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A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii
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Population Pharmacokinetics and Dosing Optimization of Amoxicillin in Chinese Infants

Yue-E Wu1, Ya-Kun Wang2, Bo-Hao Tang1

  • 1Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, China.

Journal of Clinical Pharmacology
|September 30, 2020
PubMed

Insights

This study found current amoxicillin dosing for infants is suboptimal. A higher dose (60 mg/kg thrice daily) significantly improves treatment effectiveness for bacterial infections in infants.

Area of Science:

  • Pediatric Pharmacology
  • Infectious Diseases
  • Pharmacokinetics

Background:

  • Amoxicillin is a common antibiotic for infant bacterial infections.
  • Current dosing lacks robust pharmacokinetic data, leading to variable clinical practices.
  • Infant dosing regimens require optimization for improved therapeutic outcomes.

Purpose of the Study:

  • To evaluate the population pharmacokinetics of intravenous amoxicillin in infants.
  • To determine an optimal dosage regimen for amoxicillin in this population.
  • To assess the impact of weight-based dosing on achieving therapeutic targets.

Main Methods:

  • Opportunistic blood sampling for amoxicillin concentration determination.
  • High-performance liquid chromatography (HPLC) for plasma concentration analysis.
  • Non-linear mixed-effects modeling (NONMEM) for population pharmacokinetic analysis.

Main Results:

  • A two-compartment model with first-order elimination best described amoxicillin pharmacokinetics.
  • Infant body weight was identified as the sole significant covariate.
  • Current dosing (25 mg/kg twice daily) achieved pharmacodynamic targets in only 22.4% of infants.
  • Recommended dosing (60 mg/kg thrice daily) increased target attainment to 80.9%.

Conclusions:

  • Current amoxicillin dosing regimens in infants are inadequate for achieving therapeutic targets.
  • A revised regimen of 60 mg/kg thrice daily is recommended for improved efficacy.
  • Antibiotic choice should be reconsidered for infections with high amoxicillin MICs, such as Escherichia coli.

Keywords:
amoxicillinbacterial infectionsdosing optimizationinfantspopulation pharmacokinetics

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