[Pharmacokinetic, bacteriological and clinical studies on cefprozil in pediatric patients]
Insights
Cefprozil (CFPZ) demonstrates potent antibacterial activity comparable to other antibiotics. This new oral cephem antibiotic proved 100% effective and safe in pediatric patients with various infections.
Area of Science:
- Pharmacology
- Microbiology
- Pediatrics
Background:
- Cefprozil (CFPZ) is a novel oral cephem antibiotic.
- Antibiotic resistance and efficacy are critical concerns in pediatric infectious diseases.
Purpose of the Study:
- To evaluate the antibacterial spectrum, pharmacokinetics, and clinical efficacy of Cefprozil (CFPZ) in pediatric patients.
- To assess the safety profile of Cefprozil (CFPZ) in this population.
Main Methods:
- Antibacterial activity of CFPZ was tested against 11 clinical isolates from 6 species.
- Pharmacokinetic parameters including serum concentration and urinary excretion were measured after oral administration (15 mg/kg).
- Clinical efficacy and safety were assessed in 25 pediatric patients with infections.
Main Results:
- CFPZ exhibited antibacterial activity equal to or greater than Cefaclor (CCL) against Staphylococcus aureus, alpha-hemolytic Streptococcus, Escherichia coli, and Haemophilus influenzae.
- Peak serum concentrations of CFPZ were achieved within 1-2 hours post-administration, with a 6-hour urinary excretion rate of 33.8%.
- A 100% efficacy rate was observed in 25 pediatric patients, with 15 excellent and 10 good responses. Adverse events were mild, including soft stool and transient laboratory abnormalities.
Conclusions:
- Cefprozil (CFPZ) is a highly effective oral antibiotic against common pediatric pathogens.
- CFPZ demonstrates favorable pharmacokinetic properties and a strong safety profile for use in pediatric infectious diseases.
Abstract:
Cefprozil (CFPZ, BMY-28100), a new oral cephem antibiotic, was studied for its antibacterial activities, absorption and excretion upon administration. Its clinical efficacies were also studied in pediatric patients with infections. A study on antibacterial activities of CFPZ against 11 clinical isolates including 6 species found that its activities against Staphylococcus aureus, alpha-hemolytic Streptococcus, Escherichia coli and Haemophilus influenzae were equal or superior to those of CCL. When CFPZ was given to patients orally at 15 mg/kg, maximum serum concentration was obtained between 1 to 2 hours after administration and urinary excretion rate in the first 6 hours was 33.8 +/- 17.6%. Clinical evaluation was done in a total of 25 patients with various infections. Responses were excellent in 15 cases and good in 10 cases, hence the efficacy rate was 100%. As side effect, soft stool was found in 1 case, and eosinophilia in 2 cases and elevation of GOT and GPT in 1 case were found as abnormal laboratory test results, but none of them was serious. It appears that CFPZ is an effective and safe antibiotic in the field of pediatrics.
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