University of Pennsylvania Medical Center Guidelines for Antibiotic Use

Guidelines for the Use of Tigecycline (Tygacil®)

The Antibiotic Subcommittee of the Pharmacy & Therapeutics Committee has reviewed and discussed all of the clinical, pharmacokinetic, drug interaction, and safety data relating to the new glycylcycline antibiotic, tigecycline. One major randomized, multicenter, double-blind, comparative trial demonstrated that tigecycline was as safe and efficacious as vancomycin + aztreonam combination in treating patients with complicated skin and skin-structure infections (cSSSI).1 Another major randomized, multicenter, double-blind, comparative trial demonstrated that tigecycline was as safe and efficacious as imipenem-cilastatin in treating patients with complicated intra-abdominal infections.2 However, six patients in the tigecycline group who presented with intestinal perforations developed sepsis/septic shock (compared with 2 patients in the imipenem-cilastatin group).2 Therefore, tigecycline should NOT be used as monotherapy in patients with complicated intra-abdominal infections caused by bowel perforation. Tigecycline has in vitro and in vivo activity against a broad spectrum of bacterial pathogens and no cross resistance has been observed between tigecycline and other antibiotics.3 The most common adverse reactions associated with tigecycline therapy were nausea (30%) and vomiting (20%).3

In order to decrease the risk of treatment failure and preserve tigecycline for treatment of multi-drug resistant gram-negative pathogens, the following are criteria for the use of tigecycline at the Hospital of the University of Pennsylvania:

Tigecycline dosing:

  Usual Dose Renal Failure Severe Hepatic Impairment (Child Pugh C)
Loading Dose 100 mg IV x1 no adjustment needed 100 mg IV x1
Maintenance Dose 50 mg IV q12h no adjustment needed 25 mg IV q12h

References:

1. Ellis-Grosse EJ, Babinchak T, Dartois N, Rose G, Loh E. The Efficacy and Safety of Tigecycline in the Treatment of Skin and Skin-Structure Infections: Results of 2 Double-Blind Phase 3 Comparison Studies with Vancomycin-Aztreonam. Clinical Infectious Diseases. 2005; 41:S341-53.

2. Babinchak T, Ellis-Grosse E, Dartois N, Rose GM, Loh E. The Efficacy and Safety of Tigecycline for the Treatment of Complicated Intra-Abdominal Infections: Analysis of Pooled Clinical Trial Data. Clinical Infectious Diseases. 2005; 41:S354-67.

3. Tygacil™ [tigecycline] package insert. Philadelphia, PA: Wyeth Pharmaceuticals Inc, June 2005.

Written by Shawn Binkley 7/10/06

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