Abstract
Fundamental and clinical studies on BRL 25000 granules, containing 2 parts amoxicillin (AMPC) and 1 part clavulanic acid (CVA)(a β-lactamase inhibitor) were carried out in the pediatric field.
Serum concentrations and urinary excretion rates were determined after oral administration of BRL 25000 granules at a dose of 20mg/kg to 2 children. The mean peak serum concentrations of AMPC and CVA were 4.89 and 2.85μg/ml at 1 hour after administration, with serum half-lives (T 1/2) of 1.15 and 0.89 hours, respectively. Mean cumulative urinary excretion rates of AMPC and CVA in the 6 hours after administration were 24.91% and 10.19%, respectively.
BRL 25000 granules were also administered at daily doses of 25.1-60.4mg/kg in 3 divided doses, to 20 pediatric patients with bacterial infections (4 acute tonsillitis, 2 acute pharyngitis, 3 suspected scarlet fever, 3 acute bronchitis, 8 urinary tract infection). The efficacy rate was 100% clinically and 70% bacteriologically.
No adverse reactions were observed, however, abnormal laboratory findings were observed in 4 cases (slight elevation of GOT in 2, GPT in 1, eosinophilia in 1).
