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TYGACIL®Index Section (tigecycline)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ALL-CAUSE MORTALITY

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 Limitations of Use

1.5 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Adult Dosage

2.2 Dosage in Patients With Hepatic Impairment

2.3 Dosage in Pediatric Patients

2.4 Monitoring of Blood Coagulation Parameters

2.5 Preparation and Administration

2.6 Drug Compatibilities

2.7 Drug Incompatibilities

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 All-Cause Mortality

5.2 Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia

5.3 Anaphylactic Reactions

5.4 Hepatic Adverse Effects

5.5 Pancreatitis

5.6 Monitoring of Blood Coagulation Parameters

5.7 Tooth Discoloration and Enamel Hypoplasia

5.8 Inhibition of Bone Growth

5.9 Clostridioides difficile-Associated Diarrhea

5.10 Sepsis/Septic Shock in Patients With Intestinal Perforation

5.11 Tetracycline-Class Adverse Effects

5.12 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 Calcineurin Inhibitors

7.3 Oral Contraceptives

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

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

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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