varenicline tartrate 1 mg/1
varenicline tartrate · TABLET, FILM COATED · Micro Labs Limited
Varenicline tartrate is a prescription medication taken by mouth that helps people quit smoking by reducing cravings and blocking the rewarding effects of nicotine. It comes as a 1 mg coated tablet.
Key Facts
- Brand Name
- varenicline tartrate
- Generic Name
- varenicline tartrate
- NDC Code (Product)
42571-460- Manufacturer
- Micro Labs Limited
- Strength
- 1 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218302
- Marketing Start
- 12/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Varenicline tablets is indicated for use as an aid to smoking cessation treatment. Varenicline tablets 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 varenicline tablets dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin varenicline tablets 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 ) Consider a gradual approach to quitting smoking with varenicline tablets for patients who are sure that they are not able or willing to quit abruptly. Patients should begin varenicline tablets dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue treatment for an additional 12 weeks, for a total of 24 weeks. ( 2.1 ) Severe Renal Impairment (estimated creatinine clearance less than 30 mL/min): Begin with 0.5 mg once daily and titrate to 0.5 mg twice daily. For patients with end-stage renal disease u…
Contraindications
4 CONTRAINDICATIONS Varenicline tablets is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. History of serious hypersensitivity or skin reactions to varenicline tablets.( 4 )
Drug Interactions
7 DRUG INTERACTIONS Based on varenicline characteristics and clinical experience to date, varenicline 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 on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment. ( 7.2 ) 7.1 Use with Other Drugs for Smoking Cessation Safety and efficacy of varenicline 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 n…
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 Events including Suicidality [see 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)] Somnambulism [see Warnings and Precautions (5.6)] Angioedema and Hypersensitivity Reactions [see Warnings and Precautions (5.7)] Serious Skin Reactions [see Warnings and Precautions (5.8)] In the placebo-controlled premarketing studies, the most common adverse events associated with varenicline (>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 varenicline, compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates that are higher than placebo fo…
Frequently Asked Questions
What is varenicline tartrate used for?
Varenicline tartrate is a prescription medication taken by mouth that helps people quit smoking by reducing cravings and blocking the rewarding effects of nicotine. It comes as a 1 mg coated tablet.
Is varenicline tartrate a controlled substance?
varenicline tartrate is not classified as a controlled substance by the DEA.
What is the generic name for varenicline tartrate?
The generic name for varenicline tartrate is varenicline tartrate. There are 11 other brand versions of varenicline tartrate.
What is the NDC code for varenicline tartrate 1 mg/1?
The NDC (National Drug Code) for varenicline tartrate 1 mg/1 is 42571-460, listed by Micro Labs Limited.