Single-Dose Pharmacokinetics of Intravenous Sulbactam in Pediatric Patients

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 µg/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 1.75hr, 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 weresignificantly 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 β-lactam therapy for various bacterial infections in children.