BASIC AND CLINICAL STUDIES ON IMIPENEM/CILASTATIN SODIUM IN THE PEDIATRIC FIELD
1986 Volume 39 Issue 7 Pages 1804-1816
Details
1986 Volume 39 Issue 7 Pages 1804-1816
Basic and clinical studies have been performed on imipenem/cilastatin sodium (MK-0787/MK-0791) in the pediatric field.
1. Antibacterial activities of MK-0787 against 14 clinical isolates of S. aureus and 67 isolates of E. coli were determined. The MIC of MK-0787 was 0.10μg/ml or less against all 14 strains of S. aureus. The MIC of MK-0787 was 0.39μg/ml or less against all 67 strains of E. coli.
2. The pharmacokinetics of MK-0787/MK-0791 was studied at dose levels of 10mg/10mg/kg and 20mg/20mg/kg. The peak serum levels of MK-0787 achieved approximately 1 hour after the administration of 10mg/10mg/kg and 20 mg/20mg/kg doses were 38.6μg/ml and 36.2μg/ml, respectively. The serum half-lives were 0.8 hour and 0.9 hour, respectively. The total 6-hour urinary excretions were 82.1% and 66.7%, respectively.
3. The MK-0787/MK-0791 was administered to 13 children with bacterial infections. The clinical results were excellent or good in all cases. The overall efficacy rate was 100%.
4. As a side effect, diarrhea was observed in 1 patient. Abnormalities in laboratory findings observed were elevation of direct bilirubin in 1 patient, thrombocytosis in 2, and a prolonged prothrombin time in 1 patient.
Based on the above results, it can be concluded that MK-0787/MK-0791 is a safe and effective drug to use for the treatment of pediatric infections.
