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Pharmacokinetics of a clarithromycin suspension in infants and children

V N Gan1, S Y Chu, H T Kusmiesz

  • 1Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas 75235-9063.

Antimicrobial Agents and Chemotherapy
|November 1, 1992
PubMed

Insights

Clarithromycin absorption in children is rapid and unaffected by food. Studies show no significant accumulation of the drug or its metabolite with multiple doses, indicating predictable pediatric dosing.

Area of Science:

  • Pediatric Pharmacology
  • Drug Metabolism and Pharmacokinetics
  • Antibiotic Therapy

Background:

  • Clarithromycin is a widely used antibiotic in pediatric populations.
  • Understanding its pharmacokinetic profile in children is crucial for safe and effective dosing.
  • Limited data exist on clarithromycin pharmacokinetics in infants and children, particularly regarding food effects.

Purpose of the Study:

  • To investigate the single- and multiple-dose pharmacokinetics of clarithromycin and its metabolite in pediatric patients.
  • To evaluate the impact of fasting versus nonfasting conditions on clarithromycin absorption and disposition.
  • To assess potential drug accumulation with repeated dosing in children.

Main Methods:

  • Oral administration of clarithromycin in single and multiple doses to infants and children.
  • Plasma concentrations of clarithromycin and its 14-(R)-hydroxylated metabolite were measured.
  • Pharmacokinetic parameters, including Cmax and AUC, were analyzed under fasting and nonfasting conditions.

Main Results:

  • Rapid drug absorption observed, with peak plasma concentrations (Cmax) reached around 3 hours post-dose.
  • Mean Cmax for clarithromycin and its metabolite showed minimal variation between fasting and nonfasting states.
  • No significant food effect on absorption was detected; no unusual accumulation of drug or metabolite occurred with multiple dosing.

Conclusions:

  • Clarithromycin demonstrates predictable oral absorption in pediatric patients, irrespective of food intake.
  • The pharmacokinetic profile suggests that food does not significantly alter clarithromycin bioavailability in children.
  • The absence of drug accumulation supports established dosing regimens for clarithromycin in pediatric populations.

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