OVERVIEW OF THE SAFETY PROFILE OF CLARITHROMYCIN SUSPENSION IN PEDIATRIC-PATIENTS

Results of preclinical studies conducted to characterize the safety of clarithromycin oral suspension in juvenile mice, rats and dogs as com pared with that in adult animals indicate that there is no enhanced ri sk in younger animals. Adverse events in these preclinical studies mai nly involved decreased body and increased liver and kidney weights. Th e safety profile of clarithromycin suspension also has been evaluated in Phase II (pharmacokinetic) and III (clinical) United States and int ernational clinical trials conducted in pediatric patients. The most f requently reported adverse events occurring among the 1676 patients st udied who received clarithromycin suspension in Phase m trials include d diarrhea (7%), vomiting (6%), abdominal pain (2%), headache (2%) and nausea (1%). Adverse events were not serious and were usually rapidly reversible. Adverse event rates did not vary with sex or race. Overal l adverse event rates were generally similar to those of comparator be ta-lactam suspensions (i.e. amoxicillin, amoxicillin/clavulanate, peni cillin VK, cefaclor, cefadroxil). With regard to specific gastrointest inal events, however, clarithromycin was better tolerated than amoxici llin/clavulanate whereas penicillin VK showed a lower incidence of gas trointestinal events. Overall clarithromycin oral suspension appears t o be safe and well-tolerated, making it suitable for use in the pediat ric population.