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:
|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|
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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