Pharmacokinetics of ertapenem in patients with varying degrees of renal insufficiency and in patients on hemodialysis

J Clin Pharmacol. 2006 Oct;46(10):1128-38. doi: 10.1177/0091270006291839.

Abstract

Ertapenem is a parenteral beta-lactam carbapenem antibiotic. This open-label study examined the pharmacokinetics of single 1-g intravenous doses of ertapenem, administered over 30 minutes, in patients with mild, moderate, and advanced renal insufficiency (RI) and in patients with end-stage renal disease (ESRD) requiring hemodialysis. Pharmacokinetics were compared with historical controls pooled across healthy young and elderly subjects. Area under the concentration-time curve from time zero to infinity increased 7% in mild, 53% in moderate, 158% in advanced RI, and 192% in ESRD; end of infusion concentration changed minimally; half-life was 4.5 hours in the historical control group and 4.4, 6.1, 10.6, and 14.1 hours in mild RI, moderate RI, advanced RI, and ESRD, respectively. Hemodialysis cleared approximately 30% of the dose. The recommended dose in mild to moderate RI and after hemodialysis is unchanged at 1 g daily; and in advanced RI and ESRD is reduced to 0.5 g daily. If the daily dose is given 6 hours prior to hemodialysis, a supplementary 150-mg dose (30% of the daily dose) is recommended postdialysis.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Alanine Transaminase / blood
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / pharmacokinetics
  • Area Under Curve
  • Aspartate Aminotransferases / blood
  • Drug Administration Schedule
  • Ertapenem
  • Female
  • Half-Life
  • Humans
  • Infusions, Intravenous
  • Kidney / metabolism
  • Kidney Failure, Chronic / metabolism
  • Kidney Failure, Chronic / therapy
  • Male
  • Metabolic Clearance Rate
  • Middle Aged
  • Renal Dialysis*
  • Renal Insufficiency / metabolism
  • Renal Insufficiency / therapy*
  • Time Factors
  • beta-Lactams / administration & dosage
  • beta-Lactams / pharmacokinetics*

Substances

  • Anti-Bacterial Agents
  • beta-Lactams
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Ertapenem