The overall safety of oral roxithromycin in paediatric clinical studies

Abstract

In two multicentre, non-comparative studies, a total of 477 children, aged 2 months to 15 years, suffering from respiratory tract infections or skin and soft tissue infections were treated with roxithromycin (50 mg sachets). The mean duration of treatment was 9 days and the mean daily dose was 6 mg/kg/day administered b.i.d. The overall safety of roxithromycin was assessed by analysing the adverse events reported by the patients or investigators, the discontinuation of treatment because of adverse events, and the laboratory data. Adverse events reported by 20 (4%) children were considered to be possibly drug related. These adverse events were mainly digestive in nature and mild or moderate in severity. Treatment was discontinued because of adverse events in six (1%) children. Analysis of laboratory data revealed a few variations without any clinical significance.