Abstract
BRL 25000 granules, a formulation consisting of amoxicillin (AMPC) and clavulanic acid (CVA), was evaluated in the field of pediatrics.
In a pharmacokinetic study, serum concentrations were determined in a patient after oral administration of BRL 25000 granules in the non-fasting state at a dose of 11.76mg/kg. The serum levels of amoxicillin (AMPC) and clavulanic acid (CVA) 1 hour after administration were 7.76μg/ml and 6.64μg/ml, with biological half-lives of 0.86 hour and 0.88 hour respectively. The serum concentration profile at a dose of 31.58mg/kg showed almost the same tendency as at 11.76mg/kg, although the peak level and biological half-life of the serum concentrations were not obtained. These serum levels and their peak levels were considered reasonable compared with those obtained in adults at similar dose levels.
In clinical studies, 34 patients were evaluated including 8 patients with acute pharyngitis or acute tonsillitis, 1 patient with acute bronchitis, 1 patient with bronchopneumonia, 23 patients with scarlet fever and 1 patient with pertussis.
BRL 25000 granules were administered orally 3-4 times per day for 4-8 days to 2 patients at doses of 20-30mg/kg/day, to 18 patients at doses of 30-40mg/kg/day, to 11 patients at doses of 40-50mg/kg/day, and to 3 patients at doses of 50-60mg/kg/day. The clinical response was assessed excellent in 13 cases and good in 21 cases giving an overall clinical efficacy rate of 100% (34/34).
The causative organisms were isolated in 17 cases and included 12 strains of Streptococcus group A, 2 S. pneumoniae, 3 H. influenzae and 1 H. parainfluenzae. The clinical response in these 17 patients was excellent in 10 and good in 7. Twelve strains of Streptococcus group A and 2 strains of S. pneumoniae were eradicated after the treatment.
No side effects were observed, although in laboratory findings there was 1 case of slightly elevated GOT and GPT.
