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

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

• Anaphylaxis/anaphylactoid reactions have been reported with TYGACIL, and may be life-threatening. Exercise caution in patients with known hypersensitivity to tetracyclines. (5.1)
• Hepatic dysfunction and liver failure have been reported with TYGACIL. (5.2)
• Lower cure rates and higher mortality were seen when patients with ventilator-associated pneumonia were treated with TYGACIL. (5.3)
• TYGACIL may cause fetal harm when administered to a pregnant woman. (5.4)
• The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. (5.5)
• Clostridium difficile associated diarrhea: eva luate if diarrhea occurs. (5.6)

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)

1 INDICATIONS AND USAGE

1.1 Complicated Skin and Skin Structure Infections

1.2 Complicated Intra-abdominal Infections

1.3 Community-Acquired Bacterial Pneumonia

1.4 Usage

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

2.2 Patients With Hepatic Impairment

2.3 Preparation and Handling

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylaxis/Anaphylactoid Reactions

5.2 Hepatic Effects

5.3 Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia

5.4 Use During Pregnancy

5.5 Tooth Development

5.6 Clostridium difficile Associated Diarrhea

5.7 Patients With Intestinal Perforation

5.8 Tetracycline-Class Effects

5.9 Superinfection

5.10 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 Warfarin

7.2 Oral Contraceptives

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Complicated Skin and Skin Structure Infections

14.2 Complicated Intra-abdominal Infections

14.3 Community-Acquired Bacterial Pneumonia

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION