Efficacy and safety of cefpodoxime in the treatment of acute otitis media in children

Abstract

BackgroundAcute otitis media (AOM) is a community-acquired respiratory tract infection in childhood frequently encountered by primary-care physicians and can cause a significant morbidity. Increasing bacterial resistance has led to concern about the current options for empirical antibiotic treatment and has prompted a search for effective treatments. ObjectivesTo evaluate the clinical efficacy and safety of cefpodoxime proxetil in the treatment of children with acute otitis media. Patients and methodsA prospective, multicenter study was conducted on 1380 children aged from 1 to 13years with AOM who were prescribed a 5–10day course of cefpodoxime proxetil (8mg/kg/day). Patients were followed-up after 7–14days from baseline visit. Efficacy was assessed by the percentage of patients with clinical cure, improvement or failure at the follow-up visit. Safety was evaluated by recording the occurrence and severity of any adverse events and by the physicians’ and patients’ assessment of overall tolerability. ResultsClinically, 82.5% of patients were cured, 16.4% improved and there was failure of therapy in 1.1% of the patients. The overall combined cure and improvement rate of all related signs and symptoms was 98.9%. Adverse events, diarrhea and skin rash, were reported by only 16 patients (1.2%). The overall tolerability according to the physicians’ and patients’ assessment was excellent in 93.9% and 88.9%, respectively. Compliance was attained in 99.5% of patients. ConclusionCefpodoxime proxetil is an effective, safe, well-tolerated antimicrobial agent for treatment of acute otitis media in children. It can be considered as an excellent choice for the empirical treatment of bacterial AOM.