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[Laboratory and clinical studies of cefdinir 5% and 10% fine granules in pediatric field]
T Nishimura1, K Tabuki, S Aoki
1Department of Pediatrics, Osaka Medical College.
Insights
Cefdinir (CFDN) fine granule preparations demonstrated good efficacy in treating pediatric bacterial infections, with minimal side effects. Pharmacokinetic studies showed favorable absorption and excretion profiles for both 5% and 10% formulations.
Area of Science:
- Pharmacology
- Pediatric Infectious Diseases
- Drug Development
Background:
- Cefdinir (CFDN) is a third-generation cephalosporin antibiotic used for bacterial infections.
- Development of fine granule preparations aims to improve pediatric drug administration and compliance.
Purpose of the Study:
- To evaluate the pharmacokinetics and clinical efficacy of cefdinir (CFDN) 5% and 10% fine granule preparations in pediatric patients.
- To assess the safety and tolerability of these cefdinir formulations.
Main Methods:
- Laboratory and clinical studies involving oral administration of CFDN 5% and 10% fine granules, and CFDN 100 mg capsules to pediatric subjects.
- Pharmacokinetic analysis including peak plasma levels, half-life, and urinary excretion rates.
- Clinical evaluation of treatment outcomes for various pediatric bacterial infections.
Main Results:
- CFDN 5% granules showed a mean peak plasma level of 0.76 µg/ml at 4 hours with a half-life of 1.77 hours.
- CFDN 10% granules exhibited a mean peak plasma level of 0.73 µg/ml at 2 hours with a half-life of 1.62 hours.
- Excellent or good treatment outcomes were observed in 100% of 48 cases treated with CFDN 5% and 93.75% of 16 cases treated with CFDN 10%.
Conclusions:
- Cefdinir fine granule preparations are effective and well-tolerated for treating pediatric bacterial infections.
- The pharmacokinetic profiles support the use of these cefdinir formulations in children.
- Further investigation into specific side effects like eosinophilia and gastrointestinal disturbances is warranted.
Abstract:
We have carried out laboratory and clinical studies on cefdinir (CFDN) 5% and 10% fine granule preparations. The results are summarized as follows. CFDN 5% fine granule preparation was given via oral route to each of 2 children in the fasting state at a single dose of 3 mg/kg. After administration, the mean peak plasma level of CFDN was 0.76 micrograms/ml at 4 hours and the mean half-life was 1.77 hours. The mean urinary excretion rate of CFDN was 31.5% in the first 12 hours after oral administration. CFDN 10% fine granule preparation and CFDN 100 mg capsule were given via oral route 3 children and to another child in the fasting state at single doses of 3 mg/kg and 2.63 mg/kg, respectively. After administration of 10% granules the mean peak plasma level of CFDN was 0.73 micrograms/ml at 2 hours and the mean half-life was 1.62 hours. The peak serum level obtained after administration of CFDN 100 mg capsule was 0.91 micrograms/ml at 2 hours and the half-life was 1.08 hours. The mean urinary excretion rate obtained with CFDN 10% fine granules was 26.2% in the first 8 hours after oral administration and the urinary excretion rate obtained with CFDN 100 mg capsule was 19.7% in the first 12 hours after oral administration. Treatment with CFDN 5% fine granules was made for a total of 48 cases of pediatric bacterial infections including 21 cases of tonsillitis, 12 cases of scarlet fever, 3 cases of pharyngitis, 5 cases of impetigo, 1 case of subcutaneous abscess, 1 case of furuncle, 5 cases of UTI. Results obtained were excellent in 30 cases, good in 18 cases. Treatment with CFDN 10% fine granules was made for a total of 16 cases of pediatric bacterial infections including 6 cases of tonsillitis, 3 cases of pneumonia, 4 cases of scarlet fever, 2 cases of impetigo, 1 case of UTI. Results obtained were excellent in 8 cases, good in 7 cases, poor in 1 case. No significant side effects due to the drugs were observed except 2 cases (1 case with 5% preparation and another with 10%) with eosinophilia, 3 cases (all with 5%) with diarrhea and 1 case each of elevated GOT & GPT (with 5%) and elevated GOT, GPT & Al-P (with 10%).