[Studies on S-1108 in pediatric infection]

Pharmacokinetic and clinical studies on S-1108, a new oral cephem antibiotic, were performed in pediatric infections and the following results were obtained. 1. Pharmacokinetics studies Pharmacokinetics of S-1108 was studied in 4 children (3 y 7 m-11 y 1 m) using doses of 2 mg/kg (n = 2) and 4 mg/kg (n = 2). The average peak plasma level was 0.88 microgram/ml at 2 hours after administration of 2 mg/kg and 2.00 micrograms/ml at 3 hours after administration of 4 mg/kg, and plasma half-lives were 1.45 and 0.96 hours, respectively. Average cumulative urinary recovery rates at 0-6 hours were 30.0 and 34.8%, respectively. 2. Clinical studies S-1108 was administered to 32 patients with various infectious diseases (6 with acute tonsillitis, 2 each with pertussis and acute bronchitis, 3 with pneumonia, 4 with scarlet fever, 5 with impetigo contagiosa, 6 with acute urinary infection and 1 each with subcutaneous abscess, impetigo, vulvitis and urethritis) at daily doses between 6-12 mg/kg/day, t.i.d., for 5-12 days. Clinical responses were excellent in 17 patients, good in 13, and poor in 2, and the efficacy rate was 93.8%. Bacteria were identified and 33 strains of 12 species were found. The eradication rate was 93.9%. No side effects were observed in 43 patients. Abnormal laboratory test values were observed in 2 patients, 1 with elevation of eosin. and the other with elevations of GOT and GPT. The results suggest that S-1108 may be a very useful and safe drug for the treatment of pediatric infections.