[Laboratory and clinical studies on BRL 25000 (clavulanic acid -amoxicillin) granules in the pediatric field].
Laboratory and clinical studies on BRL 25000 granules (containing clavulanic acid (CVA) 1 part plus amoxicillin (AMPC) 2 parts) were performed in infections in the pediatric field. Following oral administration of BRL 25000 granules at a dose of 15 mg/kg body weight, the maximum serum levels of AMPC and CVA achieved approximately 1 hour after dosing were 8.68 micrograms/ml and 4.09 micrograms/ml and declined thereafter with half-lives of 1.39 and 0.80 hours, respectively. The 6-hour urinary recovery rates for AMPC and CVA were 55.81% and 26.08%, respectively. Following oral administration of BRL 25000 granules at a dose of 22.5 and 24.3 mg/kg body weight, the serum levels of AMPC and CVA peaked at 7.37 micrograms/ml and 2.98 micrograms/ml after 1 hour and declined with half-lives of 2.52 and 0.99 hours, respectively. The 6-hour urinary recovery rates for AMPC and CVA were 40.02% and 13.95%, respectively. The clinical efficacy of BRL 25000 granules was evaluated in 23 patients with upper respiratory tract infections, skin infections, etc. Overall the clinical efficacy was good to excellent in 21/23 (91.3%). The bacteriological and clinical efficacy rates for beta-lactamase producing bacteria and non-producing bacteria were 50% (1/2) and 100% (12/12), respectively. Side effects were observed in 1 patient, who experienced mild diarrhea and abdominal pain but not of a severe nature.
D000284:Administration, Oral; D000367:Age Factors; D000658:Amoxicillin / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use*; D004304:Dosage Forms; D004338:Drug Combinations / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007223:Infant; D007700:Kinetics; D008297:Male
D000900:Anti-Bacterial Agents; D002969:Clavulanic Acids; D004304:Dosage Forms; D004338:Drug Combinations; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin