[Pharmacokinetic, bacteriological and clinical studies on cefdinir fine granules in the field of pediatrics]
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Cefdinir (CFDN) demonstrated excellent clinical effectiveness and tolerability in pediatric patients with bacterial infections. This new oral antibiotic showed a 100% efficacy rate and was well-accepted by children.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Clinical Pharmacy
Background:
- Cefdinir (CFDN) is a third-generation cephalosporin antibiotic.
- Pediatric infections require effective and well-tolerated oral treatment options.
Purpose of the Study:
- To evaluate the pharmacokinetics and clinical effectiveness of cefdinir (CFDN) in pediatric patients.
- To assess the safety and tolerability of cefdinir (CFDN) in children.
Main Methods:
- Pharmacokinetic analysis of plasma concentrations and urinary excretion of CFDN in 4 children at 6 mg/kg.
- Clinical effectiveness assessment in 24 pediatric patients with various bacterial infections treated with CFDN granules (5% or 10%) at approximately 10 mg/kg/day.
- Bacteriological evaluation of causative organisms and eradication rates.
Main Results:
- Average peak plasma concentration of CFDN was 0.99 µg/ml with a half-life of 2.12 hours.
- Overall clinical efficacy rate was 100% (16 excellent, 7 good).
- Bacteriological eradication rate was 82.6% for identified pathogens; no significant side effects were observed.
Conclusions:
- Cefdinir (CFDN) exhibits favorable pharmacokinetics and high clinical effectiveness in pediatric patients.
- CFDN fine granule preparations are well-accepted by children and demonstrate usefulness in treating pediatric bacterial infections.
- The safety profile of CFDN in this pediatric population was excellent, with minimal laboratory abnormalities.
Abstract:
The Pharmacokinetics and clinical effectiveness of cefdinir (CFDN, FK482) were examined in pediatric patients. The results are summarized as follows. 1. Plasma concentrations and urinary excretions of CFDN after administration of 5% fine granules were investigated on 4 children at a dose level of 6 mg/kg. Average plasma concentrations peaked at 4 hours after administration at 0.99 micrograms/ml with a half-life of 2.12 hours. The first 24-hour urinary recovery rates of CFDN in 3 children averaged 22.0%. 2. CFDN was given to 24 children (11 with pharyngitis, 3 with tonsillitis, 8 with scarlet fever, 1 with urinary tract infection and 1 with enteritis due to Salmonella); 15 were treated with 5% fine granules and 9 with 10% fine granules at daily doses of about 10 mg/kg in 2 to 3 divided portions. Clinical effects were excellent in 16, good in 7 and not evaluable in 1, with an overall efficacy rate of 100%. 3. Identified causative organisms were 12 strains of Streptococcus pyogenes, 4 of Haemophilus influenzae, 5 of Haemophilus parainfluenzae, 1 of Escherichia coli, and 1 of Salmonella. Bacteriological effects were rated as "eradicated" for 19 strains, "unchanged" for 4 with an eradication rate of 82.6%. 4. No side effects were observed. As for abnormal laboratory test results, a transient decrease of white blood cells was observed in 1 patient. 5. The CFDN fine granule preparations were preferably accepted by the children. 6. The fine granular preparations of CFDN, a new oral antibiotic, were useful for the treatment of bacterial infections in pediatrics.