Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia

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The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N = 125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3,000 g, 2 days PNA (i.e., TEMP 33.5°C), and normal UO, Cl was 0.26 L/h (interindividual variability (IIV) 41.9%) and volume of distribution of the central compartment was 0.34 L/kg (IIV of 114.6%). For this patient, Cl increased to 0.41 L/h at PNA 5 days and TEMP 37.0°C. The respective contributions of both covariates were 23% and 27%. Based on Monte Carlo simulations we recommend 50 and 75 mg/kg/24h amoxicillin in three doses for patients with GA 36–37 and 38–42 weeks, respectively.

Original languageEnglish
Pages (from-to)458-467
Number of pages10
JournalClinical Pharmacology & Therapeutics
Issue number3
Publication statusPublished - Mar 2018


  • Aging/metabolism
  • Algorithms
  • Amoxicillin/administration & dosage
  • Anti-Bacterial Agents/administration & dosage
  • Birth Weight
  • Body Temperature
  • Cohort Studies
  • Computer Simulation
  • Female
  • Gestational Age
  • Humans
  • Hypothermia/metabolism
  • Infant, Newborn
  • Male
  • Monte Carlo Method
  • Prospective Studies
  • Urodynamics


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