Clinical studies of flomoxef in the pediatric field

Flomoxef (FMOX, 6315-S) was evaluated pharmacologically and clinically in its application to bacterial infections in children. 1. Pharmacokinetics: A bullous intravenous injection of FMOX at 20 mg/kg body weight gave a peak serum concentration of 114.6 +/- 34.4 micrograms/ml in 1 minute after the injection and T1/2 of beta-phase was 0.86 +/- 0.15 hours. 2. Bacteriological effectiveness: MIC of FMOX against Staphylococcus aureus except resistant strains (10(6) cells/ml) was below 0.39 micrograms/ml and against Haemophilus influenzae, Escherichia coli and Klebsiella pneumoniae (10(6) cells/ml) were below 0.78 microgram/ml. 3. Clinical effectiveness: Clinical effectiveness of FMOX was excellent in 14 cases, good in 2 cases and fairly good in 1 case among 17 cases of bacterial infections examined. An increase in eosinophilic leukocytes was observed in 1 case but no other clinical adverse effects were detected. These findings indicate that FMOX is a useful and safe antibiotic as a first choice against bacterial infections in children.