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Laboratory and clinical studies on BRL 25000 (clavulanic acid -amoxicillin) granules in the pediatric field



Laboratory and clinical studies on BRL 25000 (clavulanic acid -amoxicillin) granules in the pediatric field



Japanese Journal of Antibiotics 38(2): 253-262



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 wt, the maximum serum levels of AMPC and CVA achieved .apprx. 1 h after dosing were 8.68 .mu.g/ml and 4.09 .mu.g/ml, and declined thereafter with half-lives of 1.39 and 0.80 h, respectively. The 6 h 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 wt, the serum levels of AMPC and CVA peaked at 7.37 .mu.g/ml and 2.98 .mu.g/ml after 1 h, and declined with half-lives of 2.52 and 0.99 h, respectively. The 6 h 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. [Staphylococcus aureus, S. epidermidis, Streptococcus pyogenes, S. pneumoniae, Group A .beta., Escherichia coli, Haemophilus influenzae, H. parainfluenzae, Klebsiella pneumoniae, Enterobacter cloacae and Morganella morganii]. 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.

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Accession: 005787338

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PMID: 4009947


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