Pregnancy and Lactation
- 1. Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, BG Nagara, India.
Description
Pregnancy and breastfeeding are distinct physiological states associated with major changes in the concentration and effectiveness of medications; however, literature is lacking regarding medication use in both of these special populations. This chapter outlines the principles of clinical pharmacology necessary to improve medication usage during pregnancy and postpartum. Physiological changes that occur in pregnancy (including increased blood volume, altered protein binding, increased hepatic clearance through CYP3A4/CYP2D6 and UGT1A4, increased renal clearance) may also affect absorption, distribution, metabolism and excretion of drugs at different time points in pregnancy. Considerations of lactation pharmacology are also reviewed by discussing the physiochemical properties of drugs that can affect transfer into milk and calculating infant drug exposure. Additionally, we reviewed the progress made with regard to product labeling due to the evolution from FDA’s five-letter pregnancy risk categories (A-X) to today's Pregnancy and Lactation Labeling Rules (PLLR) and a narrative-based approach on risk evaluation. Special populations (including pregnant women with seizures, depression, anxiety or heart disease) are also included through case study-based discussions about use of lamotrigine during pregnancy (which can require as much as an additional 2.7 times the amount of medicine compared to non-pregnancy) and postpartum dose titration strategies.
Emerging methodologies, including physiologically based pharmacokinetic (PBPK) modeling and pharmacogenomic considerations, are presented as tools to advance precision pharmacotherapy. The chapter concludes with practical algorithms for clinical decision-making and highlights priority areas for future research.
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Chapter-7.pdf
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Additional details
Dates
- Submitted
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2025-11-18
- Accepted
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2026-03-15
References
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