HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TYGACIL safely and effectively. See full prescribing information for TYGACIL.
TYGACIL® (tigecycline) FOR INJECTION for intravenous use
Initial U.S. Approval: 2005
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
RECENT MAJOR CHANGES
Indications and Usage 3/2009
    Community-acquired bacterial pneumonia (1.3)  
Warnings and Precautions  
     All-Cause Mortality (5.1) 5/2010
     Hepatic Effects (5.3) 9/2008
     Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia (5.4) 5/2010
INDICATIONS AND USAGE
TYGACIL is a tetracycline class antibacterial indicated in patients 18 years of age and older for:
Complicated skin and skin structure infections (1.1)
Complicated intra-abdominal infections (1.2)
Community-acquired bacterial pneumonia (1.3)
DOSAGE AND ADMINISTRATION
Initial dose of 100 mg, followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. (2.1)
Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. (2.2)
DOSAGE FORMS AND STRENGTHS
50 mg lyophilized powder for reconstitution in a single-dose 5 mL vial. (3)
CONTRAINDICATIONS
Known hypersensitivity to tigecycline. (4)
WARNINGS AND PRECAUTIONS
An increase in all-cause mortality has been observed across phase 3 and 4 clinical studies in TYGACIL treated patients versus comparator. The cause of this increase has not been established. This increase should be considered when selecting among treatment options. (5.1)
Anaphylaxis/anaphylactoid reactions have been reported with TYGACIL, and may be life-threatening. Exercise caution in patients with known hypersensitivity to tetracyclines. (5.2)
Hepatic dysfunction and liver failure have been reported with TYGACIL. (5.3)
Lower cure rates and higher mortality were seen when patients with ventilator-associated pneumonia were treated with TYGACIL. (5.4)
TYGACIL may cause fetal harm when administered to a pregnant woman. (5.5)
The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. (5.6)
Clostridium difficile associated diarrhea: eva luate if diarrhea occurs. (5.7)
ADVERSE REACTIONS
The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Suitable anticoagulation test should be monitored if TYGACIL is administered to patients receiving warfarin. (7.1)
USE IN SPECIFIC POPULATIONS
Pediatrics: Use in patients under 18 years of age is not recommended. (8.4)
See 17 for PATIENT COUNSELING INFORMATION 
Revised: 05/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
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