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PHARMACOKINETICS

Pharmacokinetics of Ertapenem in Patients With Varying Degrees of Renal Insufficiency and in Patients on Hemodialysis

Goutam C. Mistry, MSc, Anup K. Majumdar, PhD, Suzanne Swan, MD, Domenic Sica, MD, Alison Fisher, PhD, Yang Xu, PhD, Michael Hesney, MS, Liwen Xi, PhD, John A. Wagner, MD, PhD and Paul J. Deutsch, MD, PhD

From the Department of Clinical Pharmacology, Rahway, New Jersey (Mr Mistry, Dr Wagner, Dr Deutsch); the Department of Drug Metabolism, West Point, Pennsylvania (Dr Majumdar, Dr Fisher, Dr Xu); the Department of Clinical Biostatistics, Blue Bell, Pennsylvania (Mr Hesney, Dr Xi); Merck Research Laboratories, Total Renal Research, Minneapolis, Minnesota (Dr Swan); and the Department of Clinical Pharmacology and Hypertension, Medical College of Virginia, Richmond, Virginia (Dr Sica). This study was supported by Merck & Co Inc.

Ertapenem is a parenteral ß-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 ~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.

Key Words: Ertapenem • pharmacokinetics • renal insufficiency

Address for reprints: Goutam C. Mistry, MSc, Department of Clinical Pharmacology, Merck Research Laboratories, RY34-A536, Rahway, NJ 07065, e-mail: goutam_mistry{at}merck.com.




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[Abstract] [Full Text] [PDF]


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