea3-bd6c-227a784f92d9;a76947bd-0430-4d79-b4c1-9d1746bc7f84;ae3defca-06d5-49ac-8a27-be5c4e9304d1;c36cd006-08ba-4b3e-b012-4f31c10bd001;c624575e-558c-4cfd-b1e0-c262ed11cff9;dc6c7600-454b-449f-af1c-ff1a8e1b8109;e2ddaea4-d914-4bc7-8913-351e7bf2e2f7;e9b61f01-3c67-42a4-a62b-10f1d1343190;f8ede7ba-fb90-4b3b-8f40-0914ae2e5a8c;ff7428fb-9ce9-4743-b58c-01a05424a57a; |
Allopurinol Sodium for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. |
Annotated Indication CUIs: C0023418;C0024299;C0027651; |
RXCUIs for this Label: IN=519 SCDF=377072; SCD=252931; |
Similar Labels: 10cc918f-aa44-415b-932d-2404695ac449;9bd7a91b-f313-4af3-8714-1102ce8f0aca; |
Haloperidol Injection is indicated for use in the treatment of schizophrenia. Haloperidol Injection is indicated for the control of tics and vocal utterances of Tourette s Disorder. |
Annotated Indication CUIs: C0040188;C0040517;C0036341; |
RXCUIs for this Label: IN=5093 SCDF=372375; SCD=204416; |
Similar Labels: 20B4968E-F869-6365-CAD2-E595832EBE4B;4863db55-cf54-4ec3-96c7-e534a3aa8eeb;c72c2366-7b40-4cd9-845d-4b3983e6141a;e52d40f2-b658-4bc6-8a0c-74a340b762d8; |
Nitroglycerin is indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. |
Annotated Indication CUIs: C0002962; |
RXCUIs for this Label: IN=4917 SCDF=373106; SCD=198039; |
Similar Labels: 041f127e-5166-4484-bc1a-0a373d1187ae;11cb2671-d3d5-425f-8509-f973b6cac876;1dfb2a25-abbd-4fe2-9531-8c76a7b2efa6;33574801-581a-4028-befd-8e0cc8b6a892;43a04d8f-9dc1-4760-98fc-8f976ddc8a4b;78fd9e96-6bfc-4c36-b1da-3a63473aade9;79ba021e-183c-4b4d-822e-4ff5ef54ca61;85b8863e-b8e0-46f4-94a4-7c8e2c66da3f;942008d0-dd1a-48cd-8736-80872a04e0e0;9bec8131-d420-41ea-809c-6607bf5351ea;F9EB07A2-5EBC-40EA-9890-1A0B03E859FF;a1bbfe52-3519-47ca-908b-cf6008d61b1b;b32d82ee-7727-4501-a858-a8304135b11b;dcb552c1-310a-48af-81ad-a74530531dee;de06a4da-ea70-441e-bba2-e40eb51a8c3a; |
Acute Coronary Syndrome Effient is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with Acute Coronary Syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows
It is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation. In the clinical trial that established the efficacy of Effient, Effient and the control drug were not administered to UA NSTEMI patients until coronary anatomy was established. For the small fraction of patients that required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial [see Warnings and Precautions ( 5.2 )] . Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for CABG is considered unlikely. The advantages of earlier treatment with Effient must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG. |
Annotated Indication CUIs: C0948089;C0027051;C0038454;C0040053;C0002965; |
RXCUIs for this Label: IN=613391 SCDF=855811; SCD=855812; |
Similar Labels: 5fe9c118-c44b-48d7-a142-9668ae3df0c6;cb684ad9-0b72-406f-8a07-a419254ccd36; |
INDOCIN I.V. is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x ray. |
Annotated Indication CUIs: C0013274; |
RXCUIs for this Label: IN=5781 SCDF=372469; SCD=346508; |
Similar Labels: 03c71de3-8d3c-407e-a840-3845a7622dd8;0581fd65-63f9-4705-adbd-602fe7b55874;ec482425-358c-4500-8f5d-79c1379c1fa8; |
Hydroxychloroquine sulfate is indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of falciparum . It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. |
Annotated Indication CUIs: C0024138;C0024138;C0003873;C0024537; |
RXCUIs for this Label: IN=5521 SCDF=370656; SCD=979092; |
Similar Labels: 16ea7eee-51c9-4305-9808-358e3ace31bd;1aa44bff-9a62-48b4-a520-98d7d524e3a9;22d4d993-b86d-478e-ac6d-7bcd217e9906;3279d780-0940-f462-9709-83c77f8ae241;6971241c-8323-456e-91a4-a404a9e100de;805a1acd-2e0d-48f1-af6b-0e5d8e06c228;a2d7be5a-98ee-4292-8715-46573dbe1c5b;adf36d25-d86e-4d2d-b90c-e29f1394667d;d5a1c868-b92f-4386-b8f9-8719dd785954;ff0c9d83-6d86-4d22-939b-a838bffbcfd0; |
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies ( 14 ) and Dosage and Administration ( 2.1 ) ]. The efficacy of PRISTIQ has been established in four 8 week, placebo controlled studies of outpatients who met DSM IV criteria for major depressive disorder. A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms depressed mood, loss of interest in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. |
Annotated Indication CUIs: C1269683; |
RXCUIs for this Label: IN=734064 SCDF=790263; SCD=790264; |
Similar Labels: 0f43610c-f290-46ea-d186-4f998ed99fce;2388423e-6f29-4da6-a34d-032a1e503488;4d5d349b-94a2-45a6-a33b-777ee8cfb8b0;a9ff32c4-3bcf-4e51-ae8c-81ff0191ec35;d52d4043-9795-41d0-91f1-d558fe18d680; |
Nystatin Tablets are intended for the treatment of non esophageal mucus membrane gastrointestinal candidiasis. |
Annotated Indication CUIs: C0343886; |
RXCUIs for this Label: IN=7597 SCDF=373137; SCD=312059; |
Similar Labels: b2053672-3a1b-452d-9146-f4d795d82785;b70731df-fead-4f40-941e-7889a9c5d800;e87b8480-987d-4f82-87bf-cf831d6984a1;f03b294d-10cd-4bba-92c8-42ae9b110cd0; |
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Annotated Indication CUIs: C0008350; |
RXCUIs for this Label: IN=62427 SCDF=618512; SCD=858747; |
Similar Labels: 05243d8f-9057-46a9-ae50-6e16ba6cd7dc;1fc89d7b-2457-3ce1-6d10-c6dc7ce9f856;2e799e93-b5a0-40f7-95c5-b40d8a948a0d;35e3194c-ba8b-4b0d-96a6-e2c77e98fda4;5861a269-1752-4378-85d3-f1a8b378b66c;63458d86-fdec-4453-a882-63cad907e49c;8a3bc9f1-e7e3-4268-8941-a44d9f2f812b;91847322-f217-f337-81ca-ef02aca4446b;955df8fb-3341-4a1e-bbdd-152d5c06f1d6;a061bb07-a85d-4b08-877f-ce02156f0de7;aeb6c8c8-4dec-4574-8f26-b6b701b04b25;c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7;cc429def-5c5d-45a6-a575-3e41d927e301;d24c32d6-792d-4d24-b915-746d2499a575;d58f4da2-bc59-4bf3-b851-1fdb73b8cccd;dded5871-205a-489c-b2e2-11f7b00b7a53;e47b49ca-bde9-448a-bf61-f943c2aa5b8e;f0497a34-29d0-7e46-bd62-e41e2cc7f713; |
Nystatin Vaginal Inserts, USP are effective for the local treatment of vulvovaginal candidiasis (moniliasis). The diagnosis should be confirmed, prior to therapy, by KOH smears and or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis ) do not respond to nystatin and should be ruled out by appropriate laboratory methods. |
Annotated Indication CUIs: C0006840;C0700345; |
RXCUIs for this Label: IN=7597 SCDF=374602; SCD=724568; |
Similar Labels: 6e952e14-69e5-4c24-8d70-986da0de20b4; |
Prophylaxis of Deep Vein Thrombosis Lovenox is indicated for the prophylaxis of Deep Vein Thrombosis (DVT), which may lead to pulmonary embolism (PE)
Treatment of Acute Deep Vein Thrombosis Lovenox is indicated for
Prophylaxis of Ischemic Complications of Unstable Angina and Non Q Wave Myocardial Infarction Lovenox is indicated for the prophylaxis of ischemic complications of Unstable Angina and non Q wave Myocardial Infarction, when concurrently administered with aspirin. Treatment of Acute ST Segment Elevation Myocardial Infarction Lovenox, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent Myocardial Infarction or death in patients with acute ST segment elevation Myocardial Infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI). |
Annotated Indication CUIs: C0034065;C0149871;C0027051;C0002965; |
RXCUIs for this Label: IN=67108 SCDF=727722; SCD=854228;854235;854238;854241;854248; |
Similar Labels: 20635579-c92d-4f6c-a332-1096d51002f2;3d263380-4f44-4fd8-aa2a-e69702ab258f;3e6bf2b3-9339-4104-bda3-ad86a1949703;5017a927-2a24-4f27-89f9-27c805bf7d59;53fd1302-9e1b-4e04-b06d-1a706547c388;741c994d-5a25-47e6-865a-33d0d4ccce11;afec67a9-ae16-4f48-bc0b-5331835e8aa2;b2a1cfef-4334-458f-b21c-7966f0e1f3bb;bbebb81f-5137-4097-b91f-7ee87bd12bcf;bd794164-0cad-4ca3-9f62-ae9118f6e4a2;d44a0b9c-848f-4d69-bf56-1befd40de766;de0b16a5-e886-482b-a0be-ab6161648134; |
Therapy with lipid altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established. |
Annotated Indication CUIs: C1956346;C0004153;C0242339;C0020473;C0020557;C0027051; |
RXCUIs for this Label: IN=7393 SCDF=205199; SCD=1098134;1098141;1098143; |
Similar Labels: 0dfe662a-f2ac-4f10-9a08-54cbd0c6dec6;0f049ee9-ab85-401c-b1d7-06c98d559055;35433c7b-556c-49a0-bfb5-0d498359925b;414b3d30-cc7f-4f91-b21e-5090b7f5b529;c64d7717-8e8e-4e17-8f00-2b18f496b321;ccc64ee7-f581-493b-b8c2-6147a0db197e;eac1abb4-58bf-4cd0-aa66-a93e116f516c;f9b97613-c62e-40b0-a2aa-a7fde6bd5bc7; |
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity. |
Annotated Indication CUIs: C0006840; |
RXCUIs for this Label: IN=7597 SCDF=373136; SCD=312055; |
Similar Labels: 01c469b3-ec10-452c-8c02-3e7d22e40297;29a5391d-6db4-4226-82ed-4481b3e445c8;29ccf947-91c1-405a-aba6-5889e3c75d70;3651ad5b-436c-4ae9-9ab1-80b6ac8ae0a8;41034d7b-33a1-4d6d-b425-9cfefff8d518;4c25ae58-c424-44c1-85e0-63b99ecd2ecb;4c71071e-6c9f-4059-ba3f-b9c3aa643452;6976788c-b2fa-4bcc-ada0-4ae589ff5634;855277ef-d6ad-4582-a289-c8c739bf675b;8e451863-6c53-4069-bc0f-71224356bfcb;AF99AA0C-D891-4327-B406-4733F8DAC7BA;ac2bbe44-79e5-430d-b1c3-b2a565964c3e;c808de10-d308-4687-8af3-9e428b7fad8c;ceb0fc2d-9039-4961-84b6-ceb2a2649c50;d468395c-0f4c-4503-9a39-ae847524e683;d824bb63-5c1f-4399-8c0b-38a9f8c60761;f7a98d15-ce46-4358-ac6e-d10afa4d34c2; |
Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE
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Annotated Indication CUIs: C0001622;C0020456; |
RXCUIs for this Label: IN=6964 SCDF=374644; SCD=1245262; |
Similar Labels: 542f3fae-8bc8-4f00-9228-e4b66c9ad6a9; |
Midazolam HCl Syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use (see WARNINGS ). MIDAZOLAM HCL SYRUP MUST BE USED AS SPECIFIED IN THE LABEL. Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see CLINICAL PHARMACOLOGY ). |
Annotated Indication CUIs: C0002622; |
RXCUIs for this Label: IN=6960 SCDF=446503; SCD=422410; |
Similar Labels: 0be63f63-6a93-4782-8f9c-d13ca5ae44bd;20b0cdfa-e2ed-4df3-9ea8-00cc05319bfa;9864801b-6c92-45aa-9c0c-b4b49666c31d;A833C24B-6DCA-44D7-A0D6-20012FA1EA77;c03bba19-85d3-4aa7-ac11-e31a690aa27c; |
Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. Opioid dependent patients, including those being treated for Alcohol Dependence, must be opioid free at the time of initial VIVITROL administration. Alcohol Dependence VIVITROL is indicated for the treatment of Alcohol Dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration. Opioid Dependence VIVITROL is indicated for the prevention of relapse to Opioid Dependence, following opioid detoxification. |
Annotated Indication CUIs: C0001973;C0524662; |
RXCUIs for this Label: IN=7243 SCDF=636638; SCD=637213; |
Similar Labels: 74696d65-6973-6275-7461-77696e646f77;cd11c435-b0f0-4bb9-ae78-60f101f3703f; |
PEDI DRI is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use. |
Annotated Indication CUIs: C0037278;C0011630; |
RXCUIs for this Label: IN=7597 SCDF=244416; SCD=646456; |
Similar Labels: 01b44f91-9b68-464a-9693-b5d3e793bf3c;377b0312-abfe-45eb-9e6e-ae348ec83325;4d845b3f-ca26-4c47-b424-b6d783cc10e5;656fc23b-65af-465e-9bcb-67fbbfa9b84e;A6F88015-4CAC-4CB2-9012-92CC5390B5DF;d62d9d90-3ef2-4697-b6d5-bdb892394998;e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f;e5d3d8e4-3a92-4ac0-8918-d3209a30c12b;e630aa3d-11a6-4300-942a-cbdf2d016f77;eaad7bfe-4d18-446d-b6b8-802e267c13f8;fc141ac5-c14e-4abf-8f2f-98b50a0c63a4; |
depo subQ provera 104 is indicated for the prevention of pregnancy in women of child bearing potential. depo subQ provera 104 also is indicated for management of Endometriosis associated pain. In considering use for either indication, the loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and or lactation, in the risk benefit assessment for women who use depo subQ provera 104 long term (see WARNINGS, section 1 ). Contraception Studies In three clinical studies, no pregnancies were detected among 2,042 women using depo subQ provera 104 for up to 1 year. The Pearl Index pregnancy rate in women who were less than 36 years old at baseline, based on cycles in which they used no other contraceptive methods, was 0 pregnancies per 100 women years of use (upper 95% confidence interval = 0.25). Pregnancy rates for various contraceptive methods are typically reported for only the first year of use and are shown in Table 2. Endometriosis Studies The efficacy of depo subQ provera 104 in the reduction of Endometriosis associated pain in women with the signs and symptoms of Endometriosis was demonstrated in two active comparator controlled studies. Each study assessed reduction in Endometriosis associated pain over 6 months of treatment and recurrence of symptoms for 12 months post treatment. Subjects treated with depo subQ provera 104 for 6 months received a 104 mg dose every 3 months (2 injections), while women treated with leuprolide microspheres for 6 months received a dose of 11.25 mg every 3 months (2 injections) or 3.75 mg every month (6 injections). Study 268 was conducted in the U.S. and Canada and enrolled 274 subjects (136 on depo subQ provera 104 and 138 on leuprolide). Study 270 was conducted in South America, Europe and Asia, and enrolled 299 subjects (153 on depo subQ provera 104 and 146 on leuprolide). Reduction in pain was evaluated using a modified Biberoglu and Behrman scale that consisted of three patient reported symptoms (dysmenorrhea, dyspareunia, and pelvic pain not related to menses) and two signs assessed during pelvic examination (pelvic tenderness and induration). For each category, a favorable response was defined as improvement of at least 1 unit (severity was assessed on a scale of 0 to 3) relative to baseline score (Figure 2). Favorable Response = reduction in severity of symptom or sign of 1 point on a scale of 0 to 3, as compared to baseline Additionally, scores from each of the five categories were combined, with the total (composite score) considered a global measurement of overall disease improvement. For subjects with baseline scores for each of the 5 categories, a mean decrease of 4 points relative to baseline was considered a clinically meaningful improvement. Across both studies, for both treatment groups, the mean changes in the composite score met the protocol defined criterion for improvement. In the clinical trials, treatment with depo subQ provera 104 was limited to six months. Data on the persistence of benefit with longer treatment are not available. Subjects recorded daily the occurrence and severity of hot flushes. Of the depo subQ provera 104 users, 28.6% reported experiencing moderate or severe hot flushes at baseline, 36.2% at month 3, and 26.7% at month 6. Of the leuprolide users, 32.8% reported experiencing moderate or severe hot flushes at baseline, 74.2% at month 3, and 68.5% at month 6. Figure |
