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

A tendency among pediatricians in Greece to use higher-than-recommended doses of clarithromycin was noted over several years, prompting this study of the safety and tolerability of this macrolide in 343 children over a period of 9 months. The study group comprised nonhospitalized patients of 29 pediatricians practicing in Athens. All were prescribed clarithromycin for upper respiratory (n = 257) or lower respiratory tract infection (n = 78). Overall, 77.8% were treated with doses that exceeded the recommended dose of 15 mg/kg/day, and 26% received doses of > or = 30 mg/kg/day (median dose, 20 mg/kg/day). The tolerability of clarithromycin was judged as "very good" in 75% of the children, as "good" in 16%, and as "moderate" in 5%, whereas intolerability was observed in 4% of the cases. Adverse reactions, mainly gastrointestinal in nature, were reported in 17.5% of the cases. With regard to both tolerability and adverse events recorded, there were no statistically significant differences between the group of patients who received the recommended dose and the group who received higher doses. Clarithromycin continues to present a safe and well-tolerated profile for the treatment of common pediatric infections, even when administered at higher-than-recommended doses. Whether it is more efficacious in this setting is a matter for further study.