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Pharmacokinetics of cefpirome in pediatric patients
M C Nahata1, W J Barson, S K Puri
1College of Pharmacy, Ohio State University, Columbus 43210, USA.
Insights
Cefpirome, an investigational cephalosporin, shows favorable pharmacokinetics and tolerance in pediatric patients. This study provides key data for future pediatric efficacy and safety trials of cefpirome.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Infectious Diseases
Background:
- Cefpirome is an investigational cephalosporin antibiotic.
- Limited pharmacokinetic and tolerance data exist for cefpirome in pediatric populations.
Purpose of the Study:
- To determine the pharmacokinetics of cefpirome in pediatric patients.
- To assess the tolerance of cefpirome in pediatric patients.
Main Methods:
- A single intravenous dose of cefpirome (10, 25, or 50 mg/kg) was administered to 18 pediatric patients (0.5-18 years).
- Blood samples were collected over 8 hours post-dose for cefpirome concentration measurement using high-performance liquid chromatography.
- Pharmacokinetic parameters including maximum serum concentration, clearance, volume of distribution, and half-life were calculated.
Main Results:
- Maximum serum concentrations of cefpirome ranged from 53.6 to 454 µg/ml across the tested doses.
- Mean pharmacokinetic parameters were: total body clearance 2.15 ± 0.70 ml/min/kg, apparent volume of distribution 0.32 ± 0.32 L/kg, and elimination half-life 1.8 ± 1.3 h.
- No significant adverse effects were attributed to cefpirome administration.
Conclusions:
- Cefpirome exhibits predictable pharmacokinetics in pediatric patients across a range of doses.
- The antibiotic was well-tolerated in this pediatric cohort.
- These findings support further investigation into cefpirome's efficacy and safety in pediatric populations.
Abstract:
Cefpirome is a new investigational cephalosporin. We designed a study to determine the pharmacokinetics and tolerance of cefpirome in pediatric patients. A single dose of cefpirome was administered intravenously over 15 min to 18 patients (age 0.5 to 18 years). The doses were 10 mg/kg of body weight for five patients, 25 mg/kg of body weight for seven patients, and 50 mg/kg of body weight for six patients. Blood samples were collected at 0, 0.25, 0.5, 1, 3, 5, and 8 h after the dose, and cefpirome was measured by a high-performance liquid chromatography method. The maximum concentration in serum ranged from about 53.6 to 454 micrograms/ml after doses of 10 to 50 mg/kg. The total body clearance, apparent volume of distribution, and elimination half-life were 2.15 +/- 0.70 ml/min/kg, 0.32 +/- 0.32 liter/kg, and 1.8 +/- 1.3 h, respectively. No significant adverse effects were attributed to cefpirome. These data may be useful in conducting efficacy and safety studies of cefpirome in pediatric patients.