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[Clinical studies on cefprozil granules in pediatrics]
1Department of Pediatrics, Tokyo Ebara Municipal Hospital.
Insights
Cefprozil (CFPZ) demonstrated high clinical efficacy and favorable pharmacokinetics in pediatric patients. This new oral cephalosporin showed a 92.7% efficacy rate with minimal side effects, making it a promising option for pediatric infections.
Area of Science:
- Pharmacology
- Pediatric Infectious Diseases
- Clinical Pharmacy
Background:
- Cefprozil (CFPZ) is a novel oral cephalosporin antibiotic.
- Pediatric infections require effective and safe treatment options.
Purpose of the Study:
- To evaluate the clinical efficacy and pharmacokinetics of Cefprozil (CFPZ) in pediatric patients.
- To assess the safety profile of Cefprozil (CFPZ) in this population.
Main Methods:
- Pharmacokinetic study in 6 pediatric patients receiving single doses of 7.5 or 15.0 mg/kg.
- Clinical evaluation in 41 pediatric patients with various infections, treated with CFPZ (9.0-45.0 mg/kg daily for 3-14 days).
- Serum and urinary concentrations, peak serum concentrations, biological half-lives, and urinary recovery rates were determined.
Main Results:
- Peak serum concentrations of 2.13 and 6.22 µg/ml were observed at 2 hours for 7.5 and 15.0 mg/kg doses, respectively.
- Biological half-lives were 1.06 and 1.36 hours, with urinary recovery rates of 44.8% and 56.1%.
- An overall clinical efficacy rate of 92.7% was achieved across various infections, including tonsillitis and urinary tract infections. Bacterial eradication rate was 79.2%.
Conclusions:
- Cefprozil (CFPZ) exhibits favorable pharmacokinetic properties and high clinical efficacy in pediatric patients.
- The antibiotic demonstrated a good safety profile with no observed side effects, except for eosinophilia in two patients.
- Cefprozil (CFPZ) is a potentially valuable therapeutic agent for treating infections in children.
Abstract:
Cefprozil (CFPZ, BMY-28100) granules was administered to a group of pediatric patients. The new oral cephalosporin, CFPZ, was evaluated clinically in 42 pediatric patients, and a pharmacokinetic study was performed in 6 patients. Serum and urinary concentrations of CFPZ were determined in 6 patients who were given single dose of 7.5 or 15.0 mg/kg. Serum concentrations were determined at 1, 2, 3, 4 and 6 hours after dosing. Urinary concentrations were measured for periods of 0-6 hours after dosing. With oral administrations of 7.5 mg/kg and 15.0 mg/kg, peak serum concentrations were 2.13 micrograms/ml and 6.22 micrograms/ml, respectively, at 2 hours, and biological half-lives were 1.06 hours and 1.36 hours, respectively. Urinary recovery rates were 44.8% and 56.1%. The clinical evaluation was conducted in 41 patients including 16 patients with acute tonsillitis, 8 patients with lacunar tonsillitis, 4 patients with scarlet fever, 3 patients with acute bronchitis, 1 patient each with pertussis, furuncle, impetigo and lymphadenitis, and 6 patients with urinary tract infections. The ages of the patients were 10 month to 11 years 1 month, and they were treated with CFPZ at doses ranging 9.0-45.0 mg/kg daily for 3-14 days, the overall clinical efficacy rate was 92.7%. An eradication rate of 79.2% was achieved for 28 strains of 8 species identified in the patients. No side effects were observed. Abnormal laboratory test results obtained were eosinophilia in 2 patients.