Annotated Indication CUIs: C0014175;C0030193; |
RXCUIs for this Label: IN=6691 SCDF=727610; SCD=1000156; |
Similar Labels: 390087a6-f3c3-4f0b-a930-79acf412f153; |
Attention Deficit Hyperactivity Disorder Vyvanse is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Vyvanse in the treatment of ADHD was established on the basis of three short term controlled trials in children ages 6 to 12 years, one short term controlled trial in adolescents ages 13 to 17 years, and two short term controlled trials in adults who met DSM IV TR criteria for ADHD, and one maintenance trial in adults [ see CLINICAL STUDIES (14) ] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM IV ) implies the presence of hyperactive impulsive and or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g. in social, academic, or occupational functioning, and be present in two or more settings, e.g. school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least 6 of the following symptoms (or adult equivalent symptoms) must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can"t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM IV characteristics. Need for Comprehensive Treatment Program Vyvanse is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational vocational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician"s assessment of the chronicity and severity of the patient"s symptoms and on the level of functional impairment. |
Annotated Indication CUIs: C1263846; |
RXCUIs for this Label: IN=700810 SCDF=700812; SCD=854830; |
Similar Labels: 704e4378-ca83-445c-8b45-3cfa51c1ecad;a310fc51-2743-4755-8398-fed5402283f6;c9eaca3d-cca7-4627-bb3e-75b1c2aec9d4; |
NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder. In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of NUVIGIL in long term use (greater than 12 weeks) has not been systematically evaluated in placebo controlled trials. The physician who elects to prescribe NUVIGIL for an extended time in patients should periodically re evaluate long term usefulness for the individual patient. |
Annotated Indication CUIs: C0520679;C0917799; |
RXCUIs for this Label: IN=641465 SCDF=724858; SCD=724861;724863; |
Similar Labels: 10f918f7-4782-470e-a50e-35c7c66bfd79;d878aed0-ddbf-8fa1-abf7-d3e480260845;e7bfb636-4b0a-440c-a4d3-d26393a14ac5; |
Norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection. |
Annotated Indication CUIs: C0014175;C0232940;C0042134; |
RXCUIs for this Label: IN=7514 SCDF=373114; SCD=1000405; |
Similar Labels: 64cb920c-36e8-4d62-9d08-3ddf3989d313;69f5bc4b-758d-471b-ad8d-17c94f8e0963;d0a94321-eb60-4aa6-a429-f0156f9f8e01;f73f9807-4af6-4faa-ba9a-656a47a4c5e0; |
Symptomatic Gastroesophageal Reflux Disease METOZOLV ODT is indicated as short term (4 to 12 weeks) therapy for adults with symptomatic, documented Gastroesophageal Reflux Disease (GERD) who fail to respond to conventional therapy. Diabetic Gastroparesis (Diabetic Gastric Stasis) METOZOLV ODT is indicated for the relief of symptoms associated with acute and recurrent Diabetic Gastroparesis (Gastric Stasis) in adults. Important Limitations METOZOLV ODT is indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established. |
Annotated Indication CUIs: C0267176;C0152020;C0017168; |
RXCUIs for this Label: IN=6915 SCDF=608622; SCD=608623;608624; |
Similar Labels: f0892106-399d-4e53-ae8d-8797c50ce7bf; |
MYKROX Tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX TABLETS HAVE NOT BEEN EVALUATED FOR THE TREATMENT OF CONGESTIVE HEART FAILURE OR FLUID RETENTION DUE TO RENAL OR HEPATIC DISEASE AND THE CORRECT DOSAGE FOR THESE CONDITIONS AND OTHER EDEMA STATES HAS NOT BEEN ESTABLISHED. SINCE A SAFE AND EFFECTIVE DIURETIC DOSE HAS NOT BEEN ESTABLISHED, MYKROX TABLETS SHOULD NOT BE USED WHEN DIURESIS IS DESIRED. Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia (see PRECAUTIONS ). Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. MYKROX is not indicated for the treatment of edema in pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=6916 SCDF=372888; SCD=197977; |
Similar Labels: 0b619826-2567-49d7-8972-b6da5e4467df;34868f95-78d0-4089-8cbd-bec1cb730eda;449ebee4-6feb-428b-8cae-9bb0a49d1d3d;6639d111-eb21-4997-b964-f5c61bc088f2;c893c914-6195-45fa-a2bc-4e8b78004737;dffb4544-0e47-40cd-9baa-d622075838cc;e5fe856e-7fd6-47fb-87f7-7c1c621f50a0;f45f5353-38a3-42c6-bffc-96bea8dcf818; |
Methimazole is indicated in the medical treatment of hyperthyroidism. Long term therapy may lead to remission of the Methimazole may be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Methimazole is also used when thyroidectomy is contraindicated or not advisable. |
Annotated Indication CUIs: C0020550; |
RXCUIs for this Label: IN=6835 SCDF=372827; SCD=197941;197942; |
Similar Labels: 036ad971-9946-4950-8530-2a1a90bdcb1d;74238d87-5f82-4a5e-a920-a9fc68115e91;8c3a9aaa-cdde-404b-9af6-5a88ef649aac;9e6b80b8-6780-da50-f18f-30e6fe7b01b9;A3A62C66-BBA9-4A96-B409-90687CA4A76A;DC92F45F-8D27-4dcb-B72D-6B8B04C6F0CE;bfb90441-ebc4-4650-bbaa-28d649572919;f7675cf7-77df-461a-aee4-a6206970431b; |
Symptomatic Gastroesophageal Reflux Metoclopramide tablets are indicated as short term (4 to 12 weeks) therapy for adults with symptomatic, documented Gastroesophageal Reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12 week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic Gastric Stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more. |
Annotated Indication CUIs: C0151970;C0341117;C0267176;C0152020;C0017168;C0003123;C0018834;C0027497;C0042963; |
RXCUIs for this Label: IN=6915 SCDF=372886; SCD=311666;311668; |
Similar Labels: 1c82c808-fc1d-4564-8120-ce2532092514;201e71d6-6a69-4ca8-9eb6-9821f45f8d18;2c7f7c84-da53-4fba-ac29-1c3652dd5b3a;2fc288bd-b176-42d5-945f-7f4ff370a57e;436391ed-1bf9-407b-1854-9796537bdf50;4ab8ddab-8226-4b5a-8774-308ed49d6bc4;55f1ee88-a455-44ba-b51a-2fcefe8eda65;59abd52d-8172-44a3-baa2-fe1fe20f78c0;6cef9808-d867-4908-964b-c57ce500dccc;6e3e5317-14b0-4786-90e7-6ed86eb4d8f5;73f4a334-66d7-4e06-82f1-562bd7cb601a;80fb18a3-824a-4360-947e-63f0a167245b;869349b7-a037-47b5-9da6-e061cefc3ced;8cdd6af4-7124-4ea5-b822-92b8edd3a442;9558e870-aa8b-4646-a701-1e9416c02f11;9daf95f8-f326-4fb0-8a14-022999c9fdeb;a637c1ac-78d1-4d44-9c79-b6da9a8f2fb9;a6e402d9-623d-444d-94f0-21f4977d3d40;a791c769-f859-4b01-a8bf-4f8ccb2ab8c1;acdb3ee0-006e-4799-8732-5488ef72f90e;ad81576a-6a25-438e-b39e-d04d7c4b9595;b73e7993-b5fb-4147-8bbe-eba686a5d051;baacecf3-b371-42c6-bf58-bd4141ddb665;cafb55ed-f2fb-4462-8b5c-c0e34cd83cbc;de55c133-eb08-4a35-91a2-5dc093027397;e15905e0-e0f6-4c8b-ac19-59724d6c4bf0;f08671b6-dc76-450a-8c8c-9d54f9611c00;f32d6e27-5b7b-4b17-af2e-0250447ee560;fae9b5cc-f32f-4e60-91f0-efbb53c1c880;fd13743d-ec41-4782-8068-4a18d4a6eb4e; |
Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide Injection, USP is indicated for the relief of symptoms associated with acute and recurrent diabetic Gastric Stasis. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy. Metoclopramide Injection, USP is indicated for the prophylaxis of Vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting. Metoclopramide Injection, USP is indicated for the prophylaxis of Postoperative Nausea and Vomiting in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation. Metoclopramide Injection, USP may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination. Metoclopramide Injection, USP may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and or small intestine. |
Annotated Indication CUIs: C0267176;C0152020;C0027497;C0520904;C0042963; |
RXCUIs for this Label: IN=6915 SCDF=727618; SCD=727619; |
Similar Labels: 1ecab710-8b7d-4903-80a8-de66562be55a;373ba08b-33ad-49fc-28a7-928e89a65314;5498f6aa-f4c1-49a3-b969-0711077dde81;6f4af312-ad59-412b-ba67-c5e3e91f90a3;7e14591f-0062-4159-b9d3-095b4ad68f00;917494a9-cff1-4ee6-9523-e112120373c5;FFA52DFA-8ADF-4F70-39A7-461757F226E9;a075cffe-6aeb-43f7-9533-de978a962b77;bfbc4b74-509b-4df8-be2b-d665c6a070af;cccf04bd-7463-40b8-a41f-cb1093c358d7;e2857ea0-df36-4d91-a705-a574fa323b2e; |
For the relief of moderate to severe pain For preoperative medication For support of anesthesia For obstetrical analgesia |
Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=6754 SCDF=372764;727616; SCD=861459;861463;861473; |
Similar Labels: 0084d5bc-17d5-4c58-a791-7ab3bb4590b7;53ddfe26-5a7e-4f39-8904-829a03538f63;987a91b8-dd9e-47ce-bd43-f8189a54838e;b31d1308-28c3-43f4-e0a6-2f3ed76b8975;e0e998da-f056-4fce-be8e-ed60cf3b461b; |
DEMEROL is indicated for the relief of moderate to severe pain. |
Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=6754 SCDF=372766; SCD=861455;861467; |
Similar Labels: 15bc51a8-1e24-4d33-9a2f-05a41c29acf0;3187a670-e0de-47b0-9c68-fdf7d2d162d6;6c2b41c3-732c-477f-8790-0eecea43b2da;7c065a08-bd12-4d43-ad9a-13228d99d106;7df4e964-2a34-4f38-4d8b-62bb637323c7;8f9e0a64-cae4-4a56-8a3e-3dec2e705759;9C4F12E5-5E69-44D4-81A5-BD72C375EEF5;AF5B3E8B-D6DC-4664-89A7-F347D1853ACE;c3ad5e7c-56e5-415c-87fe-a22a307e9b60;c550b809-fbea-4070-824d-2aeda4150fb5;cca1bdfb-3e40-4401-a2e2-78403c7237ba;e89f69d8-e3f0-4e83-b512-fa8f67c6feb5;fae5cc34-5917-4445-9516-25f97ffca8db; |
Status Epilepticus Lorazepam Injection is indicated for the treatment of Status Epilepticus. Preanesthetic Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see PRECAUTIONS Information for Patients ). |
Annotated Indication CUIs: C0038220;C0003469; |
RXCUIs for this Label: IN=6470 SCDF=372645; SCD=238100; |
Similar Labels: 095ab8ff-83c5-4906-ae67-b04f4a58b58d;20140b19-846b-425f-b191-670e17809945;37e2cdf0-e4ba-4307-993e-198c7089cabc;4084fa74-9fd2-45ef-9d56-27bfa31d4e46;415672b5-bab8-437c-9ee4-9c729208eda3;4C3BF7CF-A62F-4B92-C5B8-CBFC79CC97E9;5fc0e987-61c9-40c4-b0d5-fcea07c8733e;608a0345-fc9c-4170-4f8d-96dbdd7e566a;AE274B1F-27C3-483B-99F1-9A9249DC2459;a9f7d22e-43fc-46c8-b2a9-a00b0d25d4ac;b5b17cde-a94c-4105-871c-54e7d2bd47e8;ba5527fb-76fc-4ee5-b62e-a141c58c957d;e9b54e42-04cf-4c62-90e1-36f7b31a4e81; |
REVIA is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. REVIA has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. |
Annotated Indication CUIs: C0085281;C0001973; |
RXCUIs for this Label: IN=7243 SCDF=372990; SCD=198011; |
Similar Labels: 06ff2d5a-e62b-4fa4-bbdb-01938535bc65;0d929bf5-2eaa-4679-8334-1ac159b2b55c;0f30f885-d0cd-4fa6-a8e0-142f08a56792;1977a47c-1029-465a-8176-3c9d70c7bbc8;3c7da2bc-e2c1-48f6-8c3f-287119b427e2;49aa3d6d-2270-4615-aafa-b440859ab870;4a63f1e0-b2a3-4355-af61-852ea3521707;81e25c6a-81b6-4cfb-91bf-be20c3ae546b; |
Immunocompetent Adult Patients Herpes labialis (cold sores) Famciclovir tablets are indicated for the treatment of recurrent herpes labialis. Genital herpes Recurrent episodes Famciclovir tablets are indicated for the treatment of recurrent episodes of Genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established. Suppressive therapy Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of Genital herpes. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established. HIV Infected Adult Patients Recurrent orolabial or Genital herpes Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or Genital herpes in HIV infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established. Limitation of Use The efficacy and safety of famciclovir tablets have not been established for
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Annotated Indication CUIs: C0019342;C0019345;C1274321; |
RXCUIs for this Label: IN=68099 SCDF=372137; SCD=198382;199192;199193; |
