Pharmacokinetics of ampicillin and sulbactam in pediatric patients

Intravenous ampicillin-sulbactam is effective in the treatment of various i nfections in adults, but little is known about the pharmacokinetics (PK) of ampicillin-sulbactam in children. The objective of this study was to deter mine the PK of ampicillin and sulbactam in pediatric patients with intra-ab dominal infection, skin and/or skin structure infection, or periorbital-pre septal and facial cellulitis. Intravenous ampicillin and sulbactam (2:1), 4 0 to 80 mg/kg of body weight, were given every 6 h for 2 to 6 days to 28 pe diatric patients. The ages ranged from 1 to 6 years for 10 patients, 6.1 to 10 years for 9 patients, and 10.1 to 12 years for 9 patients, Multiple blo od samples were obtained and analyzed for ampicillin and sulbactam in plasm a and serum by highperformance liquid chromatography. The mean maximum conc entration of drug in serum ranged from 177 to 200 mu g/ml for ampicillin an d 82 to 102 mu g/ml for sulbactam in the three age groups. The mean total c learance, steady-state distribution volume, and half-life were 4.76 ml/min/ kg, 0.32 liter/kg, and 0.77 h, respectively, for ampicillin and 4.95 ml/min /kg, 0.34 liter/kg, and 0.81 h, respectively, for sulbactam. Dose or gender did not affect the PK of ampicillin or sulbactam. The PK of ampicillin and sulbactam in these patients were comparable to those reported in adults. T he combination was well tolerated in pediatric patients.