Related Experiment Videos
[Studies on imipenem/cilastatin sodium in the field of pediatrics]
Insights
Pediatric pharmacokinetic studies of imipenem/cilastatin sodium showed similar absorption and excretion profiles to adults. Clinical trials demonstrated 100% efficacy in treating various pediatric infections.
Area of Science:
- Pharmacology
- Pediatrics
- Infectious Diseases
Context:
- Imipenem/cilastatin sodium is a combination antibiotic used for serious infections.
- Pediatric dosing and pharmacokinetics require specific evaluation.
- Understanding drug behavior in children is crucial for effective treatment.
Purpose:
- To evaluate the pharmacokinetics and clinical efficacy of imipenem/cilastatin sodium in pediatric patients.
- To compare pediatric pharmacokinetic data with existing adult data.
- To assess the safety and effectiveness of imipenem/cilastatin sodium in treating pediatric infections.
Summary:
- Pharmacokinetic studies in 7 children (4-11 years) showed imipenem and cilastatin sodium levels and excretion patterns similar to adults.
- Clinical evaluation in 22 pediatric patients with various infections (pneumonia, pyelonephritis, etc.) resulted in a 100% efficacy rate.
- Adverse reactions were also monitored during the clinical treatment period.
Impact:
- Provides essential pharmacokinetic data for pediatric dosing of imipenem/cilastatin sodium.
- Confirms the clinical effectiveness and safety of imipenem/cilastatin sodium in pediatric populations.
- Supports the use of this antibiotic combination in treating a range of pediatric bacterial infections.
Abstract:
Pharmacokinetic and clinical studies on imipenem (MK-0787)/cilastatin sodium (MK-0791), a combined drug of carbapenem antibiotics (MK-0787) and renal depeptidase inhibitor (MK-0791) in a 1:1 ratio, were performed in the field of pediatrics. Absorption and excretion Serum levels and urinary excretion of MK-0787/MK-0791 were determined in 7 children aged 4 to 11 years. Four cases were administered with a single dose of MK-0787/MK-0791 at 10 mg/10 mg/kg by intravenous drip infusion and the other 3 cases were given a single dose of 20 mg/20 mg/kg. Serum concentrations of MK-0787 reached their peaks at the end of drip infusion where the mean level was 17.5 +/- 1.0 micrograms/ml for the group given 10 mg/10 mg/kg, and 43.6 +/- 2.1 micrograms/ml for the group given 20 mg/20 mg/kg. Concentrations decreased with half-lives of 0.82 +/- 0.10 hour and 0.74 +/- 0.04 hour for the low and high doses, respectively, and serum levels at 6 hours after administration were 0.3 +/- 0.1 microgram/ml and 0.4 +/- 0.1 microgram/ml, respectively. Peak concentrations of MK-0791 were 22.6 +/- 4.8 micrograms/ml in the 10 mg/10 mg/kg group and 52.9 +/- 4.7 micrograms/ml in the 20 mg/20 mg/kg group at the end of the drip infusion. Half-lives were 0.56 +/- 0.17 hour and 0.46 +/- 0.11 hour for the 2 doses, respectively while MK-0791 levels were below detection limit at 6 hours after administration. Mean urinary recovery rates in 6 hours after administration were 54.0 +/- 15.3% and 49.3 +/- 7.8% for MK-0787 and MK-0791, respectively, in the group of 10 mg/10 mg/kg, and 62.0 +/- 7.4% and 65.3 +/- 9.2%, respectively, in the group of 20 mg/20 mg/kg. These results showed that pharmacokinetics of MK-0787 and MK-0791 in children were similar to that in adults. Clinical study MK-0787/MK-0791 was used for treatment in a total of 22 pediatric patients to evaluate clinical effectiveness, bacteriological efficacy and adverse reactions. Each of patients was treated 3 or 4 times per day at a single dose of 11.4-22.8 mg/kg (of MK-0787). Duration of treatment ranged from 2.5 to 18 days and total doses ranged from 1.36 to 19.92 g. Clinical efficacy in cases including 2 with acute purulent tonsillitis, 1 with acute purulent otitis media, 9 with acute pneumonia, 1 with pythorax, 3 with acute purulent lymphadenitis, and 6 with acute pyelonephritis were judged excellent in 20 cases and good in 2 cases; an efficacy rate of 100%.(ABSTRACT TRUNCATED AT 400 WORDS)