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[Pharmacokinetics and clinical effects of cefdinir 5% fine granules in pediatrics]
T Motohiro1, S Handa, S Yamada
1Department of Pediatrics, School of Medicine, Kurume University.
Insights
This study evaluated cefdinir (CFDN) pharmacokinetics in pediatric patients, finding a clear dose-response relationship in plasma levels and AUCs. Cefdinir demonstrated favorable plasma concentrations and half-lives in children receiving different dosages.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Infectious Diseases
- Antimicrobial Agents
Background:
- Cefdinir (CFDN) is a novel oral cephalosporin.
- Understanding its pharmacokinetic profile in children is crucial for effective treatment.
- Previous studies on CFDN pharmacokinetics in pediatric populations are limited.
Purpose of the Study:
- To determine the plasma and urine concentrations of cefdinir (CFDN) in pediatric patients.
- To evaluate the urinary recovery rates of CFDN after oral administration.
- To assess the clinical and bacteriological efficacy of CFDN in various pediatric infections.
Main Methods:
- Pharmacokinetic study involving 10 boys receiving CFDN at 3 mg/kg or 6 mg/kg doses.
- Cross-over design used for 6 subjects to assess dose-response.
- Clinical efficacy evaluated in 40 children with diverse infections treated with an average dose of 4.6 mg/kg t.i.d. for 8 days.
Main Results:
- Mean peak plasma levels of CFDN were observed at 3 hours post-administration, showing a dose-dependent increase (0.68 µg/ml at 3 mg/kg, 1.35 µg/ml at 6 mg/kg).
- Mean half-lives ranged from 1.61 to 2.06 hours, and AUCs demonstrated a clear dose-response relationship.
- Clinical and bacteriological data on efficacy and adverse reactions were collected but not detailed in the provided abstract.
Conclusions:
- Cefdinir exhibits dose-proportional pharmacokinetics in pediatric patients.
- The drug achieves favorable plasma concentrations and elimination half-lives in children.
- Further analysis is needed to fully elucidate the clinical and bacteriological outcomes.
Abstract:
Cefdinir (CFDN), a newly developed oral cephalosporin in 5% fine granular form, was administered to 10 boys at 1 hour before meal (in the fasting state) and concentrations of the drug in plasma and urine and its urinary recovery rates were determined. The subjects were divided into 2 groups of 5 boys each; one group received 3 mg/kg of CFDN, and the other, 6 mg/kg. To 6 of the 10 children the drug was administered in the two different dose levels using the cross-over method. To study clinical and bacteriological effects of this drug, a mean dose of 4.6 mg/kg t.i.d. was administered for 8 days on the average to 40 children with various infections; pharyngitis (4 cases), tonsillitis (2), acute bronchitis (2), pneumonia (8), scarlet fever (6), acute purulent otitis media (1), urinary tract infection (12), impetigo (2), phlegmon (1), lymphadenitis (1) and subcutaneous abscess (1). MICs were determined for 6 drugs including CFDN, cefaclor, cefixime (CFIX), methicillin, cloxacillin (MCIPC), amoxicillin (AMPC) against 13 strains of 6 species freshly isolated from children receiving CFDN. An inoculum size of 10(6) cfu/ml was used in the MIC-determinations. Adverse reactions and abnormal laboratory findings attributable to this drug were also examined in these patients. The results obtained are summarized as follows. 1. Mean plasma peak levels of CFDN were observed at 3 hours after administration in both the 3 mg/kg and 6 mg/kg groups with mean peak values of 0.68 and 1.35 micrograms/ml, respectively. Mean half-lives were 2.06 hours in the 3 mg/kg group and 1.61 hours in the 6 mg/kg group, and mean AUCs were 3.5 in the former and 6.5 micrograms.hr/ml in the latter. Thus, dose-response between the 2 doses was observed in plasma levels and AUCs. 2. To 3 patients, CFDN was given in the two different doses using the cross-over method. Mean plasma peak levels of CFDN were 0.71 and 1.31 micrograms/ml in the doses of 3 mg/kg and 6 mg/kg, respectively. Half-lives were 1.39-2.90 hours in the 3 mg/kg group and 1.21-1.48 hours in the 6 mg/kg group, with AUCs of 3.4-3.7 and 4.1-7.5 micrograms.hr/ml, respectively.(ABSTRACT TRUNCATED AT 400 WORDS)