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[Clinical study on cefdinir in pediatric field]
1Department of Infectious Diseases, Tokyo Metropolitan Komagome Hospital.
Insights
Cefdinir (CFDN), an oral cephalosporin, demonstrated a 96% efficacy rate in treating pediatric infections with no significant side effects. Pharmacokinetic studies showed variable plasma levels and urinary recovery in children.
Area of Science:
- Pharmacology
- Pediatrics
- Infectious Diseases
Background:
- Cefdinir (CFDN) is a novel oral cephalosporin antibiotic.
- Understanding its pharmacokinetic and clinical profile is crucial for pediatric use.
Purpose of the Study:
- To evaluate the pharmacokinetics and clinical efficacy of cefdinir in pediatric patients.
- To assess the safety and tolerability of cefdinir in children.
Main Methods:
- Pharmacokinetic analysis in two pediatric patients administered 3 mg/kg of CFDN.
- Clinical efficacy assessment in 25 children with various infectious diseases.
- Monitoring of clinical laboratory tests for safety evaluation.
Main Results:
- Peak plasma concentrations of CFDN varied between patients.
- High clinical efficacy rate of 96% (24/25) and bacteriological eradication rate of 83.3% (10/12) were observed.
- No serious adverse events were reported; minor elevations in eosinophils and GPT were noted.
Conclusions:
- Cefdinir exhibits promising pharmacokinetic properties and high clinical effectiveness in pediatric infectious diseases.
- The safety profile of cefdinir in children appears favorable, with minimal laboratory abnormalities.
Abstract:
We studied pharmacokinetics and clinical effects of cefdinir (CFDN), a newly developed oral cephalosporin, and the following results were obtained. 1. Pharmacokinetics of CFDN in 2 patients were investigated. The 2 patients with ages of 8 years (36.5 kg, body weight) and 6 years (26.5 kg, body weight) were administered with 3 mg/kg of fine granules of CFDN on empty stomachs. Peak plasma levels of CFDN were 0.85 microgram/ml in one patient and 0.56 microgram/ml in the other. The 8-hour urinary recovery rate was 21.6% of the administered dose in one and was not calculable in the other. 2. Clinical effects of CFDN were studied in 25 children with various infectious diseases: 11 with acute pharyngitis, 1 with acute tonsillitis, 2 with acute laryngitis, 3 with acute bronchitis, 2 with acute bronchopneumonia, 4 with scarlet fever, 1 with acute otitis media, 1 with acute lymphadenitis. The efficacy rate was 96% (24/25), and the bacteriological eradication rate was 83.3% (10/12). 3. No side effects were noted. Clinical laboratory test values were investigated in 14 patients. There were no seriously abnormal laboratory test findings except a slight elevation of eosinophile and GPT.