Clinical Evaluation of Rectally Administered Ampicillin in Acute Otitis Media

Abstract

An ampicillin suppository was compared with amoxycillin suspension in the treatment of acute otitis media in children. Both antibiotics were given three times daily for 5 days in a daily dose of 25–50 mg/kg body weight. Safety was evaluated in 454 patients in the group given suppository and in 229 given the suspension, and 421 and 229 patients, respectively, were evaluable for efficacy. Ampicillin was rapidly absorbed and produced plasma concentrations well above the minimum inhibitory concentration for common respiratory pathogens. The overall clinical outcome was satisfactory (cured plus improved) in 89% of the patients given the suppository and in 86% given the suspension. Gastro-intestinal disturbances occurred in 28.4% of the patients given the suppository compared with 14.4% of those given the suspension. Perianal irritation was recorded in 12.1% of the patients given the suppository and in 5.2% of those given the suspension. Treatment was interrupted in 9.8% of patients given the suppository and in 0.9% of those given the suspension. In spite of these discomforts rectally administered ampicillin is considered to be a good alternative in children when oral medication is not feasible.