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CHANTIX®Index Section (varenicline tartrate)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Usual Dosage for Adults

2.2 Dosage in Special Populations

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Neuropsychiatric Adverse Events including Suicidality

5.2 Seizures

5.3 Interaction with Alcohol

5.4 Accidental Injury

5.5 Cardiovascular Events

5.6 Somnambulism

5.7 Angioedema and Hypersensitivity Reactions

5.8 Serious Skin Reactions

5.9 Nausea

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Use with Other Drugs for Smoking Cessation

7.2 Effect of Smoking Cessation on Other Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Initiation of Abstinence

14.2 Urge to Smoke

14.3 Long-Term Abstinence

14.4 Alternative Instructions for Setting a Quit Date

14.5 Gradual Approach to Quitting Smoking

14.6 Re-Treatment Study

14.7 Subjects with Chronic Obstructive Pulmonary Disease

14.8 Subjects with Cardiovascular Disease and Other Cardiovascular Analyses

14.9 Subjects with Major Depressive Disorder

14.10 Postmarketing Neuropsychiatric Safety Outcome Trial

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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