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Published on: January 2, 2017

Pharmacokinetics of intravenously administered azithromycin in pediatric patients

Richard F Jacobs1, Holly D Maples, Jacob V Aranda

  • 1Division of Pediatric Infectious Disease, Arkansas Children's Hospital, 800 Marshall Street, Little Rock, AR 72202, USA. jacobsrichardf@uams.edu

The Pediatric Infectious Disease Journal
|January 25, 2005
PubMed

Insights

This study found that intravenous azithromycin (AZM) has comparable pharmacokinetics and is well-tolerated in children aged 0.5 to 16 years. These findings support its use in pediatric therapeutic trials.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Drug Development

Background:

  • Azithromycin is a widely used antibiotic.
  • Limited pharmacokinetic data exists for intravenous azithromycin in pediatric populations.
  • Understanding drug disposition in children is crucial for safe and effective dosing.

Purpose of the Study:

  • To characterize the pharmacokinetics of a single intravenous azithromycin dose in children.
  • To assess the tolerance and safety of intravenous azithromycin in pediatric patients.
  • To provide data for future azithromycin dosing strategies in children.

Main Methods:

  • Stratified pediatric subjects into four age groups (0.5-16 years).
  • Administered a single 10 mg/kg intravenous dose of azithromycin (maximum 500 mg).
  • Collected serial blood samples for 168 hours and performed safety evaluations.
  • Quantified serum azithromycin concentrations using HPLC-MS and calculated pharmacokinetic indices.

Main Results:

  • Thirty-two children participated, with mean age 6.7 years.
  • Pharmacokinetic parameters (AUC0-72, Cmax, t1/2) were comparable across all age groups.
  • No significant association between age and azithromycin exposure (AUC0-72, Cmax).
  • The azithromycin dose was well-tolerated with no serious adverse events reported.

Conclusions:

  • Intravenous azithromycin disposition is similar in pediatric patients aged 0.5 to 16 years.
  • The established dosing regimen is safe and predictable in this pediatric population.
  • These pharmacokinetic data can inform dose selection for future pediatric IV azithromycin trials.
Abstract

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