[Clinical study of BRL 25000 (clavulanic acid-amoxicillin) granules in pediatric infections].

BRL 25000 granules, a formulation of amoxicillin (AMPC) and the beta-lactamase inhibitor clavulanic acid (CVA) in a ratio of 2 to 1, was studied clinically and bacteriologically in pediatric infections. The in vitro antibacterial activity of BRL 25000 was superior to AMPC against beta-lactamase producing strains. The pharmacokinetics of the BRL 25000 granule were studied following oral administration to a 6 years old female and 9 years old male in the fasting state at dose levels of 10 mg/kg and 16.1 mg/kg, respectively. In the case of the female dosed at 10 mg/kg, the peak serum concentrations were found to be 6.38 micrograms/ml for AMPC and 1.83 micrograms/ml for CVA at 1 hour following administration. The elimination half-life of AMPC was 0.86 hour and that of CVA was 0.67 hour. The 4-hour urinary recovery was 61.89% for AMPC and 17.92% for CVA. In the male receiving 16.1 mg/kg, the peak concentrations were 2.55 micrograms/ml for AMPC at 3 hours following administration and 1.46 micrograms/ml for CVA at 1.5 hours following administration. The elimination half-life of AMPC was 1.59 hours and that of CVA was 1.19 hours. The 6-hour urinary recovery was 44.19% for AMPC and 30.05% for CVA. In clinical studies, the BRL 25000 granule was administered to 36 infants with upper respiratory tract infections, mainly tonsillitis, urinary tract infections etc. Good clinical efficacy was obtained in 33/36 cases (91.7%). Diarrhea and rash were occasionally noted side effects but were not severe. From the above results, it can be concluded that the BRL 25000 granule is a suitable and effective drug for use in the treatment of pediatric infections.