Label: VARENICLINE- varenicline tartrate tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 14, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Varenicline tablet is indicated for use as an aid to smoking cessation treatment.
  • 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 are provided additional advice and support. Provide ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Capsular, biconvex tablets: 0.5 mg (white to off-white, debossed with "VC" on one side and "0.5" on the other side) and 1 mg (light blue, debossed with "VC" on one side and "1" on the other ...
  • 4 CONTRAINDICATIONS
    Varenicline tablet is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Neuropsychiatric Adverse Events including Suicidality - Serious neuropsychiatric adverse events have been reported in patients being treated with varenicline tablets [see 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 ...
  • 7 DRUG INTERACTIONS
    Based on varenicline characteristics and clinical experience to date, varenicline tablets has no clinically meaningful pharmacokinetic drug interactions [see Clinical Pharmacology (12.3)]. 7.1 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see Data] ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Varenicline is not a controlled substance. 9.3 Dependence - Humans - Fewer than 1 out of 1,000 patients reported euphoria in clinical trials with varenicline tablets ...
  • 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 Clinical Pharmacology ...
  • 11 DESCRIPTION
    Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Varenicline binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholine receptors. The efficacy of varenicline tablets in smoking cessation is ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Lifetime carcinogenicity studies were performed in CD-1 mice and Sprague-Dawley rats. There was no evidence of a ...
  • 14 CLINICAL STUDIES
    The efficacy of varenicline tablets 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7182 - NDC: 50090-7182-0 56 TABLET, FILM COATED in a BOTTLE
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Medication Guide) Initiate Treatment and Continue to Attempt to Quit if Lapse - Instruct patients to set a date to quit smoking and to initiate varenicline tablets ...
  • MEDICATION GUIDE
    Varenicline (var EN I kleen) Tablets - What is the most important information I should know about varenicline tablets? When you try to quit smoking, with or without varenicline tablets ...
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  • INGREDIENTS AND APPEARANCE
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