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CHANTIX®(varenicline tartrate)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
CHANTIX® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
CHANTIX is indicated for use as an aid to smoking cessation treatment.
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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
CHANTIX is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX.
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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
7 DRUG INTERACTIONS
Based on varenicline characteristics and clinical experience to date, CHANTIX has no clinically meaningful pharmacokinetic drug interactions [see Clinical...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data have not...
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Drug Abuse and Dependence
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Varenicline is not a controlled substance.
9.3...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
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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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised Feb 2019 | |||||
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.