A pharmacokinetic study on cefixime (CFIX) 5% granules for pediatric use was performed, and pharmacokinetic parameter were calculated.
1. Six school chidren were administered orally with CFIX granules at a dose level of 3 mg/kg either at 30 minutes before meal or at 30 minutes after meal on a crossoverdesign, and serum concentrations and urinary excretion rates of CFIX were determined. T
max, C
max, T 1/2 and urinary excretion rate (0-12 hours) following the administration before meal were 3.33±0.42 hours, 1.03 ±0.17μg/ml, 2.31 ± 0.26 hours and 15.3 ±2.2%, respectively, T
max, C
max, T 1/2 and urinary excretion rate following the the administration after meal were 4.00±0.52 hours, 0.90±0.09 μg/ml, 3.11-1-0.21 hours and 11.3 ± 1.6%, respectively. Earlier T
max, higher Cr., and higher urinaryexcretion rate were observed when the drug was administered before meal than when administered after meal. These differences between the 2 groups were not statistically significant.
2. Five school children were administered orally with CFIX 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 CFIX were determined. C. and AUC at a dose level of 3 mg/kg were 1.01 ± 0.26 mg/ml and 5.86± 1.13 ug hr/ml, respectively, and C
max and AUC at a dose level of 6 mg/kg were 1.76 ±0.29, μg/ml, 12.54± 1.77 μgμhr/ml, respectively. A dose response relationship was thus observed.
Seven infants (3mg/kg) and 3 infants (6mg/kg) were administered orally with CFIX granules at 30 minutes after meal. C
max and AUC at a dose level of 3 mg/kg were 2.45-10.26, μg/ml, 33.50± 17.62, μg·hr/ml, respectively, and C
max and AUC at a dose levelof 6 mg/kg were 4.42 ± 0.98μg/ml, 66.85 ± 25.19 μg·hr/ml, respectively. A dose response was observed.
3. Eleven school children, 5 younger children and 7 infants were administered orally with CFIX granules at a dose level of 3 mg/kg at 30 minutes after meal, and serum concentrations and urinary excretion rates of CFIX were determined. T
max in school children, younger children and infants were 3.82 ±0.33 hours, 5.20±0.49 hours and 5.43±0.37 hours, respectively. Earlier T
max's were observed in school children than in other children. C
max in school children, younger children and infants were 0.95±0.12 μg/ml, 0.56 ± 0.06 μg/ml and 2.45 ±0.26, ag/ml, respectively. It seemed to be the highest in the infants, then followed by the school children and the younger children.
T 1/2 in school children, younger children and infants were 2.85 0.18 hours, 3.94±0.96 hours, and 6.72 ±1.31 hours. Longer T 1/2's were observed in the infants. As for AUC andurinary excretion rate, higher AUC and urinary excretion were observed in infants than in the other children.
View full abstract