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[Pharmacokinetic studies on oral antibiotics in pediatrics. I. A pharmacokinetic study on cefixime in pediatrics]
1Department of Pediatrics, Meitetsu Hospital.
Insights
Administering cefixime (CFIX) granules before meals in children may enhance absorption, though results were not statistically significant. CFIX demonstrated a dose-dependent response in pediatric patients.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Drug Metabolism
Background:
- Cefixime (CFIX) is a third-generation cephalosporin antibiotic used for pediatric infections.
- Understanding cefixime pharmacokinetics in children is crucial for optimizing therapeutic efficacy and safety.
Purpose of the Study:
- To evaluate the impact of meal timing on cefixime pharmacokinetics in school-aged children.
- To assess the dose-response relationship and pharmacokinetic parameters of cefixime granules in pediatric populations.
- To compare cefixime absorption and excretion across different pediatric age groups.
Main Methods:
- A crossover design was used to administer cefixime (CFIX) 5% granules at 3 mg/kg, either 30 minutes before or after meals.
- Serum concentrations and urinary excretion rates were determined.
- Dose-ranging studies (3 mg/kg vs. 6 mg/kg) and age-group comparisons (school children, younger children, infants) were conducted.
Main Results:
- Administration before meals showed a trend towards earlier Tmax, higher Cmax, and increased urinary excretion compared to post-meal administration, though not statistically significant.
- A clear dose-response relationship was observed for Cmax and AUC in both school children and infants.
- School children exhibited earlier Tmax compared to younger children and infants.
Conclusions:
- Meal timing may influence cefixime absorption, with pre-meal administration potentially being more favorable.
- Cefixime exhibits dose-proportional pharmacokinetics in pediatric patients.
- Age influences cefixime Tmax, with younger children and infants showing longer absorption times.
Abstract:
A pharmacokinetic study on cefixime (CFIX) 5% granules for pediatric use was performed, and pharmacokinetic parameter were calculated. 1. Six school children 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 crossover design, and serum concentrations and urinary excretion rates of CFIX were determined. Tmax, Cmax, T 1/2 and urinary excretion rate (0-12 hours) following the administration before meal were 3.33 +/- 0.42 hours, 1.03 +/- 0.17 micrograms/ml, 2.31 +/- 0.26 hours and 15.3 +/- 2.2%, respectively, Tmax, Cmax, T 1/2 and urinary excretion rate following the the administration after meal were 4.00 +/- 0.52 hours, 0.90 +/- 0.09 micrograms/ml, 3.11 +/- 0.21 hours and 11.3 +/- 1.6%, respectively. Earlier Tmax, higher Cmax and higher urinary excretion 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. Cmax and AUC at a dose level of 3 mg/kg were 1.01 +/- 0.26 mg/ml and 5.86 +/- 1.13 micrograms.hr/ml, respectively, and Cmax and AUC at a dose level of 6 mg/kg were 1.76 +/- 0.29 micrograms/ml, 12.54 +/- 1.77 micrograms.hr/ml, respectively. A dose response relationship was thus observed. Seven infants (3 mg/kg) and 3 infants (6 mg/kg) were administered orally with CFIX granules at 30 minutes after meal. Cmax and AUC at a dose level of 3 mg/kg were 2.45 +/- 0.26 micrograms/ml, 33.50 +/- 7.62 micrograms.hr/ml, respectively, and Cmax and AUC at a dose level of 6 mg/kg were 4.42 +/- 0.98 micrograms/ml, 66.85 +/- 25.19 micrograms.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. Tmax 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 Tmax's were observed in school children than in other children. Cmax in school children, younger children and infants were 0.95 +/- 0.12 micrograms/ml, 0.56 +/- 0.06 micrograms/ml and 2.45 +/- 0.26 micrograms/ml, respectively.(ABSTRACT TRUNCATED AT 400 WORDS)