[Clinical investigation of cefdinir in the pediatric field]

We performed pharmacokinetic, bacteriological and clinical studies on cefdinir granules (CFDN, FK482), and obtained the results summarized below. 1. Serum levels of CFDN when granular form was given in a single dose of 6 mg/kg before meal peaked at 0.81 micrograms/ml 6 hours after dosing. The serum half-life of the drug was 2.45 hours. 2. CFDN was administered to 18 patients with bacterial infections which consisted mainly of respiratory tract infections in doses of 1.3-7.4 mg/kg three times daily for 3-9 days. Clinical efficacies were "excellent" in 10 patients, "good" in 7, and "poor" in one, with an overall efficacy rate of 94.4%. 3. As for bacteriological effects on 20 strains of causative organisms, all the 10 strains of Gram-positive organisms were eradicated, with an eradication rate of 100%. Meanwhile, the eradication rate on 10 strains of Gram-negative organisms was 87.5%. Overall, bacteriological effect was "eradicated" in 17 strains, "decreased" in one, and "unknown" in 2, with an eradication rate of 94.4%. 4. No side effects nor abnormal laboratory test values were noted in any of the patients. We have concluded that cefdinir is useful in the treatment of infection in the pediatric field.