Similar Labels: 2c44b8d2-3b70-4e8b-af03-2e917178f761;3c6194c0-ba69-4b16-b882-caf736a02348;3cd2e7f1-cbdb-47f6-b37f-830aaaef2482;3f02042f-8f51-4ccf-b608-5dcd75d100fb;405372a1-83bc-4843-b1b2-bd8ff2f83f87;50194d47-2761-4bfd-a35b-9c6a186694a5;5c133dfe-3cb5-426b-ac30-daf814e12c47;9bced3c4-f450-4e21-9baa-ab2efd0ed4bd;9f2714cd-0a45-235c-7490-747a9af67471;a5c46194-3692-cd26-0d85-6371974ccc44;c5617ff1-33a1-4d50-9b1c-e3fc4767f373;e563b079-a892-4505-a4ab-e6c9c8c02a51;fbc08644-e437-456d-9936-bbce99b2bd27;fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343; |
Methimazole is indicated
|
Annotated Indication CUIs: C0020550;C0154143; |
RXCUIs for this Label: IN=6835 SCDF=372827; SCD=197941;197942; |
Similar Labels: 4280e008-bbaf-4cc7-b588-3b4303016067;4d42cebc-5d3e-4b88-883f-5875b83a5515;992ad6dc-663e-44cb-b313-21aeb72ecc9d;a57ff449-e3b7-48b6-9acf-c719a9770e8a;ca8c1028-216d-485a-90df-b54818451bc3; |
Therapy with lipid altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Nicotinic acid, alone or in combination with a bile acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types IIa and IIb) , when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the NCEP treatment guidelines 6 ). Prior to initiating therapy with nicotinic acid, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total cholesterol, HDL cholesterol, and triglycerides. Nicotinic acid is also indicated as adjunctive therapy for the treatment of adult patients with very high serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Such patients typically have serum triglyceride levels over 2000 mg/dL and have elevations of VLDL cholesterol as well as fasting chylomicrons (Type V hyperlipidemia) . Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to develop pancreatitis. Therapy with nicotinic acid may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. Some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of nicotinic acid therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL. Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia 7 . |
Annotated Indication CUIs: C0020481;C0020473;C0004153;C0020557;C0030305; |
RXCUIs for this Label: IN=7393 SCDF=373053; SCD=198024; |
Similar Labels: ce739d68-d89c-437c-90fb-3c0c45140f22; |
Chronic Idiopathic Constipation Amitiza is indicated for the treatment of Chronic Idiopathic Constipation in adults. Irritable Bowel Syndrome with Constipation Amitiza is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS C) in women 18 years old. |
Annotated Indication CUIs: C0267509;C0009806;C0022104; |
RXCUIs for this Label: IN=623033 SCDF=616577; SCD=794639; |
Similar Labels: 222817c2-d4a6-43d0-8cbb-215f19acb198;417aa15d-ac74-4fa8-a312-6e51e82ba70c;ca79dddc-3911-472b-bda7-a23351be09af;d474ac6a-444d-4aa6-9986-24be6fcf811d; |
Medroxyprogesterone acetate tablets are indicated for secondary amenorrhea and for abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate tablets are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving 0.625 mg conjugated estrogen. |
Annotated Indication CUIs: C0014173;C0232940;C0042134; |
RXCUIs for this Label: IN=6691 SCDF=372739; SCD=1000114; |
Similar Labels: 2627eb11-06bf-4a45-9172-094468e3ca07;37275fd0-eb24-40a4-a93f-b818bb98414e;437edd12-2c08-4df4-8cf7-64c47e4779ac;499051ac-ffaf-4db4-be45-a409bd54991f;60cf7eda-3ee3-4f26-96be-ec97e4058735;826f674c-8ef2-400a-bf0b-877320a8cb5d;a586be28-96af-4fed-a13f-9b94fd4c7405;d2c3d585-3b01-448b-a630-3ea9aa34bccb;e5f5c46c-b8b7-4502-9d2b-8f12284d1a63; |
URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis. |
Annotated Indication CUIs: C0008312; |
RXCUIs for this Label: IN=62427 SCDF=618504; SCD=858751; |
Similar Labels: 46a9db4f-b181-4050-bb8b-5adb1a8496ca;89783608-d4fa-4f57-949a-e4a30366ee51;90593214-5e4d-4b91-b308-a82311a3e4f9;aea8eb45-0452-44ad-b562-b5d9a1586c38;e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61;fb79b62a-b450-4d7a-be28-5ee4d174fd58; |
1.1 Major Depressive Disorder Cymbalta is indicated for the treatment of Major Depressive Disorder (MDD). The efficacy of Cymbalta was established in four short term and one maintenance trial in adults [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms depressed mood, loss of interest in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. 1.2 Generalized Anxiety Disorder Cymbalta is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of Cymbalta was established in three short term trials and one maintenance trial in adults [see Clinical Studies ( 14.2 )] . Generalized Anxiety Disorder is defined by the DSM IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and or sleep disturbance. 1.3 Diabetic Peripheral Neuropathic Pain Cymbalta is indicated for the management of Neuropathic Pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies ( 14.3 )] . 1.4 Fibromyalgia Cymbalta is indicated for the management of Fibromyalgia (FM) [see Clinical Studies ( 14.4 )] . |
Annotated Indication CUIs: C0016053;C0270549;C1269683;C0027796;C0740447; |
RXCUIs for this Label: IN=72625 SCDF=540628; SCD=596926;596930;596934; |
Similar Labels: 059d730b-4294-47e1-8399-4cb8c468cee8;12d274cc-77b7-469b-91c6-14105456c135;27b5ffa0-371c-42b0-b430-fc3772a66d69;2b905292-9d96-ae37-cc21-3e3f19920143;2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba;5f2147ee-2dfa-4d92-b414-b7a830c5ecdb;604b9f2f-fee6-48ef-a6c2-289bf98692b1;67927928-c20f-4e12-a327-d26561d7810a;67a3691e-5ab8-43f0-9c59-69ccf2383834;6b3d9ba5-55d3-4240-ba79-97b9f608645b;6fd7131e-7ac4-42f5-8678-316cf909d942;7db112de-473a-4407-bc1c-35d0ab748700;81a06b90-50d3-40c1-98ca-0e344c76b2c4;baaa3a1a-bada-082f-5e77-d9013c6fc109;e2d9c819-ca37-4094-b5f7-6a2f2df1bf84;e4fa801e-c3ea-40ff-9cee-e88f22f74931; |
Spironolactone is indicated in the management of Primary hyperaldosteronism for
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Spironolactone is indicated in pregnancy when Edema is due to pathologic causes just as it is in the absence of pregnancy (however, see PRECAUTIONS Pregnancy ). Dependent Edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with Edema, including generalized edema, in the majority of pregnant women. If this Edema produces discomfort, increased recumbency will often provide relief. In rare instances, this Edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. |
Annotated Indication CUIs: C0001430;C0023890;C0018802;C0013604;C0085580;C0020621;C1384514;C0003962;C0333976;C0342495;C0027726;C0020488; |
RXCUIs for this Label: IN=9997 SCDF=373946; SCD=198223; |
Similar Labels: 01deb112-edf1-4ed6-bc04-672d02ce66ab;0fed2822-3a03-4b64-9857-c682fcd462bc;19e50a28-8087-44c3-811b-b30d3bca5ba4;2d98eab1-6713-4b8c-a17c-f136e9972bce;2efb4720-625f-6616-b6f0-8b13a17c9d7e;322f2b36-ca93-4a57-9413-ef4efbbb3c65;3416d8b8-7692-a6a3-7a8b-28a623b346e0;4542d698-0299-4b6f-91a7-c8127384ca0c;48115c9e-c82f-438d-b178-dce1b73687db;4a8b16c6-08e8-4b93-9a4b-30fc43f332c6;617aef1f-3f2c-4d33-8baf-40995b8f6a24;6ac04cc4-b044-45a3-ac41-a4dfc4969697;7a0bba98-8f39-4020-b2a5-c487278a057a;7c850c17-9a7d-423a-86bd-ac108d1c7932;7d16b436-c76c-4ac8-b36a-149a14faecab;7e1a8152-941a-4aa4-bcb0-83c04905678f;81ce9360-f956-4d65-b086-4827f106d27e;90668e5a-0c0d-4941-94cf-8b2fba410ed7;922b2c82-052a-416c-984f-0dd66f2c61c4;a98fca05-7896-411b-8a80-1588be1fac00;ad43304a-3b3a-4708-92c7-56aa393ee906;beaf74db-4159-3b59-ef99-575c3ac99aa1;c22b0765-1777-4001-836a-2684daf2a35b;c23b6b9b-aec3-48a8-a518-76e4097f6479;e574545f-bb08-4654-98b3-bdb6666004a8;e5bf608e-c6dd-44e8-96aa-ba4660f64de0;e9ce6841-9bf6-42c2-a56d-c8d08bac2d9e;f802ebee-1c21-4254-9e14-5a83ffdb82ba;fb66327e-8261-46ae-b39a-4fa79d520844; |
Propylthiouracil is indicated
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Annotated Indication CUIs: C0020550;C0154143;C0018213; |
RXCUIs for this Label: IN=8794 SCDF=373658; SCD=198175; |
Similar Labels: 103c6393-d5c9-4efd-817c-2d6e5fec1704;120de758-f102-470a-892d-a61b18ff8f71;88765882-d76e-2464-8a8f-e51afb2b4633;a57c49ae-d659-49fa-84e3-cf6d1f9e6f97;b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0;d270ea0a-bbcf-4a87-8299-8cbe03c13958;ff603c99-6620-4945-acdc-c9150b6f77d4; |
1.1 Healing of Erosive Esophagitis KAPIDEX is indicated for healing of all grades of Erosive Esophagitis (EE) for up to 8 weeks. 1.2 Maintenance of Healed Erosive Esophagitis KAPIDEX is indicated to maintain healing of EE for up to 6 months. 1.3 Symptomatic Non Erosive Gastroesophageal Reflux Disease KAPIDEX is indicated for the treatment of heartburn associated with non erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks. |
Annotated Indication CUIs: C0267055;C0017168;C0018834; |
RXCUIs for this Label: IN=816346 SCDF=833203; SCD=833204; |
Similar Labels: 67464901-d29e-4706-b337-e3e27707fdbe;9819f033-3bbe-442e-8e92-45fec77b237d;c83616c9-c222-4e3e-91bd-c7839406bb2a;d62d754e-2310-4912-b022-603ae925710d;fd3c2497-ab34-4e19-a7c8-e599025435c8; |
PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea. |
Annotated Indication CUIs: C0014173;C0232940; |
RXCUIs for this Label: IN=8727 SCDF=373616; SCD=260243;312641; |
Similar Labels: 0224b5a6-25a3-44c9-b94f-90e2e064c164;849e9f62-7414-3c22-9cb1-934f953400fc;cf73c385-5173-4b54-af23-069581c5d560;dc64d6d6-b773-4f6b-b563-d389bf89bbc5; |
IQUIX solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria |
Annotated Indication CUIs: C0010043; |
RXCUIs for this Label: IN=82122 SCDF=376884; SCD=545118; |
Similar Labels: 067ea8ec-99a3-4a0b-9116-4ffd6160b24b;09b3a912-97f9-45ae-a162-9f45c860dc22; |
This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. |
Annotated Indication CUIs: C0002453;C0042134; |
RXCUIs for this Label: IN=8727 SCDF=374412; SCD=312644; |
Similar Labels: 83cfc12e-75d1-4284-bcc3-beadcbd27171;a09a3b76-36f1-4d20-930e-7e3da97e7ebd;a479b395-1e1a-4d2a-8feb-68a15c47225f;b79abe4a-0242-41da-b91b-df723b85f0cc;dbe573fc-32b5-4e99-b18e-e22aa0fb7165; |
Monotherapy and Combination Therapy ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. [See Clinical Studies (14) .] Important Limitations of Use ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. ONGLYZA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using ONGLYZA. [See Warnings and Precautions (5.1) .] |
Annotated Indication CUIs: C0011860; |
RXCUIs for this Label: IN=857974 SCDF=858035; SCD=858036; |
Similar Labels: ba48ac4b-9503-4006-f6e2-3b8a83059c03;d45fc842-2563-4421-86af-a55b3191e19b; |
Extended phenytoin sodium capsules are indicated for the control of generalized tonic clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY ). |
Annotated Indication CUIs: C0494475;C0036572; |
RXCUIs for this Label: IN=8183 SCDF=373435; SCD=855671; |
Similar Labels: 836cd001-99e8-4591-860a-07094ea0de74;b73ab327-ecb9-4d0c-8b89-17890153608e;ca119a89-2394-4d34-8078-cd1fa4e8e2f1; |
For the relief of moderate to moderately severe pain. |
Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=7804 SCDF=373196; SCD=1049615; |
Similar Labels: 6eaff86d-3b90-499e-b46f-316a35f5d811;d25b9c43-7127-4206-aa63-3b5dedfa7849;d46fcd26-a828-4b9f-af88-1f62a7cb9598; |
In the treatment of both Tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Tuberculosis Rifampin is indicated in the treatment of all forms of Tuberculosis. A three drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of Tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. Meningococcal Carriers Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS .) Rifampin should not be used indiscriminately, and therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
Annotated Indication CUIs: C0041296; |
RXCUIs for this Label: IN=9384 SCDF=373781; SCD=198202; |
Similar Labels: 036ab68e-5085-4edc-bd83-784b43d64eab;0609253c-505b-c6d0-241e-90ffdba25ca2;0a99a222-580b-4d80-8aaf-1c74d9a6caab;0c7adf7f-d2c3-4b3a-b81b-dcaae7cc3036;1881d0ef-38d3-4ecc-bd51-d20679b7dc2f;26a2dbca-5090-4f6c-99ed-e11a70bb5af0;363d2275-fca2-4c6d-940c-137e89d9d78c;3cc0bcd2-37d7-4a7b-808b-980d864281af;4cb11585-a53f-4ef6-a52d-8cff3a4fd8eb;540eaf0a-da8d-41ce-b9c5-0c4e0733a179;55816042-946d-4bec-9461-bd998628ff45;78c4d20c-9d9b-4f26-bc11-ff193c6c53ca;85532a0e-24fa-4a4f-9a0e-721502fa7d7e;9498a2f4-6b05-4811-80d7-9acaa9cf59a5;a086ceb6-7796-437f-865d-e25b39bd1a23;b4d41487-b8f3-4f36-9144-f0e67a2ea53a;b58b9f95-6886-40a9-a443-ad95eebebcf0;d7131853-8850-45bd-9227-c4b1916dd28d;eef30745-075c-4430-8271-2c3f353f40a2; |
Sulfasalazine tablets are indicated
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Annotated Indication CUIs: C0009324; |
RXCUIs for this Label: IN=9524 SCDF=373991; SCD=198232; |
Similar Labels: 37e65a87-c68c-40da-bc13-1f5455858fa1;3f915e6f-aa04-4ba6-8553-d443fb177d6d;48fbc535-a33a-45ee-85ff-9d1ec9b31d9c;6e90e3e6-b4ee-42b3-9fdc-33ef333eb79a;ad13d598-7b1b-48d3-a25b-08635b419f99;ddbe69f3-bd55-45f3-a64f-f60226c744c4;ee7129fd-525b-4ed3-b8a6-e4587697f655; |
In patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of
The use of propafenone in patients with chronic atrial fibrillation has not been evaluated. Propafenone should not be used to control ventricular rate during atrial fibrillation. Propafenone hydrochloride tablets are also indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life threatening. Because of the proarrhythmic effects of propafenone, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks. Initiation of propafenone treatment, as with other antiarrhythmics used to treat life threatening ventricular arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular or atrial arrhythmias. |
