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[Clinical and pharmacokinetic evaluation of cefteram pivoxil in children]
H Sakata1, H Kakehashi, K Fujita
1Department of Pediatrics, Asahikawa Medical College.
Insights
Cefteram pivoxil (CFTM-PI) demonstrated good clinical efficacy in pediatric patients with various infections. Mild, transient elevations in liver enzymes were observed in some cases.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Clinical Therapeutics
Context:
- Bacterial infections are common in children, necessitating effective and safe antibiotic treatments.
- Cefteram pivoxil (CFTM-PI) is a third-generation cephalosporin antibiotic with a broad spectrum of activity.
- Evaluating the clinical utility and safety profile of CFTM-PI in pediatric populations is crucial for its appropriate application.
Purpose:
- To assess the clinical efficacy of cefteram pivoxil (CFTM-PI) in treating a range of bacterial infections in children.
- To evaluate the safety and side effect profile of CFTM-PI in pediatric patients.
- To investigate the pharmacokinetics of CFTM-PI, including serum concentrations and urinary excretion, in children.
Summary:
- Twenty-six pediatric patients (8 months to 9 years) with infections including tonsillitis, urinary tract infections, and skin infections received CFTM-PI (7.5-20.1 mg/kg/day for 4-19 days).
- Clinical efficacy was rated as excellent in 11, good in 13, and fair in 2 patients. Two patients experienced transient elevations in liver enzymes (GOT, GPT).
- Pharmacokinetic studies in 9 children (2-11 years) showed peak serum concentrations of CFTM ranging from 0.99 to 1.25 mcg/ml at 1-2 hours post-dose, with urinary excretion varying by dosage.
Impact:
- CFTM-PI shows promising clinical effectiveness for common pediatric infections, with a generally favorable safety profile.
- The pharmacokinetic data provides insights into drug absorption and elimination, aiding in dosage optimization for pediatric use.
- This study supports the use of CFTM-PI as a therapeutic option in pediatric infectious disease management.
Abstract:
Twenty-six children were treated with cefteram pivoxil (CFTM-PI) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 8 months to 9 years. Doses of CFTM-PI ranged 7.5-20.1 mg/kg/day for 4 to 19 days. The twenty-six patients including 10 patients with tonsillitis, 1 pharyngitis, 3 otitis media, 2 scarlet fever, 1 bronchopneumonia, 1 lymphadenitis, 6 urinary tract infections, 1 vaginitis and 1 staphylococcal scalded skin syndrome were evaluated for clinical efficacy. Results were excellent in 11, good in 13, and fair in 2 patients. Out of the 26 patients, one case showed elevated GOT and GPT, and another case showed elevated GOT. The pharmacokinetic study of CFTM-PI was performed in 9 fasting patients whose ages ranged from 2 to 11 years. Serum peak concentrations of CFTM were 0.92 to 1.05 micrograms/ml (mean 0.99 microgram/ml) at 1 to 2 hours after a dose of 1.5 mg/kg each to 3 patients, 1.12 to 1.38 micrograms/ml (mean 1.25 micrograms/ml) after a dose of 3 mg/kg each to 3 patients and 0.66 to 2.1 micrograms/ml (mean 1.17 micrograms/ml) after a dose of 6 mg/kg each to 3 patients. The portions of the drug excreted into urine within 8 hours were 8.9% and 14.7% in 2 patients, each given a dose of 1.5 mg/kg, from 13.0 to 23.1% (mean 18.4%) in 3 patients, each given a dose of 3 mg/kg, and 6.3% and 8.7% in 2 patients, each given a dose of 6 mg/kg.