[Pharmacokinetic studies on oral antibiotics in pediatrics. II. A pharmacokinetic study on cefteram pivoxil in pediatrics].

A pharmacokinetic study on cefteram pivoxil (CFTM-PI) granules and tablets for pediatric use was performed, and pharmacokinetic parameters were calculated using the one-compartment open model with a time lag. 1. Twelve school children were administered orally with CFTM-PI granules at a dose level of 3 mg/kg either at 30 minutes before meal or 30 minutes after meal on a crossover design, and serum concentrations and urinary excretion rates of CFTM were determined. Tmax, Cmax, T 1/2 and urinary excretion rate following the administration before meal were 1.3 +/- 0.1 hours, 1.35 +/- 0.11 micrograms/ml, 1.21 +/- 0.07 hours and 13.4 +/- 1.5%, respectively. Tmax, Cmax, T 1/2 and urinary excretion rate following the administration after meal were 2.9 +/- 0.3 hours, 1.08 +/- 0.09 microgram/ml, 1.72 +/- 0.26 hours and 23.3 +/- 2.2%, respectively. Earlier Tmax, higher Cmax and lower urinary excretion rate were observed when the drug was administered before meal than when administered after meal. 2. Six school children were administered orally with CFTM-PI granules at 30 minutes after meal at a dose level of either 3 mg/kg or 6 mg/kg on a crossover design, and serum concentrations and urinary excretion rates of CFTM were determined. Cmax at a dose level of 3 mg/kg was 1.50 +/- 0.26 microgram/ml, Cmax at a dose level of 6 mg/kg was 2.58 +/- 0.29 micrograms/ml. There existed dose response. 3. Eighteen school children, 10 younger children and 6 infants were administered orally with CFTM-PI granules at a dose level of 3 mg/kg at 30 minutes after meal, and serum concentrations and urinary excretion rates of CFTM were determined. Tmax in school children, younger children and infants were 2.8 +/- 0.3, 3.4 +/- 0.3 and 2.0 +/- 0.4 hours, respectively. Slightly earlier Tmax's were observed in infants than in other children. Cmax in school children, younger children and infants were 1.22 +/- 0.11, 1.03 +/- 0.12 and 0.94 +/- 0.15 micrograms/ml, respectively. It seemed slightly high in the older school children, younger children, infants. Although T 1/2 were nearly the same in all age groups, it seemed somewhat longer in school children than in others. Urinary excretion rates in school children, younger children and infants were 21.5 +/- 1.8, 19.3 +/- 2.0 and 7.6 +/- 0.1%, respectively. Obviously low excretion rates were observed in infants.(ABSTRACT TRUNCATED AT 400 WORDS)