Ampicillin Pharmacokinetics and Safety in Infants
Book Chapter
Authors:
Benjamin, D. K., Jr.;
Lewandowski, A.;
Anand, R.
Secondary:
Best Pharmaceuticals for Children Act (BPCA) Clinical Reports
Location: Bethesda, MD
PMID:
34606189
URL:
https://www.ncbi.nlm.nih.gov/pubmed/34606189
Keywords:
pharmacokinetics (PK) infants ampicillin
Abstract:
Aim: NICHD-2012-AMP01 study was designed to characterize the pharmacokinetics (PK) and safety of ampicillin administered to infants per standard of care to address gap in pediatric labeling. Methods: The PK analysis include ampicillin data from NICHD-2011-POP01 study. The safety analysis includes ampicillin data from 1) NICHD-2011-POP01 study 2) Pediatric Pharmacology Research Unit (PPRU) study and 3) Pediatrix Medical Group Database. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. From the Pediatrix database Adverse events during ampicillin exposure were uncommon. Shorter dosing intervals were associated with more frequent hematologic AEs for infants of all age groups.
