[Comprehensive evaluation of cefotetan in pediatrics]

Fundamental and clinical studies on cefotetan (CTT), a new cephamycin antibiotic, were carried out under a joint study programme in pediatric field, and the following results were obtained. Pharmacokinetic study In 20 pediatric patients with normal renal function, weighing 15 to 48 kg, CTT was injected intravenously at 20 mg/kg in 3 to 5 minutes. The mean blood concentration of CTT was 215.6 micrograms/ml at 15 minutes after the end of injection, 90.7 micrograms/ml at 1 hour, 57.2 micrograms/ml at 2 hours, 33.9 micrograms/ml at 4 hours and 10.2 micrograms/ml at 8 hours. The half-life of the drug in the beta-phase, computed from the mean blood concentrations up to 8 hours postdosing, was 2.61 hours. The peak of the mean urinary excretion of cefotetan appeared in 0 to 2 hours after the injection and 36.5% of the dose was recovered in the urine. The mean excretion at 0 to 8 hours was 68.1%. Clinical study Clinical effects of CTT was evaluated in 285 patients with 287 diseases, since 1 patient had both pneumonia and erysipelas, and another both pneumonia and acute otitis media. Daily dosage of CTT ranged from 15 to 123 mg/kg, and 266 patients (93.3%) received the drug either 2 or 3 times daily. The clinical response was seen in 83.3% of the 6 cases with sepsis, 89.3% of the 122 cases with pneumonia with or without pyothorax, 96.2% of the 52 cases with either acute bronchitis or tonsillitis, 92.5% of the 67 cases with urinary tract infection and 92.5% of the 40 cases with other infections. The causative organisms were detected in 160 patients and the rate of complete disappearance was 80.6%. Out of 310 patients, side effects were seen in 9 cases, diarrhea in 8 (2.6%) and rash in 1 (0.3%). Abnormal clinical laboratory findings were seen in 24 cases, elevation of serum transaminases in 19 (7.8%), elevation of TTT and LDH in 1 (0.4%) and eosinophilia in 4 (1.6%). None of these cases showed serious side effects or abnormal clinical laboratory findings. From the above results, it is concluded that CTT is one of the useful drug for treatment of infections in pediatric field.