SAFETY PROFILE OF CEFIXIME - RESULTS OF A GERMAN POSTMARKETING SURVEILLANCE STUDY OF 6361 PATIENTS

The safety profile of cefixime was evaluated in 6361 adult and pediatr ic patients with mostly respiratory tract infections; urinary tract in fections; and ear, nose, and throat infections. The daily dose of cefi xime was 400 mg in adults and 8 mg/kg body weight in children. Cefixim e was administered once daily in 62.4% of patients and twice daily in 36.3% of patients. In 57 patients (0.9%) the dosage regimen changed du ring therapy and in 28 patients (0.4%) no information on dosage was av ailable. Cefixime was administered as tablets or suspension. Adverse e vents were experienced in 493 (7.8%) of 6361 patients; 477 of the 610 adverse events were gastrointestinal in nature. In 236 (7.4%) of the 3 194 patients treated with tablets, 309 adverse events were reported, c ompared with 295 adverse events in 253 (8.06%) of 3138 patients treate d with oral suspension form. Of the 610 adverse events reported, 292 ( 47.9%) were classified as at least moderately severe and at least poss ibly related to cefixime. Seventy-three (12.0%) of the reported advers e events were assessed as severe. Thirty-three patients discontinued t he study prematurely. Once-daily administration of cefixime was at lea st safe as twice-daily administration. The results of this postmarketi ng surveillance study demonstrate that cefixime is well tolerated in d aily practice.