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Single-dose pharmacokinetics of intravenous sulbactam in pediatric patients
Insights
This study investigated sulbactam pharmacokinetics in pediatric patients. Results support using intravenous sulbactam every 6-8 hours for children receiving beta-lactam therapy.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Clinical Pharmacy
Background:
- Sulbactam is an adjunct to beta-lactam antibiotics.
- Pediatric pharmacokinetics of sulbactam require further investigation.
Purpose of the Study:
- To determine the pharmacokinetics of intravenous sulbactam in pediatric patients aged 2 to 14 years.
- To evaluate the safety and efficacy of sulbactam dosing regimens in children.
Main Methods:
- Intravenous administration of single sulbactam doses (12.5 or 25 mg/kg) over 3 minutes.
- Pharmacokinetic parameter analysis using noncompartmental and compartmental models.
- Urine sample analysis for drug excretion.
Main Results:
- Linear pharmacokinetics observed within the studied concentration range.
- Mean terminal-phase half-life: 1.75 hr; total plasma clearance: 180 ml/min/1.73 m2; apparent volume of distribution: 340 ml/kg.
- 70%-80% of the dose excreted unchanged in urine; increased clearance and volume of distribution in cystic fibrosis patients.
Conclusions:
- The findings support the intravenous administration of 12.5-25 mg/kg sulbactam every 6-8 hours in pediatric patients.
- This dosing regimen may be adequate for sulbactam as an adjunct to beta-lactam therapy for bacterial infections in children.
Abstract:
The pharmacokinetics of intravenously administered sulbactam were studied in 17 pediatric patients two to 14 years of age. Single doses of 12.5 or 25 mg/kg were infused over 3 min, and in previously healthy children, mean peak plasma concentrations 5 min after dosing were 71 and 163 micrograms/ml, respectively. Noncompartmental and compartmental calculations resulted in similar pharmacokinetic parameters. Linear pharmacokinetics were found in the concentration range studied. The mean terminal-phase half-life was 1.75 hr, the mean total plasma clearance was 180 ml/min per 1.73 m2, and the mean apparent volume of distribution was 340 ml/kg. Approximately 70%-80% of an intravenous dose was excreted unchanged in the urine. In children with cystic fibrosis, both total plasma clearance and apparent volume of distribution were significantly increased. The data support the intravenous administration of 12.5-25 mg of sulbactam/kg every 6 to 8 hr for assessing the adequacy of this drug as an adjunct to beta-lactam therapy for various bacterial infections in children.