[Pharmacokinetic and clinical studies of sultamicillin fine granules in children]

Sultamicillin (SBTPC) is a semi-synthesized beta-lactam antibiotic consisted of ampicillin (ABPC) and a beta-lactamase inhibitor, sulbactam (SBT), linked with an ester linkage. Pharmacokinetic and clinical studies using SBTPC 10% fine granules were performed in pediatric patients with a variety of infections. 1. Pharmacokinetic investigation: SBTPC was given at 30 minutes after meal at a dose of 10 mg/kg. Peak serum levels were attained at 1 hour after dosing with average levels of 3.83 +/- 0.27 micrograms/ml for ABPC and 2.73 +/- 0.30 micrograms/ml for SBT. The average half-life of ABPC was 1.52 +/- 0.25 hours and that of SBT was 1.13 +/- 0.09 hours. The urinary recovery rate of ABPC during 6 hours after dosing was 58.2 +/- 4.9% and that of SBT was 59.7 +/- 6.4%. 2. Clinical investigation: Enrolled in the study were a total of 26 patients including 12 with tonsillitis, 6 with pharyngitis, 5 with urinary tract infections, and 1 each with bronchitis, with Salmonella enteritis and a case with fever of unknown case. Responses were excellent in 15 patients, good in 8, fair in 2 and poor in 1 with an efficacy rate of 88.5%. In the assessment of the bacteriological efficacy, 11 out of 14 strains of organisms isolated previous to the treatment were eradicated, 1 strain was found reduced in number and 2 strains remained unchanged with an eradication rate of 78.6%. One patient (3.8%) out of the 26 had diarrhea as side effects and 3 patients (16.7%) of 18 showed eosinophilia in laboratory examinations.