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[Pharmacokinetic and clinical studies on cefmenoxime in newborn infants]
1Department of Pediatrics, School of Medicine, Showa University.
Insights
Pharmacokinetic studies of cefmenoxime (CMX) in infants show dose-dependent serum concentrations and acceptable safety profiles. CMX demonstrated excellent clinical efficacy in treating various bacterial infections in infants.
Area of Science:
- Pharmacology
- Pediatrics
- Infectious Diseases
Context:
- Neonatal and infant populations present unique pharmacokinetic challenges.
- Bacterial infections in infants require safe and effective antimicrobial agents.
- Cefmenoxime (CMX) is a third-generation cephalosporin antibiotic.
Purpose:
- To evaluate the pharmacokinetics and clinical efficacy of cefmenoxime (CMX) in infants.
- To determine optimal dosing strategies for CMX in this age group.
- To assess the safety and tolerability of CMX in infants.
Summary:
- Pharmacokinetic analysis revealed dose-dependent serum concentrations of CMX following intravenous administration in infants.
- Urinary recovery rates varied with infant age, suggesting developmental changes in drug excretion.
- CMX demonstrated excellent clinical efficacy in treating serious bacterial infections like pneumonia and septicemia in infants, with no observed adverse effects.
Impact:
- Provides crucial pharmacokinetic data to guide CMX dosing in infant populations.
- Highlights the safety and efficacy of CMX for treating bacterial infections in neonates and infants.
- Supports the use of CMX as a therapeutic option for pediatric infectious diseases.
Abstract:
Pharmacokinetic and clinical studies on cefmenoxime (CMX) were performed in infants given by the drug intravenous drip infusion or one shot intravenous injection. The results obtained are summarized as follows. 1. Serum concentrations of CMX in infants given CMX at 10 mg/kg by intravenous drip infusion peaked at 12.0 to 26.5 micrograms/ml at the termination of the administration, and the levels were 8.62 to 26.3 micrograms/ml in 1 hour after dosing. Half-lives were 2.9 to 3.8 hours. 2. Serum concentrations of CMX in infants given the drug at 20 mg/kg by the same manner for 30 minutes to 1 hour peaked at 40.8 to 74.3 micrograms/ml at the termination of the administration, and drug levels decreased to 17.6 to 45.4 micrograms/ml in 1 hour after dosing. Half-lives were 0.8 to 2.7 hours. Those of CMX in infants given the same dose by one shot intravenous injection peaked at 61.7 to 90.6 micrograms/ml immediately after dosing, and decreased to 22.3 to 48.2 micrograms/ml at 1 hour. Half-lives were 1.2 to 2.7 hours. 3. As described above, dose-response was observed between the doses of 10 mg/kg and 20 mg/kg. 4. Urinary recovery rates were 2.6 to 47.7% during the first 6-8 hours in most of 1 to 2 day-old infants, and 17.6 to 72.4% in most of 5 day-old or older ones. 5. Twelve infants with various bacterial infections were given CMX by intravenous injection or drip infusion. Clinical efficacies of CMX were excellent or good in all the 9 infants with pneumonia, septicemia, amniotic fluid-aspiration syndrome or intra-placental infection etc., while 3 cases were excluded: 1 each with congenital syphilis (0 day old), acute bronchitis (56 days old) and whooping cough (54 days old). 6. Dosages of CMX used in the present study were 33 to 79 mg/kg/day, and durations of treatment ranged from 4 to 13 days. No abnormal laboratory test values were observed. Moreover, neither systemic nor local adverse effects attributable to CMX were encountered in any of the infants.