Neonatal Pharmacology

The key feature of neonatal physiology is fast maturation, resulting in extensive variability in pharmacokinetics and -dynamics, further aggravated by other covariates, like pharmacogenetics or unique disease characteristics. Consequently, between and intra-individual variability is the essence of neonatal care and neonatal pharmacology. The principles of neonatal therapeutics are discussed, with emphasis on maturational pharmacokinetics (absorption, distribution, metabolism, elimination). Thorough understanding of these factors, especially developmental changes, that affect pharmacokinetics in neonates helps to provide accurate dose adjustments to prescribe effective drug therapy. General aspects of pharmacokinetic principles are discussed, and subsequently applied to commonly administered drugs in neonates. Adverse drug events are frequent and important aspects of neonatal drug therapy. Pharmacovigilance is based on prevention, detection, and assessment, but all these issues need to be adapted to the specific characteristics of this population. Minimization or prevention of such events can be achieved and are discussed. Drug excretion in breast milk and guidance on how to retrieve relevant information is provided, as this is an important and emerging part of neonatal pharmacology. Finally, neonatal drug development tailored to and driven by neonatal (patho)physiology is urgently needed to further improve neonatal pharmacotherapy.