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[Laboratory and clinical studies on cefdinir (10% fine granules) in pediatric field]
1Department of Pediatrics, Anjo Kosei Hospital.
Insights
This study evaluated cefdinir (CFDN) in children, finding it effective for bacterial infections with a 90.9% efficacy rate. Cefdinir demonstrated favorable pharmacokinetics and a good safety profile in pediatric patients.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and pharmacokinetics
- Antibiotic therapy
Background:
- Cefdinir (CFDN) is a new cephem antibiotic.
- Pediatric clinical studies are essential for evaluating new antibiotics in children.
Purpose of the Study:
- To assess the pharmacokinetics, clinical efficacy, and safety of 10% fine granules of cefdinir (CFDN) in pediatric patients.
- To evaluate CFDN's effectiveness in treating various pediatric bacterial infections.
Main Methods:
- Pharmacokinetic analysis of cefdinir plasma half-lives and urinary excretion rates in children.
- Clinical evaluation of cefdinir in 11 pediatric patients with bacterial infections, including scarlet fever, pharyngotonsillitis, acute bronchitis, pneumonia, and urinary tract infections.
- Monitoring for adverse events and laboratory abnormalities.
Main Results:
- Cefdinir plasma half-lives were 1.77 hours (3 mg/kg) and 1.47 hours (6 mg/kg).
- Eight-hour urinary excretion rates were 21.5% (3 mg/kg) and 16.4% (6 mg/kg).
- An overall clinical efficacy rate of 90.9% was observed across treated pediatric patients. Loose stool was the only reported adverse event in one patient, with no significant laboratory abnormalities.
Conclusions:
- Cefdinir exhibits favorable pharmacokinetic properties in children.
- Cefdinir is an effective and safe antibiotic for treating common pediatric bacterial infections.
- The 10% fine granule formulation of cefdinir is well-tolerated in pediatric patients.
Abstract:
Clinical studies on 10% fine granules of cefdinir (CFDN), a new cephem antibiotic, were carried out in the field of pediatrics. The results obtained are summarized as follows. 1. Half-lives of CFDN in plasma in 3 children when administered on an empty stomach were 1.77 hours (3 mg/kg per os) and 1.47 hours (6 mg/kg per os), respectively. Eight hour urinary excretion rates of CFDN were 21.5% (3 mg/kg per os) and 16.4% (6 mg/kg per os), respectively. 2. CFDN was administered to 11 children with various bacterial infections: 1 patient with scarlet fever, 1 with pharyngotonsillitis, 3 with acute bronchitis, 3 with pneumonia and 3 with urinary tract infections. The overall clinical efficacy rate was 90.9%. 3. Loose stool was noted in 1 patient. No abnormal laboratory test values were encountered.