Annotated Indication CUIs: C0004239;C0030590;C0085612;C0042514; |
RXCUIs for this Label: IN=8754 SCDF=373637; SCD=861424;861427; |
Similar Labels: 352d26ca-9f68-42bd-ad8c-ed647aca7009;36e02614-9346-483e-8beb-711519b80a9d;3b453b16-b050-4dda-8e2f-40924e7f7d1c;578d747f-c023-4d5a-9e9a-d4a970d8f69f;8dd938c8-d37c-4a82-b36d-dd0a2d31c8fa;9017ff99-cf37-43f4-95cc-3477f1940c54;9ad1b5f4-fbb7-46b5-a719-796d85cd4c54;a313c111-e539-47bc-9d57-c3767f74bcca;a7c8f090-c48c-44f7-9973-2cf4b491e35c;d4a552ce-f215-4ec7-b5dd-aee266ba9b08; |
RYTHMOL SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations
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Annotated Indication CUIs: C0004238; |
RXCUIs for this Label: IN=8754 SCDF=406230; SCD=861156;861164;861171; |
Similar Labels: 01ede254-7d2a-4a6f-a253-01d77770022e;0e9d1433-a55e-4907-bb38-abac47c7d3c7;8bb1bc4a-a019-49c8-af81-be899822428f; |
Oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. |
Annotated Indication CUIs: C0278140;C0184567; |
RXCUIs for this Label: IN=7804 SCDF=373195; SCD=1049696; |
Similar Labels: 061cf52b-4432-422d-a97b-c3e1f8c4bab6; |
PredniSONE Tablets are indicated in the following conditions
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Annotated Indication CUIs: C0085669;C0035440;C0009766;C0038013;C0032290;C0011615;C0005138;C0004096;C0008513;C0009326;C0001627;C0011616;C0037274;C0013604;C0014130;C0014488;C0877221;C0011606;C0017178;C0018939;C0019364;C0020437;C0043117;C0022081;C0022568;C0023418;C0242459;C0026948;C0029134;C0030807;C0001403;C0271738;C0003872;C0010346;C0035204;C0035435;C0003873;C0154301;C0036830;C0029077;C0039103;C0024141;C0040896;C0041318;C0009324;C0002871;C0443146;C0008526;C0011608;C0011633;C0014742;C0003868;C0002878;C0020517;C0178416;C0022073;C0553662;C0024299;C0024799;C0027726;C0029408;C0035457;C0085655;C0042167;C0033687;C0033860;C0041327;C0036202;C0036508;C1290159;C0039520;C0040147; |
RXCUIs for this Label: IN=8640 SCDF=373585; SCD=198145;312617; |
Similar Labels: 0a9ce62e-2a61-4dc3-a921-0da9ffbe1c76;0dfb483e-e93b-49b0-8253-cb4a569bacb3;10fe5a3b-84dc-4600-87c2-b80c97ce18cf;120ce39a-c2bc-4c07-94b5-c7d9fc0da7ec;1acbda65-ead7-4947-841c-8788c3ee4c00;1f2cc2d9-73d5-4539-8a0c-dba24ae4b10d;281ab967-7565-4bef-9c0c-a646589c671e;290a91e5-22ae-4d62-ab34-39a3117002e2;2fac670c-88f2-4f19-9538-678b6bfe23f5;30e64a3c-2045-405b-a22c-a1a6ba80c51e;3115aef0-fd50-4ec8-a064-3effb695f3f2;3848bfdc-21e6-4eef-a731-eec14ad39793;43b54d0d-9c26-4e72-947b-0009a0a18409;4c918ddf-2d16-49eb-b2a8-d0e00fd6b178;5092299c-3782-4ee5-b3e7-4e80bf378e3b;599fc1cd-0334-4be1-8c3d-a7f184f4b904;5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f;635e93eb-9c12-7ead-b81e-bc06603c526d;63e2d3c7-8120-401b-a826-c98754797026;64ea4cd0-ba01-4c3a-8ef2-41d7b3073f8f;66dc04d3-54ea-41f8-9495-81565b03dc9a;6984a178-7903-4881-98be-76e337565c6d;78fb9762-c2b2-4e32-ac4c-e95cba11198e;947f2aa0-4d8e-4e8d-b8fe-601d50be3bc4;97c28049-1f40-4b0c-9caa-eb0770d0300d;99385bc6-e9b5-4081-831d-657bf3dfbaaf;9a76c658-6658-47a7-8f8d-b3994aef8585;9b682e76-7b10-43a9-9527-81a633b7d0c0;9fcd7814-1363-4218-92c6-b0f732795897;9fde9268-d5e8-4402-a429-df55f075861d;A784F545-F209-46D4-9350-AE64FAD9E07C;a1769552-f230-40e0-8f05-5b3b356437b6;a651e06c-6295-4ed2-8d67-334645f05b30;aa0b1582-6ef3-4697-9ea6-5391e6e57853;add8f32a-4a63-4180-8d92-d34a75e498de;b4332b67-833d-4838-9594-b2b76f98d1ab;b44702ca-0f0f-4180-9462-3e5c932c999e;b8bb74be-9a37-44ec-a7cd-58f2cf99ac75;c308ffd5-208e-4661-8451-2c6ea6594d08;c8bc83d5-b9e2-4d31-a3df-8e899aac1ba5;c960d736-2657-4b79-967f-d2c9bb4076cd;d29348a5-e903-4145-9dbd-ce604e666992;d3abe47f-8ad5-4752-b772-97b56cca19f2;db320bf8-10b5-4f2d-bce5-04e87dfd2db4;e0be1cf5-b4e4-4c07-8cfb-11f414856c80;e419b13a-68de-4d24-ba8e-3257e88905a3;e63df4be-b3d3-4873-92e3-d7fbc84d1dc4;e9d6774e-45f6-419f-b388-8dfb4dd34944;eab763ec-04bf-4e57-8351-a1d0de0c3811;f285bc65-ed88-488d-8fce-a3a608ed0514;f4a4cf97-6b6d-4406-a141-7d6a087667aa;f55cecd1-013d-4db5-9d62-e2cd53f253e4;f696623f-ecf2-407a-a676-caad2f4c0123;fb95ae26-70e8-417b-98aa-657e3dd668d7; |
Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. |
Annotated Indication CUIs: C0027497;C0036341;C0042963; |
RXCUIs for this Label: IN=8076 SCDF=373299; SCD=198075;198076;198077;198078; |
Similar Labels: 2d821387-4b4f-4fe3-825e-750f49755baf;6beb0c1a-9801-40d9-97d5-3488e603cc1a;6c76e98d-b8c3-441f-bac5-a9de6dc8f14f;a17c90f9-3d5d-4503-ba2c-754b45decbf8;abcfeec6-7f3a-4139-a6e6-fa42dafd8264;ad8193fb-4e3c-42e9-a4a8-49133650b86b;ca1b6a78-739b-4e2a-9332-145c887fb2ff;d09dd18f-8db4-4fee-b51c-6aba56850103;dd02a11f-6ea6-42e7-b168-bf2b9f4d54ae;f2c7e54b-ed7c-4d8f-a86d-5099a8b52f28; |
For the relief of mild to moderate pain. |
Annotated Indication CUIs: C0278138;C0278139; |
RXCUIs for this Label: IN=8785 SCDF=373641; SCD=849279; |
Similar Labels: 11476433-d06d-4b33-924f-e8066bca7455;22734527-78ad-4075-bcd5-3e6d535c61e9;49c4f24c-648b-2db2-5c00-2835d14b1275;773c3627-1635-4415-a89a-aaf74329f9c2;e83c5fef-74e9-46ed-8277-063df09a1e3d; |
Primary Hypercholesterolemia or Mixed Dyslipidemia TRICOR is indicated as adjunctive therapy to diet to reduce elevated low density lipoprotein cholesterol (LDL C), total cholesterol (Total C), Triglycerides and apolipoprotein B (Apo B), and to increase high density lipoprotein cholesterol (HDL C) in adult patients with Primary Hypercholesterolemia or mixed Dyslipidemia. Severe Hypertriglyceridemia TRICOR is also indicated as adjunctive therapy to diet for treatment of adult patients with severe Hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Important Limitations of Use Fenofibrate at a dose equivalent to 145 mg of TRICOR was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)] . |
Annotated Indication CUIs: C0242339;C0020557;C0342879; |
RXCUIs for this Label: IN=8703 SCDF=379818; SCD=477560;477562; |
Similar Labels: 13d99b6b-99a5-49e7-8288-f07a087e344c;1f841079-8c66-4f93-a244-4c405d01e364;319a178d-7ffb-4466-85f6-de615d02f223;35e89d4e-45cf-4374-bf93-fca8d40d783b;45364845-c3b4-40a1-a677-82202ffaa5ad;5d4be1cd-0d85-ea9b-f408-a62582069d0c;6FE11357-7165-4C8B-BE0A-42C277A12BF9;86c49aff-0a4a-46b5-ac6e-26789bf17c9b;94a4a99b-24df-4e81-b409-5325d36647d2;9a883573-aa2a-4376-bb0f-3b88246d2169;9d4fa3ac-5a6d-460c-bc89-1c83fd436e90;b38489c0-ee7b-11df-b958-0002a5d5c51b;b693e68d-f812-4993-54b6-852e3517c344;ddb63851-e9b9-4ab0-8e6d-6f83d79741e5; |
OxyContin Tablets are a controlled release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time. OxyContin is NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non opioid analgesics, such as non steroidal anti inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for HealthCare Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. OxyContin is not indicated for pain in the immediate postoperative period (the first 12 24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.) |
Annotated Indication CUIs: C0278139;C0278140;C0030201; |
RXCUIs for this Label: IN=7804 SCDF=385094; SCD=1049599; |
Similar Labels: 000dde4b-1d94-442f-94c0-26e283e04d88;0b46314b-604d-48ed-9d31-83a18ef4134c;215fc8cf-92a0-98d6-c084-3575882f0a66;240118ae-2cf5-4e48-a182-7c37026d59b5;30D32796-AB7E-4765-B121-09277E1C1396;43aab72d-0160-3cc0-0069-8d2a98703364;46345ce2-4038-4928-916d-f3764bddf456;5d1e0e59-f3af-496d-a878-547b5467cd99;66b1190e-a11d-4005-bb95-fa32a0e2de1e;6a30d67a-49ae-4d5c-8b60-5bc8453e9341;6dbf24ce-1200-49ea-95ad-9a06f6db3c1b;88603d5f-4ad0-46ab-999f-740312dc35dc;8c9cb953-0995-4f47-83ee-c8c9dfd1b533;9a3ca129-d6f0-47e4-9f79-f7f9b3fd8692;a1b2e514-b75d-4f01-a9fd-83151f0ce813;aa4d77fb-8d49-4212-8535-9ab8ea7e30d5;bb59f14c-7c7c-4c05-8c5b-41ed92596909;d1f543fe-ebfb-4ace-a223-d928d6b648c1;d7aad54a-541f-41c6-85c9-712c88d3ba30;e18d23e3-b4b2-483f-9523-fdc2b10c6978;f06d3690-3fd4-407d-8f8d-ab0c354e61bd; |
Oxycodone hydrochloride oral solution 100 mg 5 mL ( 20 mg mL ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid tolerant patients. Oxycodone hydrochloride oral solution 100 mg 5 mL (20 mg mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. |
Annotated Indication CUIs: C0278140;C0184567; |
RXCUIs for this Label: IN=7804 SCDF=373196; SCD=1049615; |
Similar Labels: 6869fec9-1837-4221-afd8-5cc6fadd025d;7290eb06-641a-43df-9a23-74288ca1e25d;7c686a46-1f5f-46e3-945b-2ade3931718f; |
Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms AEROBIC GRAM POSITIVE MICROORGANISMS Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Groups C F) Streptococcus (Group G) Viridans group streptococci AEROBIC GRAM NEGATIVE MICROORGANISMS Acinetobacter iwoffii * Haemophilus influenzae Serratia marcescens * *Efficacy for this organism was studied in fewer than 10 infections. |
Annotated Indication CUIs: C0009768; |
RXCUIs for this Label: IN=82122 SCDF=376884; SCD=314080; |
Similar Labels: 6987500a-2feb-48a9-9d29-89693333a801;f79d2ae4-ccfb-49ca-bf0e-e505f3477d30; |
Co administration Therapy with Statins for the Treatment of Mixed Dyslipidemia Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL C in patients with mixed Dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL C goal. CHD risk equivalents comprise
Treatment of Severe Hypertriglyceridemia Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe Hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied. Treatment of Primary Hyperlipidemia or Mixed Dyslipidemia Trilipix is indicated as adjunctive therapy to diet to reduce elevated LDL C, Total C, TG, and Apo B, and to increase HDL C in patients with primary Hyperlipidemia or mixed Dyslipidemia. Important Limitations of Use No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus. General Considerations for Treatment Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy. Every reasonable attempt should be made to control serum lipids with non drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate Hypertriglyceridemia (beta blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride lowering drug therapy is considered. If the decision is made to use lipid altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL. |
Annotated Indication CUIs: C0242339;C0020473;C0020557; |
RXCUIs for this Label: IN=8703 SCDF=439656; SCD=828373; |
Similar Labels: 3057fc9c-ff77-43eb-b687-776660423742;bbf3e782-d163-49c8-0e81-4eeabef48190; |
Phenytoin Sodium Injection is indicated for the control of status epilepticus of the grand mal type and prevention and treatment of seizures occurring during neurosurgery. |
Annotated Indication CUIs: C0014549;C0036572;C0038220; |
RXCUIs for this Label: IN=8183 SCDF=373436; SCD=855889; |
Similar Labels: 01ab131c-7b06-4982-8cf0-4e60879e0c8c;035a8d4e-2063-4240-83cb-d7eebcabe301;313cb886-326c-4f27-9b7f-85d94b7e04b8;31d00e75-4fe0-4aec-9cba-c86cb78762c5;41eecbfb-b03a-4a98-ea83-8d4e347f80f6;4fecb867-7213-49ce-9d8f-433f157635d1;7317e374-847a-4b8a-851d-467a0bb9c77e;7806b2aa-074d-43fd-bc8a-7266389b0d26;ab923d09-747d-4527-9bdf-2c807a5775d2; |
AZULFIDINE EN tabs Tablets are indicated
In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti inflammatory drugs, AZULFIDINE EN tabs does not produce an immediate response. Concurrent treatment with analgesics and or nonsteroidal anti inflammatory drugs is recommended at least until the effect of AZULFIDINE EN tabs is apparent. |
Annotated Indication CUIs: C0553662;C0003873;C0009324; |
RXCUIs for this Label: IN=9524 SCDF=376645; SCD=313142; |
Similar Labels: 257cee60-b68f-4c2b-b57d-8e4d73d17e09;599be7ea-4036-4e43-a411-1c42369b1b8c;b9ef541a-93c8-4428-ba45-398aa0b327d1; |
Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of Secondary Amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%. |
Annotated Indication CUIs: C0232940; |
RXCUIs for this Label: IN=8727 SCDF=377270; SCD=312643;312645; |
Similar Labels: 2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6;7def92fe-d521-41c0-b419-48e028f59f15;9f8dc923-65d7-42ff-b718-97e7a7e87822; |
To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. |
Annotated Indication CUIs: C0027497;C0036341;C0042963; |
RXCUIs for this Label: IN=8704 SCDF=373605; SCD=314192; |
Similar Labels: 016b4aa0-ec8f-4bbc-aa07-58e3da801c3b;5e771ba7-983f-49b4-a1f2-0f335b637433;75a3992d-0d2a-498a-9b82-61ee424f3010;a0e65883-9d67-4569-af69-b6ab7ee4a536;daabf2ee-7f0e-4b45-a2be-8ab6d8c9d3e7; |
Propafenone Extended Release Capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease. The use of propafenone ER capsules in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. Propafenone ER capsules should not be used to control ventricular rate during atrial fibrillation. The effect of propafenone ER capsules on mortality has not been determined (see black box WARNINGS ). |
Annotated Indication CUIs: C0004238; |
RXCUIs for this Label: IN=8754 SCDF=406230; SCD=861164; |
Similar Labels: e4412a6a-ed4d-410d-8abb-86e1d7b72a3c; |
