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Pharmacokinetics of cefprozil in infants and children
X Sáez-Llorens1, W C Shyu, S Shelton
1Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas 75235.
Insights
This study evaluated cefprozil pharmacokinetics in pediatric patients. Higher doses of cefprozil resulted in increased drug exposure and longer half-lives, indicating dose-dependent absorption in children.
Area of Science:
- Pharmacology
- Pediatric Pharmacokinetics
- Antibiotic Therapy
Background:
- Cefprozil is a widely used cephalosporin antibiotic.
- Understanding cefprozil pharmacokinetics in pediatric populations is crucial for optimizing dosing regimens.
- Previous studies have established cefprozil's efficacy, but detailed pharmacokinetic data in children are essential.
Purpose of the Study:
- To determine the pharmacokinetic profile of cefprozil following single oral administration in pediatric patients.
- To assess the dose-proportionality of cefprozil absorption and disposition in children aged 8 months to 8 years.
- To characterize the plasma concentrations, half-life, and area under the curve (AUC) of cefprozil and its isomers.
Main Methods:
- Twenty pediatric patients received single oral doses of cefprozil at 15 mg/kg and 30 mg/kg.
- Plasma samples were collected at multiple time points post-administration.
- Drug concentrations were determined using microbiological assay and high-pressure liquid chromatography (HPLC) for cefprozil and its isomers.
Main Results:
- Peak plasma concentrations and AUC of cefprozil increased with higher doses (15 vs. 30 mg/kg).
- Mean half-lives ranged from 1.77 to 2.14 hours for cefprozil, showing dose-dependency.
- HPLC analysis revealed distinct pharmacokinetic parameters for the cis and trans isomers of cefprozil.
Conclusions:
- Cefprozil exhibits dose-proportional pharmacokinetics in pediatric patients within the studied age range.
- The observed half-lives and AUC values support the established dosing guidelines for cefprozil in children.
- Further research may explore the impact of age and weight on cefprozil's pharmacokinetic variability in pediatric populations.
Abstract:
Twenty pediatric patients (ages, between 8 months and 8 years) received a single oral dose of cefprozil at levels of 15 and 30 mg/kg of body weight. Cefprozil consists of cis (BMY-28100) and trans (BMY-28167) isomers in an approximately 90:10 ratio. Six plasma samples were collected from each pediatric patient and assayed for drug concentrations. As measured by a microbiological assay, peak concentrations of 11.16 and 15.93 micrograms of cefprozil per ml occurred at 1 h for patients who received the 15- and 30-mg/kg doses, respectively. The respective mean half-lives of cefprozil were 1.77 and 2.14 h, and the respective mean areas under the curve were 28.05 and 45.28 micrograms.h/ml for patients who received the 15- and 30-mg/kg doses. When measured by a high-pressure liquid chromatography method, peak concentrations of 12.09 and 18.04 micrograms of the cis isomer per ml were obtained at 1 h, with mean half-lives of 1.63 and 2.06 h and mean areas under the curve of 30.48 and 49.34 micrograms.h/ml in patients who received the 15- and 30-mg/kg doses, respectively. For the trans isomer, peak concentrations of 1.16 and 1.63 micrograms/ml occurred at 1 h, respectively, with mean half-lives of 1.61 and 1.65 h and mean areas under the curve of 2.89 and 4.34 micrograms.h/ml in patients who received the 15- and 30-mg/kg doses, respectively.