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CHANTIX® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

CHANTIX is indicated for use as an aid to smoking cessation treatment.

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2 DOSAGE AND ADMINISTRATION

2.1 Usual Dosage for Adults

Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who...

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3 DOSAGE FORMS AND STRENGTHS

Capsular, biconvex tablets: 0.5 mg (white to off-white, debossed with "Pfizer" on one side and "CHX 0.5" on the other side) and 1 mg (light blue, debossed with "...

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4 CONTRAINDICATIONS

CHANTIX is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX.

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5 WARNINGS AND PRECAUTIONS

5.1 Neuropsychiatric Adverse Events including Suicidality

Serious neuropsychiatric adverse events have been reported in patients being...

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6 ADVERSE REACTIONS

The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling:

  • Neuropsychiatric Adverse...
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7 DRUG INTERACTIONS

Based on varenicline characteristics and clinical experience to date, CHANTIX has no clinically meaningful pharmacokinetic drug interactions [see

7.1 Use with Other Drugs for...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data have not...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Varenicline is not a controlled substance.

9.3...

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10 OVERDOSAGE

In case of overdose, standard supportive measures should be instituted as required.

Varenicline has been shown to be dialyzed in patients with end-stage renal disease [see...

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11 DESCRIPTION

CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Varenicline binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholine receptors. The...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

The efficacy of CHANTIX in smoking cessation was demonstrated in six clinical trials in which a total of 3659 chronic cigarette smokers (≥10 cigarettes per day) were treated with CHANTIX. In all clinical...

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16 HOW SUPPLIED/STORAGE AND HANDLING

CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one...

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...
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised Feb 2019    
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This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.

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