MINIPRESS is indicated in the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs such as diuretics or beta adrenergic blocking agents. |
Annotated Indication CUIs: C0020538; |
RXCUIs for this Label: IN=8629 SCDF=373565; SCD=198141;312593;312594; |
Similar Labels: 021370d8-a61c-4510-b717-40dadcf9a4dc;1ce90aaf-d075-4617-9a47-e8d922096d23;36c4da56-502e-4da1-acf7-8e81ee453dcc;5d7dff44-84b1-4044-bc5a-c76ea11dd5a3;7293cef3-ef9e-40dc-9995-875ef047f693;7dd1b0aa-0d5c-4255-a514-a516f78c0f64;cd52f022-ca29-4f87-8684-da63e05b3c1f;e6a029b2-802f-4cc5-8795-20e177e8d779; |
For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short term treatment of generalized non psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of prochlorperazine as treatment for non psychotic anxiety was established in 4 week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. |
Annotated Indication CUIs: C0003469;C0270549;C0027497;C0036341;C0042963; |
RXCUIs for this Label: IN=8704 SCDF=373609; SCD=198365; |
Similar Labels: 15453da2-c60b-42ca-a997-8ec7bc7dcade;1e660e78-2267-4e3a-bdb9-80041f88cb5f;26b5247a-9590-dd1d-7101-e406011d20e3;27c6d7d9-78f1-485f-adbb-506fd1aa8e5c;2fd7803f-fb1f-4f00-86ad-c2436b569e6d;5cfd84b0-46a3-4379-9454-62f183370a76;6b0e958b-fde0-74ea-b196-1e62f90b5bbe;718c6fee-77d5-4ba1-8a1d-f2ac059298b3;95b54f0a-5e38-4bfa-8c5e-f9c826774da0;a49905cc-dd53-43a2-8113-d8ada3f8cae9;b05bc20e-cd19-ab40-1ad0-84a115d6d69e;b733d4e1-bd73-43f3-8192-df89cbdae781;c13a266d-a692-4a8e-ba06-2984b287eeaf;d242cfe9-6aab-4c02-ab84-f4fb2f73be93;d2e353a9-ac30-4378-af05-189b54b63e53;e4f4d30e-4bb8-411c-a0d3-0be160f6745e; |
OxyContin is the management of moderate to severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. Limitations of Use OxyContin is not for use
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Annotated Indication CUIs: C0278139;C0278140; |
RXCUIs for this Label: IN=7804 SCDF=385094; SCD=1049502;1049543;1049557;1049563;1049574;1049584;1049593;1049599; |
Similar Labels: bfdfe235-d717-4855-a3c8-a13d26dadede;dce87c26-26d2-4546-8a9a-e2267630abc8; |
Prochlorperazine 25mg suppositories are indicated in the control of severe nausea and vomiting in adults. |
Annotated Indication CUIs: C0027497;C0042963; |
RXCUIs for this Label: IN=8704 SCDF=373608; SCD=198159; |
Similar Labels: 9595346e-76e5-e155-341b-ffaaafb885ab;99d9e8a9-e299-4ee4-9f04-a82a83845594;b23b67eb-78b7-48eb-84ff-c95d3ce8683c;ea381bc5-0957-4c91-826a-0ff680cebacc; |
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Annotated Indication CUIs: C0234533;C0751495; |
RXCUIs for this Label: IN=8134 SCDF=435437; SCD=702519; |
Similar Labels: 069b92ce-0061-4724-8c25-08d8596770a2;073b9e2d-b183-4e20-b8ce-fd3ab07588da;0e2ce036-5b74-4aa6-8a6b-57452315b769;7f022b36-494f-49da-b09d-82413a507392;b7392fd2-4380-4b25-9205-324f9897716b;e8e1b3d7-0272-4278-b2a3-1d10dbeb0a5a;e8f17385-5731-4cce-87bb-768b817dfa8d;f2cfc093-fdf9-4263-a9f2-ee33d8742204;ff602c63-870a-4a32-b14e-27dbfb34151f; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of LEVAQUIN and other antibacterial drugs, LEVAQUIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. LEVAQUIN Tablets Injection and Oral Solution are indicated for the treatment of adults ( 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. LEVAQUIN Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4) ] . Therapy with LEVAQUIN may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN . Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. Nosocomial Pneumonia LEVAQUIN is indicated for the treatment of Nosocomial Pneumonia due to methicillin susceptible Staphylococcus aureus , Pseudomonas aeruginosa , Serratia marcescens , Escherichia coli , Klebsiella pneumoniae , Haemophilus influenzae , or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti pseudomonal lactam is recommended [see Clinical Studies (14.1) ] . Community Acquired Pneumonia 7 14 day Treatment Regimen LEVAQUIN is indicated for the treatment of community acquired pneumonia due to methicillin susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multi drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae , Moraxella catarrhalis , Chlamydophila pneumoniae , Legionella pneumophila , or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)] . MDRSP isolates are isolates resistant to two or more of the following antibacterials penicillin (MIC 2 mcg mL), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim sulfamethoxazole. Community Acquired Pneumonia 5 day Treatment Regimen LEVAQUIN is indicated for the treatment of community acquired pneumonia due to Streptococcus pneumoniae (excluding multi drug resistant isolates [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Mycoplasma pneumoniae , or Chlamydophila pneumoniae [ see Dosage and Administration (2.1) and Clinical Studies (14.3) ] . Acute Bacterial Sinusitis 5 day and 10 14 day Treatment Regimens LEVAQUIN is indicated for the treatment of Acute Bacterial Sinusitis due to Streptococcus pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies (14.4) ] . Acute Bacterial Exacerbation of Chronic Bronchitis LEVAQUIN is indicated for the treatment of acute bacterial exacerbation of Chronic Bronchitis due to methicillin susceptible Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Haemophilus parainfluenzae , or Moraxella catarrhalis . Complicated Skin and Skin Structure Infections LEVAQUIN is indicated for the treatment of complicated Skin and Skin Structure Infections due to methicillin susceptible Staphylococcus aureus , Enterococcus faecalis , Streptococcus pyogenes , or Proteus mirabilis [see Clinical Studies (14.5) ] . Uncomplicated Skin and Skin Structure Infections LEVAQUIN is indicated for the treatment of uncomplicated Skin and Skin Structure Infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin susceptible Staphylococcus aureus , or Streptococcus pyogenes . Chronic Bacterial Prostatitis LEVAQUIN is indicated for the treatment of Chronic Bacterial Prostatitis due to Escherichia coli , Enterococcus faecalis , or methicillin susceptible Staphylococcus epidermidis [see Clinical Studies (14.6) ] . Complicated Urinary Tract Infections 5 day Treatment Regimen LEVAQUIN is indicated for the treatment of complicated Urinary Tract Infections due to Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis [see Clinical Studies (14.7) ] . Complicated Urinary Tract Infections 10 day Treatment Regimen LEVAQUIN is indicated for the treatment of complicated Urinary Tract Infections (mild to moderate) due to Enterococcus faecalis , Enterobacter cloacae , Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , or Pseudomonas aeruginosa [see Clinical Studies (14.8) ] . Acute Pyelonephritis 5 or 10 day Treatment Regimen LEVAQUIN is indicated for the treatment of Acute Pyelonephritis caused by Escherichia coli , including cases with concurrent bacteremia [see Clinical Studies (14.7 , ] . Uncomplicated Urinary Tract Infections LEVAQUIN is indicated for the treatment of uncomplicated Urinary Tract Infections (mild to moderate) due to Escherichia coli , Klebsiella pneumoniae , or Staphylococcus saprophyticus . Inhalational Anthrax (Post Exposure) LEVAQUIN is indicated for Inhalational Anthrax (post exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . The effectiveness of LEVAQUIN is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEVAQUIN has not been tested in humans for the post exposure prevention of inhalation anthrax. The safety of LEVAQUIN in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEVAQUIN therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1 , 2.2) and Clinical Studies (14.9) ] . Plague LEVAQUIN is indicated for treatment of Plague, including pneumonic and septicemic plague, due to Yersinia pestis ( pestis ) and prophylaxis for Plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of LEVAQUIN could not be conducted in humans with Plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [ see Dosage and Administration (2.1 , 2.2) and Clinical Studies (14.10) ]. |
Annotated Indication CUIs: C0694549;C0275556;C0008677;C0949083;C0037278;C0021311;C0000833;C0007642;C0242301;C0021099;C0034212;C0043241;C0520575;C1720797;C0155866;C0032064;C0042029;C0004610;C0152936; |
RXCUIs for this Label: IN=82122 SCDF=372588;377141;477392; SCD=199884;199885;199886;311296;477391;895915; |
Similar Labels: 0818c344-2fc5-4cee-ac06-c9cd7fd07680;0a997a7b-4735-44c9-9b8c-1aa493c70d43;111ad6f9-170d-4a14-a4e2-ff86f60521cd;139f86a4-75c5-4304-894c-8f8b8a396c78;15a80e60-5d8b-4085-ba4c-7616af1ac96b;1a5eff69-0c4c-4e20-9e04-05db3ebbd589;1fa2c0d2-f22d-4f63-89c3-26e0a4216bfc;27c6c38e-e933-4fe7-8748-397686177036;312e65cb-897f-4c24-b17b-be7e8ce469bb;34704c52-b71c-4a6d-9335-00cce4ec7302;398348ed-1b65-4109-9d0f-f9d8a7175d61;40a96527-f89e-4177-9224-5c79167f3e60;4438fed2-7ef5-488f-baa8-39bc65768d1d;449ddc89-6dff-4e3e-a480-66b68389c73d;4be13bd5-0c39-43c3-9232-b1226ccd4dbc;529ac72c-c4a0-4001-8cf9-b94f5bf7265c;533260c1-3d9f-4414-a097-068a215876d5;5552141a-82cf-4eb6-a07d-025fea0de716;5dd1f9bb-acbf-4deb-9b02-992d52239a6b;699fbdb8-a6fd-476a-9b80-08197d869534;6ee54fdc-efe6-4411-a711-8154ceee20b6;71d4bca8-0b51-8f0a-ebab-a67c52fff3b7;9b59428a-a23a-b2d9-982f-98f8a1ed381f;9f852453-5d49-4a83-bba9-54aa454d0c2b;a1f01e8e-97e9-11de-b91d-553856d89593;a23a1cca-bc3e-48c5-abd9-82eddb52e91b;a3b199d0-4ed4-4392-8db6-3ed9fc48db07;b124dded-a848-4a7e-b5cd-05797774b6ad;b95172dd-ff18-4323-a605-ed5ae58a69ed;bb5e3b54-4dd8-478d-9d88-786114be9ce2;be2a14b5-8dc0-473e-8672-96297e20e199;c6c7322b-6a89-4d23-90d1-bf9327bd6d91;d334f6d6-f6a6-4a5e-a5d6-92bf450c0f5b;d85c5ab8-a3d8-42a3-ac0b-799ea5a6369e;dd902513-1411-4746-8f45-f7f3fb68f130;e4bf3611-c2b6-4397-a786-ea022f86d7f8;e680c759-16c5-4532-9c9c-f42c8c3df74a;ea29921d-ae91-4a1b-a8e5-5c00a16be127;eb5c26fc-4201-4b1a-a359-bc9bb3985522;ec61dd9d-a016-4740-b9b8-20754e50be98;fa7ddbd9-29e2-4a36-af46-00c96a77ac85; |
Treatment of Hypercholesterolemia Triglide is indicated as adjunctive therapy to diet for the reduction of LDL C, Total C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines , below). Treatment of Hypertriglyceridemia TRIGLIDE is indicated as adjunctive therapy to diet for treatment of adult patients with Hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides ( e.g. > 2,000 mg dL) may increase the risk of developing pancreatitis. The effect of TRIGLIDE therapy on reducing this risk has not been studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia (Nikkila, 1983). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in Hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of Hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. (See WARNINGS and PRECAUTIONS ). |
Annotated Indication CUIs: C0020443;C0020557;C0020480;C0020473;C0242339;C0342879; |
RXCUIs for this Label: IN=8703 SCDF=379818; SCD=349287;577031; |
Similar Labels: 04cbb126-4357-42f6-9c89-6fa9ff475b34;194cd14a-d952-4507-91be-3f1d5371d3b8;1ecb628e-8bdf-4dbc-b5be-9f40eec183e6;24790a18-0291-4b88-a724-acac43b616ce;2e51aa89-684d-451e-b513-12b00bf9aea0;65AFA805-603A-43DE-9651-D04E49BD2AA7;680a6740-8ea8-4a06-b659-41c2e5b1a4fd;77e40fef-78a7-4f60-9632-1cc9b66acd71;806969c4-7702-484a-811d-fe01baa163c6;ACCA05AB-185B-41A6-9CE2-783FC3C3CF96;a7f3a0c2-1444-4178-9d8d-20c2ea2e45b7;a9c5062d-e8ad-44e7-a709-af0092f73d52;bfc6668c-3f69-4dd3-bc19-0d26c23dd04c;c3afa988-d258-4e83-89ed-d674743109c4;c53c20ed-a944-4b35-b5db-91d9f67240e8;c850d4e4-2dce-4a03-964f-b9397ec20514;d5dba7f7-fbd6-47c0-a945-4f1ed5b410b8;dc03eb20-7a97-4e82-a060-7b8062474f4f;e55be390-e4e5-4c45-a21b-7c0198d92d35;e5e78bfc-1b18-46fa-aebd-f8ae313960c1;fa08cf6a-d306-4979-9b23-ac7febf4fd12; |
Parenteral
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Annotated Indication CUIs: C0751495;C0494475;C0003469;C0018801;C0008489;C0086439;C0085580;C0019080;C0020550;C0917801;C0022893;C0026603;C0027497;C0152163;C0042963; |
RXCUIs for this Label: IN=8134 SCDF=373325; SCD=198368;312370; |
Similar Labels: ffcaa218-ed6a-4557-9645-b9a91128a214; |
Propylthiouracil is indicated in the medical treatment of hyperthyroidism. Long term therapy may lead to remission of the disease. Propylthiouracil may also be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Propylthiouracil is also used when thyroidectomy is contraindicated or not advisable. |
Annotated Indication CUIs: C0020550; |
RXCUIs for this Label: IN=8794 SCDF=373658; SCD=198175; |
Similar Labels: c46c4f31-121c-43a8-9538-53ae1288812e; |
CODRIX is indicated for the relief of mild to moderately severe pain. |
Annotated Indication CUIs: C0278138;C0278140; |
RXCUIs for this Label: IN=2670 SCDF=370754; SCD=994049; |
Similar Labels: 18315a6f-9e89-46d7-81d3-905b8a51aa79;31d4cf3e-a903-4a43-bd44-73fbffc424b3;453f8966-f89c-4ab2-b91e-c7bb50304028;632c566c-39fb-4321-ac56-aea83780fa02;9b3f274c-e7d8-4c67-aa22-bf5aa62064cc;a2ca6210-578d-496c-9a0e-6eb716f87ae6;b7c4c175-d3f9-4ed8-abb8-cfb33b9dc2b3; |
