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[Clinical and pharmacokinetic evaluation of ceftriaxone in children]
Insights
Ceftriaxone (CTRX) demonstrated good clinical efficacy in pediatric bacterial infections, with mild side effects observed. Pharmacokinetic studies showed variable serum half-lives and urinary recovery rates in children.
Area of Science:
- Pediatric Infectious Diseases
- Antibiotic Pharmacology
- Clinical Microbiology
Context:
- Bacterial infections are a significant cause of morbidity in children.
- Ceftriaxone is a commonly used broad-spectrum cephalosporin antibiotic.
- Evaluating the efficacy and safety of antibiotics in pediatric populations is crucial.
Purpose:
- To assess the clinical efficacy and side effects of ceftriaxone in pediatric patients.
- To determine the pharmacokinetic profile of ceftriaxone in children, including serum concentrations, half-life, and urinary excretion.
- To evaluate ceftriaxone's effectiveness in treating various pediatric bacterial infections.
Summary:
- Twenty-eight pediatric patients received ceftriaxone (CTRX) for bacterial infections.
- Clinical efficacy was high, with 20 out of 21 infected children showing excellent or good results.
- Reported side effects included diarrhea, elevated transaminases, and eosinophilia; pharmacokinetic data revealed mean serum half-lives of 6.16 and 5.13 hours for different dosages.
Impact:
- Provides evidence for the effective use of ceftriaxone in treating common pediatric bacterial infections.
- Offers valuable pharmacokinetic data to guide dosing and therapeutic monitoring in pediatric patients.
- Highlights the generally favorable safety profile of ceftriaxone in this age group.
Abstract:
Twenty-eight pediatric patients were treated with ceftriaxone (Ro 13-9904, CTRX) in the doses ranging from 8.75 to 25 mg/kg every 12 hours for 3.5 to 11.5 days, and the clinical efficacy and side effects were evaluated. Among the 21 children with bacterial infections including pneumonia, acute bronchitis, otitis media, tonsillitis and urinary tract infections, the results were excellent in 9, good in 11, and fair in 1 patient. Out of the 28 patients, 2 patients had diarrhea, 3 patients had slightly elevated serum concentrations of transaminases, and 2 patients showed eosinophilia. The serum concentrations of CTRX in 5 children ranged from 50.0 to 93.8 micrograms/ml (mean 75.0 micrograms/ml) at 15 minutes and from 10.2 to 15.6 micrograms/ml (mean 13.4 micrograms/ml at 6 hours after 10 mg/kg intravenous bolus injection of CTRX. The serum half-lives were from 2.61 to 8.30 hours (mean 6.16 hours), and urinary recovery rates were from 43.3 to 58.0% (mean 48.5%) during 0-6 hours and from 52.0 to 66.1% (mean 59.4%) during 0-12 hours. After 20 mg/kg intravenous bolus injection of CTRX in 4 children, the serum concentrations of CTRX were from 118.8 to 162.5 micrograms/ml (mean 139.1 micrograms/ml) at 15 minutes and from 18.0 to 21.1 micrograms/ml (mean 19.2 micrograms/ml) at 6 hours. The serum half-lives were 4.07 to 6.34 hours (mean 5.13 hours), and urinary recovery rates were 38.6 to 51.1% (mean 45.4%) during 0-6 hours and from 54.8 to 64.0% (mean 59.0%) during 0-12 hours. Patients with impairment of renal function were excluded from this pharmacokinetic study.