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Safety and tolerability of clarithromycin administered to children at higher-than-recommended doses

D A Kafetzis1, F Chantzi, G Tigani

  • 1Second Department of Pediatrics, University of Athens, P. & A. Kyriakou Children's Hospital, Thivon & Levadeias St., Athens, 115 27, Greece. kafetzis@ath.forthnet.gr

European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology
|January 12, 2007
PubMed

Insights

Pediatricians often prescribed higher clarithromycin doses than recommended. This study found higher clarithromycin doses were safe and well-tolerated in children with common respiratory infections.

Area of Science:

  • Pediatric Infectious Diseases
  • Pharmacology
  • Clinical Therapeutics

Background:

  • A trend of using higher-than-recommended clarithromycin doses in Greek pediatric practice was observed.
  • This macrolide antibiotic is frequently prescribed for pediatric respiratory infections.

Purpose of the Study:

  • To evaluate the safety and tolerability of clarithromycin in children, particularly when administered at doses exceeding recommendations.
  • To compare outcomes between children receiving recommended versus higher clarithromycin doses.

Main Methods:

  • A 9-month observational study involving 343 nonhospitalized children treated by 29 pediatricians in Athens.
  • Patients received clarithromycin for upper or lower respiratory tract infections, with dosage data meticulously recorded.
  • Tolerability and adverse events were systematically assessed and compared between dosage groups.

Main Results:

  • Over 77% of children received clarithromycin doses exceeding the recommended 15 mg/kg/day.
  • Clarithromycin demonstrated good to very good tolerability in over 96% of cases, with only 4% experiencing intolerability.
  • No statistically significant differences in tolerability or adverse events were found between recommended and higher dose groups.

Conclusions:

  • Clarithromycin exhibits a safe and well-tolerated profile in pediatric patients with common infections, even at doses above standard recommendations.
  • The efficacy of higher clarithromycin doses in pediatric respiratory infections warrants further investigation.

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