[Pharmacokinetical, bacteriological and clinical studies of flomoxef in the pediatric field]

Pharmacokinetical, bacteriological and clinical studies of flomoxef (FMOX, 6315-S), a new cephem antibiotic, were conducted in the pediatric field. 1. Mean drug concentrations in the blood after intravenous one shot injection of FMOX 20 mg/kg to 5 children (aged 5-8 years) were 39.7 micrograms/ml at 1/4 hour, 24.1 micrograms/ml at 1/2 hour, 12.2 micrograms/ml at 1 hour, 4.7 micrograms/ml at 2 hours, 1.1 microgram/ml at 4 hours, and 0.3 microgram/ml at 6 hours. The mean half-life in blood was 0.65 hour. Mean concentrations in urine was 3,558 micrograms/ml during 0-2 hours after intravenous injection, 568 micrograms/ml during 2-4 hours, and 117 micrograms/ml during 4-6 hours. The mean 6-hour urinary recovery rate was 72.8%. 2. Clinically, FMOX was administered to 32 children (5 months to 9 years) with infections, i.e. 29 with pneumonia, 1 each with acute purulent tonsillitis, acute purulent lymphadenitis and cellulitis. The treatment was excellent in 24 cases and good in 8. Thus, the efficacy rate was 100%. 3. The bacteriological effect of FMOX was investigated using 11 clinical isolates which were considered to be causative organisms, i.e. 1 strain of Staphylococcus aureus, 1 strain of Streptococcus pneumoniae, 8 strains of Haemophilus influenzae and 1 strain of Haemophilus parainfluenzae. Except one strain (H. influenzae) which was just decreased, all the bacteria were eliminated. 4. No side effect was found at all. As abnormal laboratory findings, elevation of GOT was found in 1 case, thrombocytosis in 2, and eosinophilia in 1 but all the changes were slight and were normalized by the time of re-examination. The above results suggest that FMOX is a useful and safe drug for the pediatric practice just as in the adult field.