LABORATORY AND CLINICAL STUDIES ON CEFDINIR IN PEDIATRIC FIELD

Pharmacokinetic and clinical studies on cefdinir (CFDN) capsule and fine granules in children were performed and the following results were obtained. 1. Plasma level and urinary excretion of CFDN were determined in 10 children with ages 7 to 13 years given single doses of 2.3 to 7.5 mg/kg. Six of the 10 children received the drug orally before meal and the other 4 after meal. Plasma concentration peaked at 2 to 4 hours in the children administered the drug before meal, and at 3 to 4 hours in those given the drug after meal. The 8-hour urinary recovery rate was 18.8%. 2. Clinical efficacies were evaluated in 23 children with bacterial infections. The children were given the drug orally at dose levels of 3.3 to 6.3 mg/kg 3 times a day. Clinical effects of CFDN were excellent in 7 and good in others, hence the overall clinical efficacy rate was 100%. 3. Bacteriologically, 18 of the 19 strains of causative organisms identified were eradicated, with an overall bacteriological eradication rate of 94.7%. 4. As for side effects, loose stool was observed in 1 case, but it disappeared in a few days. In laboratory tests a slight elevation of GOT and GPT were observed in 1 case, but no additional treatment was needed. 5. CFDN is a useful oral antibiotic for the treatment of bacterial infections in pediatric field.