Efficacy and tolerability of cefixime in otitis media. A multicentre study in over 25,000 children.

A large scale multicentre clinical study was undertaken to assess the efficacy and tolerability of cefixime in the treatment of acute otitis media in children. A total of 25,863 evaluable children with acute otitis media received cefixime 8 mg/kg once daily for at least 10 days. At the end of treatment, 86% of patients were considered to be either cured or improved. These results are consistent with those achieved with cefixime in controlled clinical trials. Adverse effects were reported in 11.5% of patients, but were judged to be related to cefixime therapy in only 9.4% of patients. The results of this study demonstrate that cefixime is an effective and well tolerated treatment for acute otitis media in children.