FUNDAMENTAL AND CLINICAL STUDIES OF CEFMINOX IN CHILDREN

Abstract

Cefminox (CMNX, MT-141), a newly developed injectable cephem antibiotic, was administered intravenously as one shot injection at 3 different dosages of 10, 20 and 40mg/kg to 9 children; for each dose level 3 children were used. In these children serum and urinary concentrations as well as recovery rates were determined. In addition, in order to determine clinical and bacteriological efficacies of CMNX, it was used in the treatment of 37 cases of various infections consisting of 2 cases of acute tonsillitis, 1 case of acute tonsillitis associated with otitis media, 1 case of acute bronchitis, 1 case of chronic bronchitis, 20 cases of pneumonia, 1 case of pneumonia associated with otitis media, 8 cases of urinary tract infections, 2 cases of purulent lymphadenitis and 1 case of gluteal abscess. The drug was administered intravenously as one shot injection at a mean daily dosage of 76.6mg/kg, in 4 divided doses in most cases, for a mean period of 6 days. Finally, in 43 cases added of 6 drop out cases which were included in analysis of efficacy side effects and abnormal laboratory findings were examined. The following results were obtained.
1. In 9 cases, which received CMNX at 3 different dosages of 10, 20 and 40mg/kg for 3 cases each intravenously as one shot injection, mean serum concentrations reached the peaks of 109.4, 218.1 and 357.1mcg/ml at 5 minutes after injection, respectively, showing dose response relation. The mean half-lives were 1.74, 1.62 and 1.84 hours, respectively.
2. The mean concentrations of CMNX in urine in the same cases as used for determinations of serum concentrations were highest during the 0-2 hours period, reaching 1,582, 3,304 and 4,618mcg/ml at the respective doses. The mean recoveries within the first 6 hours were 82.8, 69.8 and 81.3%, the rate for 20mg/kg group being lower than those obtained for the other groups. This is possibly due to 1 case which showed unusually low recovery rate of 44.4%. When this case is excluded, the recovery rates became similar for all groups.
3. As to clinical results, responses rated as good or higher were obtained for 91.9% of the cases (34 cases/37 cases), with high efficacy rate.
4. No side effects were seen in 43 cases included of drop out cases. Laboratory findings revealed eosinophilia in 6 cases and abnormal elevation of GPT alone in 1 case, of GOT and GPT simultaneously in 1 case and of creatinine in 1 case.