To reduce the development of drug resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of Urinary Tract Infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated Urinary Tract Infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media For the treatment of Acute Otitis Media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension, USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension, USP is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults For the treatment of acute exacerbations of Chronic Bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim oral suspension, USP offers some advantage over the use of a single antimicrobial agent. Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia. Traveler's Diarrhea in Adults For the treatment of Traveler's Diarrhea due to susceptible strains of enterotoxigenic coli. |
Annotated Indication CUIs: C0271429;C0008677;C0013371;C0277528;C0042029;C0042029; |
RXCUIs for this Label: IN=10829 SCDF=374233; SCD=313134; |
Similar Labels: 002e3d65-894e-4778-8945-01e71e29e288;00add4a1-377c-4971-8924-65bb1aa25f2a;0138a156-859a-48a3-bf5a-e2db0cc7f2f9;050b2f4e-d653-46ef-8235-4361598888c4;06e3d76b-8f16-4d53-bb9f-201cb6a72fb8;09086798-2dc3-4a0d-a02a-304baec56b72;094071bc-c445-4d09-b8d7-d1517c3a8946;0c3ab79b-cdf4-4a67-b6d9-6c89d7cd4fc1;12c87ae8-0fa2-4c3f-92c4-7d0042ac23b1;1d3e46c4-6652-44c9-8aa6-2bae30d4b246;24b0946d-25dd-457b-b1bf-7fbc7521a84b;27ca999f-2678-4c7d-8f7d-895d0fe77a9f;284b5dac-2b8d-46bf-95fe-80ce03fa178a;2bc4adb5-cac5-4b8b-bc92-35bcc0321e82;3233c54d-484d-4550-b172-db8af47d1b7f;32e2b197-e171-444d-86ca-198d4c84d7a5;38f42bad-6b2a-423d-af66-0e526ba03da1;3e568a2e-421d-4456-a8bf-d983ecee7ad6;4833319a-a7b3-4bf4-bec4-6531b43182d4;52742743-e657-42a6-bd8f-b53c112ef317;5e9d036b-1c69-4cf0-9b8e-ebc1c7f2a954;78581094-bd77-4276-8416-246293907165;84d78cde-110a-448b-b7ee-cfa69cdc4f32;897e4438-ba93-4d47-9d33-6ad1afcd7c25;8fa9225f-dd1a-4225-a2b3-34535451b473;93374337-1499-4225-9585-3b3d20371d84;97617d50-3193-4548-8c38-7ff029d0b0a4;A8DF90D8-78B3-48C3-B42E-1E651D81454B;a03f40f5-068e-41f2-826d-6ed627dd8776;a174991a-53e7-c791-3cee-b706a48e0ec5;a2978977-8ae3-438e-9059-ea8bda49741d;a349e15a-f29b-42b6-5699-77156e198f32;a6182855-6287-45e9-b6b4-7b57efc9c76e;a6f10209-1b12-43dc-bf18-00124d89e27d;aa547448-26c1-4482-8d5d-3cf7d6b1a28a;abe0d2d5-4879-4b4e-9b57-47ea83a17ba0;afb1693a-63d4-4356-976a-51a2d8dcde68;b1645c68-9dfc-4079-8bf0-e61e9b2e4ed0;bcbdbb65-3d82-42e8-9564-630748549954;bf3bab33-55c3-4738-9ea2-b687f640ca39;c12366c1-2e7f-426d-b5ca-bba7b460fbe8;c135323a-33dd-49d5-b55a-33e1ff1b78fd;c62ad12d-a7c1-4846-9dbf-6e11884000bc;c8833d0d-9e8e-40cf-b6df-d559ea83b7b2;c9676c8a-4597-4dcf-8944-18ecc96004e2;cbf74e0d-3254-4ed4-b5bd-d6eeaa1efec0;d9f571b7-0933-4efa-9c0f-402b83c060cf;dc9e3ad3-9599-420a-9697-95bb5a452652;dff887ee-43c7-40fc-9c5f-76014616c461;e0cd17c8-0e88-4a72-baef-969fefa5efe6;f1a64637-6143-4543-a785-12e006cba849;f8f30cc7-94e3-49f4-84c5-1f43ccdabc35;fad287b4-8294-40ce-b49d-1b4adc58942a;fea44910-400c-4688-bedc-bbb1615cd8f5;ff0b3cd5-c9cd-42df-b72f-4c69e76c7bd9; |
VIAGRA is indicated for the treatment of erectile dysfunction. |
Annotated Indication CUIs: C0242350; |
RXCUIs for this Label: IN=136411 SCDF=373871; SCD=314228; |
Similar Labels: 03bdf36c-0cae-4d4f-b85d-99078bc12d11;0b0be196-0c62-461c-94f4-9a35339b4501;1da7847b-16e4-4bf1-957f-3894d023b339;40fa9a7d-749a-46c5-931c-4e187f7a00df;442a09ee-e7de-4d53-a32e-07c7530cdede;4d60822d-1c9b-494d-adb3-20fe921d9c58;a2a9f459-e692-4e85-83b0-a35fbf35e91b;c6c048ec-0b99-4fa4-9df7-9926db93749b;fe24cae8-fb13-4f01-aa72-0ea929a432ef; |
Major Depressive Disorder Sertraline hydrochloride tablets are indicated for the treatment of Major Depressive Disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM III category of Major Depressive Disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open label acute treatment (52 weeks total) was demonstrated in a placebo controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY ). Obsessive Compulsive Disorder Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM III R; i.e., the obsessions or compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride tablets were established in 12 week trials with obsessive compulsive outpatients having diagnoses of obsessive compulsive disorder as defined according to DSM III or DSM III R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY ). Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego dystonic and or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride tablets in maintaining a response, in patients with OCD who responded during a 52 week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY ). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Panic Disorder Sertraline hydrochloride tablets are indicated for the treatment of Panic Disorder in adults, with or without agoraphobia, as defined in DSM IV. Panic Disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride tablets were established in three 10 to 12 week trials in adult Panic Disorder patients whose diagnoses corresponded to the DSM III R category of Panic Disorder. Panic Disorder (DSM IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride tablets in maintaining a response, in adult patients with Panic Disorder who responded during a 52 week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient. Posttraumatic Stress Disorder (PTSD) Sertraline hydrochloride tablets are indicated for the treatment of Posttraumatic Stress Disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PTSD was established in two 12 week placebo controlled trials of adult outpatients whose diagnosis met criteria for the DSM III R category of PTSD). PTSD, as defined by DSM III R IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open label treatment was demonstrated in a placebo controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient. Premenstrual Dysphoric Disorder (PMDD) Sertraline hydrochloride tablets are indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PMDD was established in 2 placebo controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM III R IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY ). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride tablets in long term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Social Anxiety Disorder Sertraline hydrochloride tablets are indicated for the treatment of Social Anxiety Disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride tablets in the treatment of Social Anxiety Disorder was established in two placebo controlled trials of adult outpatients with a diagnosis of Social Anxiety Disorder as defined by DSM IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY ). Social Anxiety Disorder, as defined by DSM IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with Social Anxiety Disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride tablets treatment was demonstrated in a placebo controlled trial. Physicians who prescribe sertraline hydrochloride tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY ). |
Annotated Indication CUIs: C1269683;C0028768;C0024517;C0038436;C0030319;C0520676;C0031572; |
RXCUIs for this Label: IN=36437 SCDF=373868; SCD=312938;312940;312941; |
Similar Labels: 966d728e-87ca-4491-9411-2ec253eca632; |
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). Allopurinol is indicated in
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Annotated Indication CUIs: C0149896;C0409908;C0042018; |
RXCUIs for this Label: IN=519 SCDF=370547; SCD=197319;197320; |
Similar Labels: 0b7f42cf-e71d-465c-ba81-23b2ff37fbdc;19a138b8-d225-03e6-f762-abe71560204b;1ce96b87-323d-40b6-a40b-32821e00d94c;2298ed2a-e01b-4f7c-9902-7c58a6e06b7a;29ad13a3-206e-4bb1-b0bf-327e576dee64;30140d33-3a41-40b0-9877-a5d62d6c0e12;342832b5-1a32-4bea-bc49-ab0fd152154e;35707dc4-4897-2452-74c0-0704a80c5036;3df46df4-8b14-459f-949b-dc1f94a07330;40f39058-bfff-4d16-b448-9bbf1c3ebeb0;548f6fbb-155f-45ff-ab44-0a70adad4424;5e8b13b7-ce34-4641-a7f2-d64b7baf31c4;5f9f30a2-085f-473e-9195-500a2068b836;6bbb8947-4f93-4f2a-b205-f4594908aecc;7003e410-b4ff-da07-5571-07e7e13f67e0;72c1078a-55aa-4f81-9c3c-bb086575138e;73cd79c1-6bab-4d7b-ae8b-0176efbaf5b9;7a072f02-05ac-4ce0-8fa4-04a2ad8986fb;81167e87-b1d5-44df-99aa-a033825634dd;8357fbc6-9a5b-4d06-bb99-0bc21ddbdc7d;8afe0c86-00c5-452f-b7b4-7ae81b7da131;939ebead-a5b1-4c3b-a1f5-5225fb60fd38;994b3117-b83e-44d9-910c-1c3a26ef838e;a4595942-a75a-4ac1-b70e-4829edecf1c8;a80fe56f-8d03-423f-8e2a-7ec8c9e5045b;b777d814-8892-43b8-8c4a-6fd11bc97666;bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480;c4cbe7cc-c160-4d46-aad3-61aefe90b3d8;c58b2502-67fa-4535-97a0-4c6b4043a38f;c65e6179-1ee0-4e35-9b12-0a8a55ab9503;c87fceaa-0e56-4042-95a2-08e7c0d6bc47;da5833e4-1a6a-4978-bc9e-3045f774922a;e054ec39-06e2-43ec-88cc-28095f76c6f5;e1f42971-8169-4053-9857-585cef2ba7b0;f213bf75-f514-4bd7-9c64-5f425214134c;fbac3b4f-dc23-4359-ac3f-2b3fdde41af2;fd8f8b8b-f25e-46e9-969a-65363b66e09b; |
The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression. Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus. Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated: 1. The acutely disturbed or hysterical patient. 2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens. 3. As pre and postoperative and pre and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis. Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy. (See CONTRAINDICATIONS ). In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate. Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease. Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent. The effectiveness of hydroxyzine in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0001973;C0003469;C0001957;C0042963;C0677660;C0027497;C0085631;C0233494;C0087169; |
RXCUIs for this Label: IN=5553 SCDF=370661; SCD=995285; |
Similar Labels: 5209ce5b-c14f-44d8-add5-e4de41dc6684;7def1daa-c800-4263-9526-eac8d53e4636;8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a;9c6ec419-5d3b-4053-9970-42a30458b92a;aed7d120-5f3d-4276-b341-737244d4f8a5;ba605c0d-7185-4195-965d-379990eb4b4e;d834dad1-aedc-48d8-941d-3de56ce04069; |
1.1 Hyperlipidemia and Mixed dyslipidemia CRESTOR is indicated as adjunctive therapy to diet to reduce elevated Total C, LDL C, ApoB, nonHDL C, and triglycerides and to increase HDL C in adult patients with primary Hyperlipidemia or mixed dyslipidemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate. Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia (HeFH) Adjunct to diet to reduce Total C, LDL C and ApoB levels in adolescent boys and girls, who are at least one year post menarche, 10 17 years of age with heterozygous Familial Hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. 1.2 Hypertriglyceridemia CRESTOR is indicated as adjunctive therapy to diet for the treatment of adult patients with Hypertriglyceridemia. 1.3 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) CRESTOR is indicated as an adjunct to diet for the treatment of patients with Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.4 Homozygous Familial Hypercholesterolemia CRESTOR is indicated as adjunctive therapy to other lipid lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL C, Total C, and ApoB in adult patients with homozygous Familial Hypercholesterolemia. 1.5 Slowing of the Progression of Atherosclerosis CRESTOR is indicated as adjunctive therapy to diet to slow the progression of Atherosclerosis in adult patients as part of a treatment strategy to lower Total C and LDL C to target levels. 1.6 Primary Prevention of Cardiovascular Disease In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age 50 years old in men and 60 years old in women, hsCRP 2 mg L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL C, smoking, or a family history of premature coronary heart disease, CRESTOR is indicated to
1.7 Limitations of Use CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias. |
Annotated Indication CUIs: C0004153;C0342881;C0342882;C0020473;C0020557;C0020479;C0242339;C0038454;C0027051; |
RXCUIs for this Label: IN=301542 SCDF=402354; SCD=859747; |
Similar Labels: e498b80d-7177-4f9d-8471-2e8f913196af; |
1.1 Mania Divalproex sodium extended release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of Mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended release tablets is based in part on studies of divalproex sodium delayed release tablets in this indication, and was confirmed in a 3 week trial with patients meeting DSM IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (14.1) ] . The safety and effectiveness of valproate for long term use in Mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium extended release tablets for extended periods should continually reevaluate the long term risk benefits of the drug for the individual patient. 1.2 Epilepsy Divalproex sodium extended release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium extended release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. 1.3 Migraine Divalproex sodium extended release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium extended release tablets are useful in the acute treatment of migraine headaches. Because it may be a hazard to the fetus, divalproex sodium extended release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment [see Warnings and Precautions (5.2) , Patient Counseling Information (17.3) ] . |
