THE OVERALL SAFETY OF ORAL ROXITHROMYCIN IN PEDIATRIC CLINICAL-STUDIES

In two multicentre, non-comparative studies, a fetal of 477 children, aged 2 months to 15 years, suffering from respiratory tract infections or skin and soft tissue infections were treated with roxithromycin (5 0 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 r oxithromycin was assessed by analysing the adverse events reported by the patients or investigators, the discontinuation of treatment becaus e 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 i n severity. Treatment was discontinued because of adverse events in si x (1%) children. Analysis of laboratory data revealed a few variations without any clinical significance.