[Experimental and clinical studies on BRL 25000 (clavulanic acid-amoxicillin) granules in the pediatric field].
Fundamental and clinical studies on BRL 25000 granules, containing 2 parts amoxicillin (AMPC) and 1 part clavulanic acid (CVA) (a beta-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 20 mg/kg to 2 children. The mean peak serum concentrations of AMPC and CVA were 4.89 and 2.85 micrograms/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 25.1-60.4 mg/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).
D000284:Administration, Oral; D000367:Age Factors; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D004304:Dosage Forms; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006207:Half-Life; D006801:Humans; D007223:Infant; D008297:Male
D000900:Anti-Bacterial Agents; D002969:Clavulanic Acids; D004304:Dosage Forms; D004338:Drug Combinations; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin