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[Laboratory and clinical studies on cefprozil granules in pediatrics]
Insights
Cefprozil (CFPZ) granules demonstrated high clinical efficacy (95.1%) and a 84.6% bacteriological eradication rate in pediatric infections. This new oral cephalosporin antibiotic showed favorable pharmacokinetics and was well-tolerated, with minor side effects observed.
Area of Science:
- Pharmacology
- Pediatric Infectious Diseases
- Antimicrobial Therapy
Background:
- Cefprozil (CFPZ) is a novel oral cephalosporin antibiotic.
- Investigating its efficacy and safety in pediatric patients is crucial for expanding its clinical application.
Purpose of the Study:
- To evaluate the fundamental and clinical effects of cefprozil (CFPZ) granules in pediatric patients.
- To assess the pharmacokinetic profile, clinical efficacy, and safety of CFPZ in children.
Main Methods:
- Pharmacokinetic study in one child receiving a single 7.5 mg/kg dose of CFPZ.
- Clinical efficacy assessment in 41 children with various infections (respiratory, skin, urinary tract).
- Monitoring of adverse events and laboratory test results.
Main Results:
- Cefprozil exhibited a peak serum concentration of 4.51 µg/ml at 2 hours, with a half-life of 0.98 hours.
- High clinical efficacy (95.1%) and bacteriological eradication rate (84.6%) were observed across different pediatric infections.
- Two patients experienced transient side effects: elevated liver enzymes (GOT/GPT) and eosinophilia.
Conclusions:
- Cefprozil (CFPZ) demonstrates favorable pharmacokinetics and significant clinical effectiveness in treating pediatric infections.
- The antibiotic is generally well-tolerated, with manageable side effects, supporting its use in pediatric populations.
- Further research may explore broader applications and long-term safety profiles of cefprozil in children.
Abstract:
Fundamental and clinical effects of cefprozil (CFPZ, BMY-28100) granules, a new oral cephalosporin antibiotic, in pediatric field were investigated. The result obtained were summarized as follows. 1. CFPZ (10% granules) was given to 1 child in a single dose of 7.5 mg/kg. The peak serum concentration of CFPZ was 4.51 micrograms/ml at 2 hours after administration. Half-life and AUC values were 0.98 hour and 20.7 micrograms.hr/ml. The mean peak urinary concentrations of CFPZ and 6 hours recovery rates were over 200 micrograms/ml at 2-6 hours and 27.6%, respectively. 2. Clinical efficacy of CFPZ was investigated in a total of 41 children, including 14 with upper respiratory tract infections, 6 with acute bronchitis and pneumonia, 2 with acute otitis media, 3 with skin and soft tissue infections and 16 with urinary tract infections. The clinical efficacy rate was 95.1%. The bacteriological eradication rate was 84.6%. 3. Two patients showed abnormal laboratory test results. One had elevations of both GOT and GPT, and another had eosinophilia which were attributed to this antibiotic as side effects.