Annotated Indication CUIs: C0349208;C0014544;C0338831;C0149931;C0014553;C0853193;C0005586;C0149958;C0036572;C0014553;C0014553; |
RXCUIs for this Label: IN=40254 SCDF=808572; SCD=1099563; |
Similar Labels: c4ccf549-4324-49b1-8b68-550f8ee2d2e4; |
Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma. |
Annotated Indication CUIs: C1384494;C0476089; |
RXCUIs for this Label: IN=6691 SCDF=378653; SCD=1000131; |
Similar Labels: 0ceb4952-5af3-4b80-b8b5-cea4e9a5486d;2425f944-15d7-4b84-95a0-6538e843f130; |
Sulfasalazine tablets are indicated: b. for the prolongation of the remission period between acute attacks of ulcerative colitis. |
Annotated Indication CUIs: C0009324; |
RXCUIs for this Label: IN=9524 SCDF=373991; SCD=198232; |
Similar Labels: 5cd02f3a-f953-4513-a63a-9c7e84d49f53; |
Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS Ovarian Hyperstimulation Syndrome ), amenorrhea galactorrhea syndrome, psychogenic amenorrhea, post oral contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. Long term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS .) Clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below (see CONTRAINDICATIONS )
Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation inducing drugs). Similarly, there is no standard clomiphene citrate regimen for ovulation induction in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate is not recommended for these uses. |
Annotated Indication CUIs: C0002453;C0032460;C0232940; |
RXCUIs for this Label: IN=2596 SCDF=371571; SCD=1093060; |
Similar Labels: 49860a2f-92f2-4da8-b78f-0efc005d725a;5d544453-f6d4-45a4-9ece-2f705b32011f;DF518802-0EFD-4DA4-816D-65A7E92CECD2;aa0690af-2cb2-48fb-8f12-d81f13d83378;b2f33ee6-0c57-45d9-b8fc-a8daf2a2185c;be399623-6400-475d-93d3-1dedd4d43017;e9950303-9322-4f27-9e28-f1cedaf87b20; |
Major Depressive Disorder Paroxetine tablets, USP are indicated for the treatment of Major Depressive Disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM III category of Major Depressive Disorder (see CLINICAL PHARMACOLOGY Clinical Trials The effects of paroxetine in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine in maintaining a response in Major Depressive Disorder for up to 1 year was demonstrated in a placebo controlled trial (see CLINICAL PHARMACOLOGY Clinical Trials ). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient. Obsessive Compulsive Disorder Paroxetine tablets, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) as defined in the DSM IV. The obsessions or compulsions cause marked distress, are time consuming, or significantly interfere with social or occupational functioning. The efficacy of paroxetine was established in two 12 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM IIIR category of Obsessive Compulsive Disorder (see CLINICAL PHARMACOLOGY Clinical Trials ). Obsessive Compulsive Disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego dystonic and or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. Long term maintenance of efficacy was demonstrated in a 6 month relapse prevention trial. In this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY Clinical Trials ). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Panic Disorder Paroxetine tablets, USP are indicated for the treatment of Panic Disorder, with or without agoraphobia, as defined in DSM IV. Panic Disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and or a significant change in behavior related to the attacks. The efficacy of paroxetine was established in three 10 to 12 week trials in Panic Disorder patients whose diagnoses corresponded to the DSM IIIR category of Panic Disorder (see CLINICAL PHARMACOLOGY Clinical Trials ). Long term maintenance of efficacy was demonstrated in a 3 month relapse prevention trial. In this trial, patients with Panic Disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY Clinical Trials ). Nevertheless, the physician who prescribes paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Generalized Anxiety Disorder Paroxetine tablets, USP are indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of paroxetine in the treatment of GAD was established in two 8 week placebo controlled trials in adults with GAD. Paroxetine has not been studied in children or adolescents with Generalized Anxiety Disorder (see CLINICAL PHARMACOLOGY Clinical Trials ). Generalized Anxiety Disorder (DSM IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. The efficacy of paroxetine in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8 week acute treatment phase while taking paroxetine and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo controlled trial (see CLINICAL PHARMACOLOGY Clinical Trials ). Nevertheless, the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). |
Annotated Indication CUIs: C1269683;C0028768;C0024517;C0270549;C0030319; |
RXCUIs for this Label: IN=32937 SCDF=378925; SCD=314199; |
Similar Labels: 0ae5f19b-e8d5-4ec7-bcf1-697e88c0e66c;3ef42b6a-42d3-468d-afb5-68aaf8dd3f3f;c55cf30f-6d98-4212-86bd-f7f9f08bbce3; |
INDICATIONS AND USAGE Major Depressive Disorder Effexor XR (venlafaxine hydrochloride) extended release capsules is indicated for the treatment of Major Depressive Disorder. The efficacy of Effexor XR in the treatment of Major Depressive Disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM III R or DSM IV category of Major Depressive Disorder (see Clinical Trials ). A major depressive episode (DSM IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two week period depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of Major Depressive Disorder in adult inpatients meeting diagnostic criteria for Major Depressive Disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials ). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in Major Depressive Disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent Major Depressive Disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo controlled trial (see Clinical Trials ). Nevertheless, the physician who elects to use Effexor Effexor XR for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Generalized Anxiety Disorder Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8 week and 6 month placebo controlled trials in adult outpatients diagnosed with GAD according to DSM IV criteria (see Clinical Trials ). Generalized Anxiety Disorder (DSM IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6 month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Social Anxiety Disorder Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM IV (300.23). Social Anxiety Disorder (DSM IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12 week and one 6 month placebo controlled trials in adult outpatients with Social Anxiety Disorder (DSM IV) (see Clinical Trials ). Although the effectiveness of Effexor XR has been demonstrated in a 6 month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Panic Disorder Effexor XR is indicated for the treatment of Panic Disorder, with or without agoraphobia, as defined in DSM IV. Panic Disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and or a significant change in behavior related to the attacks. Panic Disorder (DSM IV) is characterized by recurrent, unexpected panic attacks, ie, a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes. The efficacy of Effexor XR in the treatment of Panic Disorder was established in two 12 week placebo controlled trials in adult outpatients with Panic Disorder (DSM IV). The efficacy of Effexor XR in prolonging time to relapse in Panic Disorder among responders following 12 weeks of open label acute treatment was demonstrated in a placebo controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials ). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). |
Annotated Indication CUIs: C0270549;C1269683;C0030319;C0031572; |
RXCUIs for this Label: IN=39786 SCDF=452534; SCD=313581;313583;313585; |
Similar Labels: f2f03495-12b6-457a-901f-958b9c844bfd; |
Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual (DSM III R) diagnosis of generalized anxiety disorder) or the short term relief of symptoms of Anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Anxiety associated with depression is responsive to alprazolam. Alprazolam tablets are also indicated for the treatment of Panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM III R criteria for Panic disorder (see CLINICAL STUDIES ). Panic disorder is an illness characterized by recurrent panic attacks. The panic attacks, at least initially, are unexpected. Later in the course of this disturbance certain situations, eg, driving a car or being in a crowded place, may become associated with having a panic attack. These panic attacks are not triggered by situations in which the person is the focus of others |
Annotated Indication CUIs: C0003469;C0030319;C0001818;C0011581; |
RXCUIs for this Label: IN=596 SCDF=370548; SCD=308048; |
Similar Labels: 40caec0c-902c-424c-8c87-63878134641e; |
Lorazepam is indicated for the management of anxiety disorders or for the short term relief of the symptoms of Anxiety or Anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C0003469;C0086132; |
RXCUIs for this Label: IN=2670 SCDF=370754; SCD=993770; |
Similar Labels: 3e41c92a-826d-40af-b2c5-b7720dd32657; |
Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 4 years and above with epilepsy. Additional pediatric use information in patients ages 2 to 4 years is approved for Novartis Pharmaceuticals corporation's oxcarbazepine tablets and oral suspension. However due to Novartis' marketing exclusivity rights, this drug product is not labeled for this pediatric age group. |
Annotated Indication CUIs: C0014544;C0751495; |
RXCUIs for this Label: IN=32624 SCDF=373175; SCD=312136; |
Similar Labels: b9e7c593-9499-49c7-8775-1e7761176857; |
1.1 Schizophrenia SEROQUEL is indicated for the treatment of Schizophrenia. The efficacy of SEROQUEL in Schizophrenia was established in three 6 week trials in adults and one 6 week trial in adolescents (13 17 years). The effectiveness of SEROQUEL for the maintenance treatment of Schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)] 1.2 Bipolar Disorder SEROQUEL is indicated for the acute treatment of manic episodes associated with Bipolar I Disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12 week monotherapy trials in adults, in one 3 week adjunctive trial in adults, and in one 3 week monotherapy trial in pediatric patients (10 17 years) [ see Clinical Studies (14.2)] SEROQUEL is indicated as monotherapy for the acute treatment of depressive episodes associated with Bipolar Disorder. Efficacy was established in two 8 week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies (14.2)]. SEROQUEL is indicated for the maintenance treatment of Bipolar I Disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of Bipolar Disorder has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.2)]. 1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric Schizophrenia and Bipolar I Disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric Schizophrenia, symptom profiles can be variable, and for Bipolar I Disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric Schizophrenia and Bipolar I Disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric Schizophrenia and Bipolar I Disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. |
Annotated Indication CUIs: C0005586;C0853193;C0036341;C0236788;C0338831; |
RXCUIs for this Label: IN=51272 SCDF=374646; SCD=312745; |
Similar Labels: c17aa1e0-8b69-4c46-8502-9e3e07d461b3; |
Severe Recalcitrant Nodular Acne Sotret is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Severe, by definition, 2 means many as opposed to few or several nodules. Because of significant adverse effects associated with its use, Sotret should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Sotret is indicated only for those female patients who are not pregnant, because Sotret can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS Skeletal Bone Mineral Density, Hyperostosis , and Premature Epiphyseal Closure ). |
Annotated Indication CUIs: C1274727; |
RXCUIs for this Label: IN=6064 SCDF=370721; SCD=197843;197844;197845;403930; |
Similar Labels: 0018861f-1b9b-431b-84ee-9d34aab615c3;51ff6346-9256-4c01-9f52-417d13f2df05;8d54aab5-3349-4a41-8533-0a566fd7bbaa;a31fd109-d0fd-4ab9-ba98-a3d64333c18d;b2cb63c9-f825-4991-9a2c-6260f1bbcc2c;d5a26c5e-9c3e-4781-8c08-62b91d21a68d;d8429009-c317-4618-a971-b0c6f1280d1a;ee862463-77c0-4694-bba8-97274f13963f; |
