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[Clinical and pharmacokinetic evaluations of meropenem in children]
1Department of Pediatrics, Aomori Prefectural Central Hospital.
Abstract:
Twenty-five children were treated with meropenem (MEPM, SM-7338) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 9 months to 11 years. Dose levels of MEPM ranged from 50.4 to 108 mg/kg/day for 4 to 8 days. The 25 patients included 11 pneumonia cases, 4 bronchitis, 6 tonsillitis, 3 urinary tract infections and 1 gingivitis, and they were evaluated for the clinical efficacy of MEPM. Results were excellent in 13 and good in 12 patients. No side effects nor abnormal clinical laboratory test results were observed. The pharmacokinetics of MEPM was studied in 7 patients with ages ranging from 9 to 15 years. The mean plasma peak concentration of MEPM in 5 patients was 36.7 micrograms/ml after dosing 10 mg/kg, and that of 2 patients was 70.0 micrograms/ml after administering 20 mg/kg. These data showed that plasma concentrations of drug depended on dose levels. Average half-life values for the 2 groups (10 and 20 mg/kg) were 0.83 and 0.85 hour, respectively. Urinary recovery rates for the 2 groups (10 and 20 mg/kg) were 64.3% and 81.3%, respectively, in the first 5 hours after administration.
Insights
Meropenem (MEPM) demonstrated excellent or good clinical efficacy in pediatric patients with various infections, showing no observed side effects. Pharmacokinetic studies confirmed dose-dependent plasma concentrations and rapid elimination.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Antimicrobial Therapy
Background:
- Meropenem (MEPM) is a broad-spectrum carbapenem antibiotic.
- Pediatric infections require effective and safe treatment options.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of meropenem in children.
- To assess the pharmacokinetics of meropenem in pediatric patients.
Main Methods:
- Clinical trial involving 25 children (9 months to 11 years) treated with MEPM (50.4–108 mg/kg/day for 4–8 days).
- Pharmacokinetic analysis in 7 pediatric patients (9–15 years) receiving 10 or 20 mg/kg MEPM.
- Assessment of clinical outcomes and laboratory tests for safety.
Main Results:
- Excellent efficacy in 13 patients and good efficacy in 12 patients across various infections (pneumonia, bronchitis, tonsillitis, UTI, gingivitis).
- No adverse side effects or abnormal clinical laboratory findings were reported.
- Dose-dependent plasma peak concentrations (36.7 µg/ml at 10 mg/kg, 70.0 µg/ml at 20 mg/kg) and short half-life (0.83–0.85 hours) were observed.
- High urinary recovery rates (64.3%–81.3% within 5 hours) indicated efficient renal excretion.
Conclusions:
- Meropenem is a safe and effective antibiotic for treating common pediatric infections.
- The pharmacokinetic profile of meropenem in children supports its therapeutic use.
- Further investigation into optimal dosing for specific pediatric conditions may be warranted.