Pharmacokinetic Study of Sulbactam and Ampicillin Administered Concomitantly by Intraarterial or Intravenous Infusion in the Newborn

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Abstract
The combination of sulbactam and ampicillin was administered to 16 newborn infants, 15preterm and one term, who required umbilical arterial or venous catheterization and prophylactic antibiotics. The aims were to determine an appropriate dosage regimen and to study the pharmacokinetics. Satisfactory plasma concentrations were achieved with administration of a bolus injection of 50 mg of each drug/kg every 12hr (mean concentrations: sulbactam, 110mg/liter; ampicillin, 87 mg/liter 3 hr after dosing; and sulbactam, 105and 135mg/liter; ampicillin, 320 and 310mg/liter 30min after dosing in two infants. Mean elimination half-lives were longer than those in adults (sulbactam, 7.9 hr; ampicillin, 9.4 hr), and urinary excretion over 12 hr varied considerably (range: sulbactam, 7%–91%; ampicillin, 5%–132%), rates reflecting the immature renal function in the newborn anti the relative oliguria characteristic of preterm infants with idiopathic respiratory distress syndrome. There was little evidence of accumulation of either drug, and both were well tolerated. This combination and dosage should be suitable for a trial of therapy for infection in the newborn.

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