Tablets of Mixed Salts of a Single Entity Amphetamine Product are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM IV ) implies the presence of hyperactive impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months lack of attention to details careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months fidgeting squirming; leaving seat; inappropriate running climbing; difficulty with quiet activities; on the go; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM IV characteristics. Need for Comprehensive Treatment Program Tablets of Mixed Salts of a Single Entity Amphetamine Product are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long Term Use The effectiveness of Tablets of Mixed Salts of a Single Entity Amphetamine Product for long term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Tablets of Mixed Salts of a Single Entity Amphetamine Product for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient. |
Annotated Indication CUIs: C1263846; |
RXCUIs for this Label: IN=725 SCDF=376410; SCD=541363;541878;541892;577957;577961; |
Similar Labels: 08f9eb0a-3797-49f6-90e4-9b8732bfc63f;1714de28-482e-463f-e91f-eeaaaa83d17f;24af5ced-ed01-4188-95f0-b6b8e4f70aab;34726042-2386-4c19-abec-440769fff99a;35744538-1704-4ee0-954d-52710cf3456d;3F7F39A5-D5F9-40B3-B20B-55E2C2D4EF3E;4cc84b5d-9b56-4b80-a201-6e4075727d44;72ddd1c9-ddbd-4c95-acd9-003189a353a3;F0FC4960-8262-48E1-805C-DAE63FD045B0;a200fc5e-faab-4471-af77-64da407fa131;afdedf03-f393-454d-9158-99e36071fa93;aff45863-ffe1-4d4f-8acf-c7081512a6c0;c5c2d060-452c-4f76-ad93-2e41fd8f06c2;cffbbb15-d776-41ae-a8a6-687f2c07bfa4;d63a086a-32e2-49e2-949e-64e4c922775a;f55aba1f-9404-4a49-8e3b-7a66ce538c60;f6c30ba1-53d0-4f85-a515-81acfb922e73; |
DILAUDID ORAL LIQUID and DILAUDID TABLETS are indicated for the management of pain in patients where an opioid analgesic is appropriate. |
Annotated Indication CUIs: C0030193; |
RXCUIs for this Label: IN=3423 SCDF=370654; SCD=897702; |
Similar Labels: 8fe59c4d-c80b-4668-a04e-0dfd2b441f29; |
Verapamil Hydrochloride Injection, USP is indicated for the following Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff Parkinson White [W P W] and Lown Ganong Levine [L G L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and or atrial fibrillation are associated with accessory bypass tracts (Wolff Parkinson White (W P W) and Lown Ganong Levine (L G L) syndromes). In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life threatening adverse responses (rapid ventricular rate in atrial flutter fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia asystole see CONTRAINDICATIONS and WARNINGS ), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C. cardioversion capability (see ADVERSE REACTIONS , Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient s response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection. |
Annotated Indication CUIs: C0004238;C0004239;C0039240; |
RXCUIs for this Label: IN=11170 SCDF=377118;727700; SCD=897706;898316; |
Similar Labels: 0644a3a3-1f7e-4e77-b469-7f4b41625baf;1c993365-1b62-4524-e781-d307f28f63bc;9ca35e18-c823-4e4c-bd69-09d333a7f851;c4415ef0-6e41-4fe0-9627-61f283db8a52; |
ONMEL is indicated for the treatment of onychomycosis of the toenail due to Trichophyton rubrum or mentagrophytes in non immunocompromised patients. Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. [ See Contraindications ( 4 ), Warnings and Precautions ( 5 ), Drug Interactions ( 7 ), and Clinical Pharmacology ( 12 ) .] |
Annotated Indication CUIs: C0040261; |
RXCUIs for this Label: IN=28031 SCDF=440925; SCD=992413; |
Similar Labels: a136e22d-ad97-4f4d-b28b-347a3d2a994b; |
Hydrochlorothiazide Capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, Hydrochlorothiazide Capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. |
Annotated Indication CUIs: C0020461;C0020538; |
RXCUIs for this Label: IN=5487 SCDF=370636; SCD=199903; |
Similar Labels: 4a50cc68-af58-44e7-a278-728e781f0d4e; |
Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. |
Annotated Indication CUIs: C0021359; |
RXCUIs for this Label: IN=8727 SCDF=725093; SCD=725094; |
Similar Labels: 2ba50fa9-b349-40cb-9a4b-1af8faa4ec09; |
SPORANOX (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non immunocompromised patients
SPORANOX Capsules are also indicated for the treatment of the following fungal infections in non immunocompromised patients
(See CLINICAL PHARMACOLOGY Special Populations , CONTRAINDICATIONS , WARNINGS , and ADVERSE REACTIONS Post marketing Experience for more information.) Description of Clinical Studies Blastomycosis Analyses were conducted on data from two open label, non concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of Blastomycosis compared with the natural history of untreated cases. Histoplasmosis Analyses were conducted on data from two open label, non concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV infected patients). The median dose was 200 mg day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of Histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV infected patients Data from a small number of HIV infected patients suggested that the response rate of Histoplasmosis in HIV infected patients is similar to that of non HIV infected patients. The clinical course of Histoplasmosis in HIV infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis Analyses were conducted on data from an open label, "single patient use" protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second line therapy for the treatment of Aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail Analyses were conducted on data from three double blind, placebo controlled studies (N=214 total; 110 given SPORANOX Capsules) in which patients with Onychomycosis of the toenails received 200 mg of SPORANOX Capsules once daily for 12 consecutive weeks. Results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 54% of patients. Thirty five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). The mean time to overall success was approximately 10 months. Twenty one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of KOH or culture from negative to positive). Onychomycosis of the fingernail Analyses were conducted on data from a double blind, placebo controlled study (N=73 total; 37 given SPORANOX Capsules) in which patients with Onychomycosis of the fingernails received a 1 week course (pulse) of 200 mg of SPORANOX Capsules b.i.d., followed by a 3 week period without SPORANOX , which was followed by a second 1 week pulse of 200 mg of SPORANOX Capsules b.i.d. Results demonstrated mycologic cure in 61% of patients. Fifty six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. The mean time to overall success was approximately 5 months. None of the patients who achieved overall success. |
Annotated Indication CUIs: C2350529;C0024115;C0339964;C0004030;C0004030;C0005716;C0019655;C0040261;C1274470; |
RXCUIs for this Label: IN=28031 SCDF=370725; SCD=311204; |
Similar Labels: 599dcdd0-df9b-41e2-a767-b1f44f466fbd;6242b7ad-eaa0-a524-b6e0-ec33e63407db;a4d555fa-787c-40fb-bb7d-b0d4f7318fd0;d343050e-00bb-440c-a24b-7cd18c97e184; |
1.1 Schizophrenia Oral ZYPREXA is indicated for the treatment of Schizophrenia. Efficacy was established in three clinical trials in adult patients with Schizophrenia two 6 week trials and one maintenance trial. In adolescent patients with Schizophrenia (ages 13 17), efficacy was established in one 6 week trial [see Clinical Studies ( 14.1 )] . When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5 , 5.6 )] . 1.2 Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy Oral ZYPREXA is indicated for the acute treatment of Manic or Mixed Episodes associated with Bipolar I Disorder and maintenance treatment of Bipolar I Disorder. Efficacy was established in three clinical trials in adult patients with Manic or Mixed Episodes of Bipolar I Disorder two 3 to 4 week trials and one monotherapy maintenance trial. In adolescent patients with Manic or Mixed Episodes associated with Bipolar I Disorder (ages 13 17), efficacy was established in one 3 week trial [see Clinical Studies ( 14.2 )]. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5 , 5.6 )] . Adjunctive Therapy to Lithium or Valproate Oral ZYPREXA is indicated for the treatment of Manic or Mixed Episodes associated with Bipolar I Disorder as an adjunct to lithium or valproate. Efficacy was established in two 6 week clinical trials in adults. The effectiveness of adjunctive therapy for longer term use has not been systematically evaluated in controlled trials [see Clinical Studies ( 14.2 )] . 1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric Schizophrenia and Bipolar I Disorder are serious mental disorders; however, diagnosis can be challenging. For pediatric Schizophrenia, symptom profiles can be variable, and for Bipolar I Disorder, pediatric patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric Schizophrenia and Bipolar I Disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric Schizophrenia and Bipolar I Disorder should be part of a total treatment program that often includes psychological, educational and social interventions. 1.4 ZYPREXA IntraMuscular: Agitation Associated with Schizophrenia and Bipolar I Mania ZYPREXA IntraMuscular is indicated for the treatment of acute Agitation associated with Schizophrenia and bipolar I Mania. Efficacy was demonstrated in 3 short term (24 hours of IM treatment) placebo controlled trials in agitated adult inpatients with Schizophrenia or Bipolar I Disorder (manic or mixed episodes) [see Clinical Studies ( 14.3 )]. Psychomotor Agitation is defined in DSM IV as excessive motor activity associated with a feeling of inner tension. Patients experiencing Agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the Agitation. 1.5 ZYPREXA and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder Oral ZYPREXA and fluoxetine in combination is indicated for the treatment of depressive episodes associated with Bipolar I Disorder, based on clinical studies in adult patients. When using ZYPREXA and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. ZYPREXA monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. 1.6 ZYPREXA and Fluoxetine in Combination: Treatment Resistant Depression Oral ZYPREXA and fluoxetine in combination is indicated for the treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode), based on clinical studies in adult patients. When using ZYPREXA and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. ZYPREXA monotherapy is not indicated for the treatment of treatment resistant depression. |
Annotated Indication CUIs: C0853193;C0349208;C0338831;C0036341;C0085631;C0853193;C0338831;C0036341; |
RXCUIs for this Label: IN=61381 SCDF=373142; SCD=312077; |
Similar Labels: 3605a8c6-13db-409b-9e5c-19936fef9076; |
Pneumocystis Carinii Pneumonia Sulfamethoxazole and trimethoprim injection USP is indicated in the treatment of Pneumocystis carinii pneumonia in children and adults. Shigellosis Sulfamethoxazole and trimethoprim injection USP is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in children and adults. Urinary Tract Infections Sulfamethoxazole and trimethoprim injection USP is indicated in the treatment of severe or complicated Urinary Tract Infections due to susceptible strains of Escherichia coli , Klebsiella species, Enterobacter species, Morganella morganii and Proteus species when oral administration of sulfamethoxazole and trimethoprim is not feasible and when the organism is not susceptible to single agent antibacterials effective in the urinary tract. Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies. |
Annotated Indication CUIs: C0032305;C0013371;C0042029; |
RXCUIs for this Label: IN=10829 SCDF=377117; SCD=313137; |
Similar Labels: b89b5502-ce87-45a6-a43c-9891da3cfca4; |
1.1 Osteoarthritis (OA) 1.2 Rheumatoid Arthritis (RA) 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course 1 INDICATIONS AND USAGE 1.1 Osteoarthritis (OA) MOBIC is indicated for relief of the signs and symptoms of Osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) MOBIC is indicated for relief of the signs and symptoms of Rheumatoid Arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)]. |
Annotated Indication CUIs: C0553662;C0029408;C0003873; |
RXCUIs for this Label: IN=41493 SCDF=372754; SCD=311486; |
Similar Labels: 36780f92-a17f-4133-8f75-7c3769c40584; |
Colchicine is indicated for prophylaxis of gout flares in adults |
Annotated Indication CUIs: C0018099; |
RXCUIs for this Label: IN=2683 SCDF=371624; SCD=197541; |
Similar Labels: 176af20d-d082-47bd-bc56-a21cc1244a33; |
SECTION For mydriasis and cycloplegia in diagnostic procedures. For some pre and postoperative states when a mydriatic and cycloplegic is needed in treatment of iridocyclitis. |
Annotated Indication CUIs: C0022073; |
RXCUIs for this Label: IN=9601 SCDF=377414; SCD=312910; |
Similar Labels: d7013892-0a00-afd3-cc62-99c195f48c7a; |
For the treatment of intestinal and oral cavity infections caused by Candida (Monilia) albicans. |
Annotated Indication CUIs: C0006849; |
RXCUIs for this Label: IN=7597 SCDF=373136; SCD=312055; |
Similar Labels: 80F2C1BC-D66E-499C-95E0-0FCB17F09CDA; |