Paediatric Dosing Information in Package Insert of Antibiotics Used in a Malaysian Tertiary Hospital

Introduction Paediatric patients are commonly prescribed with antibiotics and most of it lacks adequate dosing information. This study was conducted to determine the nature and extent of paediatric dosing information available in package inserts (PIs) of antibiotics.

Methodology In this cross-sectional study, the PIs of antibiotics available in the hospital were collected and reviewed. Antibiotics with PIs in foreign language or prepared extemporaneously in the hospital were excluded. These PIs were reviewed for dosing information in paediatric patients according to paediatric age classification, using a validated categorisation system.

Results  A total of 156 PIs were reviewed involving 80 types of antibiotics. In total, 80.8% of the PIs reviewed provided inadequate paediatric dosing information for all age groups. The proportion of PI with adequate dosing information increased consistently with age group (neonates: 19.9%, infants: 37.2%, children: 48.1% and adolescents: 52.6%). It was also found that 11.5%, 8.3%, 3.8%, and 1.9% of PIs contraindicated the use of antibiotics in neonates, infants, children and adolescents, respectively. Averagely, about 20% of the PIs did not contain dosing information for paediatric use.   

Discussion / Conclusion The majority of PI for antibiotics reviewed did not provide adequate dosing information for paediatric patients. This could lead to many antibiotics to be used outside the marketing authorisation or at suboptimal dose. In the absence of authorised dosing information, evidence from clinical practice on safety and effectiveness of antibiotics should be documented in a structured manner to support rationale and optimal use of antibiotics in children.

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