CHANTIX
varenicline tartrate · KIT · Pfizer Laboratories Div Pfizer Inc
Chantix (varenicline tartrate) is a prescription medication used to help adults quit smoking by reducing cravings and blocking the rewarding effects of nicotine. It works by binding to nicotine receptors in the brain to decrease withdrawal symptoms and the urge to smoke.
Key Facts
- Brand Name
- CHANTIX
- Generic Name
- varenicline tartrate
- NDC Code (Product)
0069-0471- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA021928
- Marketing Start
- 05/10/2006
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CHANTIX is indicated for use as an aid to smoking cessation treatment. CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Begin CHANTIX dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment. ( 2.1 ) • Starting week: 0.5 mg once daily on days 1–3 and 0.5 mg twice daily on days 4–7. ( 2.1 ) • Continuing weeks: 1 mg twice daily for a total of 12 weeks. ( 2.1 ) • An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. ( 2.1 ) • Renal impairment: Reduce the dose in patients with severe renal impairment (estimated creatinine clearance <30 mL/min). ( 2.2 ) • Consider dose reduction for patients who cannot tolerate adverse effects. ( 2.1 ) • Another attempt at treatment is recommended for those who fail to stop smoking or relapse when factors contributing to the failed attempt have been addressed. ( 2.1 ) • Provide patients with appropriate educational materials and counseling to support the quit attempt. ( 2.1 ) 2.1 Usual Dosage for Adults Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. P…
Contraindications
4 CONTRAINDICATIONS CHANTIX is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX. History of serious hypersensitivity or skin reactions to CHANTIX. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Based on varenicline characteristics and clinical experience to date, CHANTIX has no clinically meaningful pharmacokinetic drug interactions [see Clinical Pharmacology (12.3) ]. • Other smoking cessation therapies: Safety and efficacy in combination with other smoking cessation therapies has not been established. Coadministration of varenicline and transdermal nicotine resulted in a high rate of discontinuation due to adverse events. ( 7.1 ) • Effect of smoking cessation: Pharmacokinetics or pharmacodynamics of certain drugs may be altered due to smoking cessation with CHANTIX, necessitating dose adjustment. ( 7.2 ) 7.1 Use With Other Drugs for Smoking Cessation Safety and efficacy of CHANTIX in combination with other smoking cessation therapies have not been studied. Bupropion : Varenicline (1 mg twice daily) did not alter the steady-state pharmacokinetics of bupropion (150 mg twice daily) in 46 smokers. The safety of the combination of bupropion and varenicline has not been established. Nicotine replacement therapy (NRT ) : Although co-administration of varenicline (1 mg twice daily) and transdermal nicotine (21 mg/day) for up to 12 days did not affect nicotin…
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 symptoms and suicidality [see Boxed Warning and Warnings and Precautions (5.1) ] • Seizures [see Warnings and Precautions (5.2) ] • Interaction with Alcohol [see Warnings and Precautions (5.3) ] • Accidental injury [see Warnings and Precautions (5.4) ] • Cardiovascular Events [see Warnings and Precautions (5.5) ] • Angioedema and hypersensitivity reactions [see Warnings and Precautions (5.6) ] • Serious skin reactions [see Warnings and Precautions (5.7) ] In the placebo-controlled premarketing studies, the most common adverse events associated with CHANTIX (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for CHANTIX, compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates that are higher than placebo for the most common adverse event…
Frequently Asked Questions
What is CHANTIX used for?
Chantix (varenicline tartrate) is a prescription medication used to help adults quit smoking by reducing cravings and blocking the rewarding effects of nicotine. It works by binding to nicotine receptors in the brain to decrease withdrawal symptoms and the urge to smoke.
Is CHANTIX a controlled substance?
CHANTIX is not classified as a controlled substance by the DEA.
What is the generic name for CHANTIX?
The generic name for CHANTIX is varenicline tartrate. There are 9 other brand versions of varenicline tartrate.
What is the NDC code for CHANTIX ?
The NDC (National Drug Code) for CHANTIX is 0069-0471, listed by Pfizer Laboratories Div Pfizer Inc.