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[Pharmacokinetic study on oral antibiotics in pediatrics. III. A pharmacokinetic study on cefprozil in pediatrics]
1Department of Pediatrics, Meitetsu Hospital.
Insights
Cefprozil (CFPZ) absorption and excretion in children are influenced by food intake, with higher Cmax and urinary recovery when taken before meals. Age also impacts pharmacokinetics, with infants showing longer Tmax and T1/2.
Area of Science:
- Pediatric pharmacokinetics
- Antibiotic absorption and excretion
Background:
- Understanding cefprozil (CFPZ) pharmacokinetics in pediatric populations is crucial for optimizing therapeutic efficacy.
- Previous studies have indicated potential variability in drug absorption and elimination based on physiological factors.
Purpose of the Study:
- To investigate the influence of food, dose, and age on the pharmacokinetic profile of cefprozil in pediatric patients.
- To determine optimal administration conditions for cefprozil in children.
Main Methods:
- A crossover design was employed to assess the effect of food (before vs. after meal) and dose (7.5 mg/kg vs. 15.0 mg/kg) in school children.
- Pharmacokinetic parameters including Tmax, Cmax, T1/2, and urinary recovery were analyzed.
- The influence of age was studied by administering cefprozil to school children, younger children, and infants.
Main Results:
- Administration of cefprozil before meals resulted in a shorter Tmax, higher Cmax, and increased urinary recovery compared to administration after meals.
- Dose-dependent effects were observed for Cmax and AUC, with higher doses yielding greater values.
- Infants exhibited a significantly longer Tmax and T1/2 compared to older children, and urinary recovery rates varied across age groups.
Conclusions:
- Food intake significantly affects cefprozil absorption, with pre-meal administration being more favorable.
- Cefprozil pharmacokinetics demonstrate dose-dependency and age-related differences in pediatric populations.
- These findings underscore the importance of considering food and age when prescribing cefprozil to children.
Abstract:
The absorption and excretion were studied in the field of pediatrics, and pharmacokinetic analyses were performed. 1. Influence of food: Cefprozil (CFPZ, BMY-28100) was given to 6 school children in a before and after meal cross over design. With before meal administration, Tmax was 1.11 +/- 0.08 hours, Cmax was 5.08 +/- 0.27 micrograms/ml, T 1/2 was 0.77 +/- 0.09 hour, and urinary recovery rate (0-8 hours) was 55.2 +/- 4.7%. With after meal administration, these values were 1.31 +/- 0.04 hours, 3.98 +/- 0.38 micrograms/ml, 0.72 +/- 0.03 hour and 46.3 +/- 9.0%, respectively. A shorter Tmax value was, obtained higher Cmax and more or less higher urinary recovery rate when the drug was administered before meal, hence the food was considered to influence the absorption of the drug. 2. Dose effect: CFPZ was given on empty stomach to 6 school children in doses of 7.5 mg/kg and 15.0 mg/kg in the cross over design. With the lower dose Cmax was 6.19 +/- 0.36 micrograms/ml and AUC was 14.90 +/- 1.02 micrograms.hr/ml, and with the higher dose they were 12.38 +/- 1.29 micrograms/ml and 28.56 +/- 1.79 micrograms.hr/ml. Dose effects appeared to exist for CFPZ. A higher urinary recovery rate was obtained at the dosage of 7.5 mg/kg (82.1 +/- 6.4%) compared to the dosage of 15.0 mg/kg (51.1 +/- 7.1%). 3. Influence of age: CFPZ was given on empty stomach to 17 school children, 19 younger children and 5 infants. Tmax were 1.07 +/- 0.09, 1.06 +/- 0.07, and 1.40 +/- 0.09 hours, respectively for the 3 groups, hence significantly longer Tmax was observed in infants. Cmax were higher in older children and they were 5.62 +/- 0.38, 4.72 +/- 0.53 and 4.05 +/- 0.33 micrograms/ml, in the 3 age groups, respectively. T 1/2 were 0.73 +/- 0.04, 0.78 +/- 0.09 and 0.98 +/- 0.12 hour, respectively, it was longer in infants. The AUCs were not different among the 3 groups, but different urinary recovery rates were obtained with higher recovery in school children, with values of 64.1 +/- 4.3, 44.3 +/- 3.8 and 51.6 +/- 3.3%, respectively.