Label: VARENICLINE- varenicline tartrate tablet, film coated
VARENICLINE- varenicline tartrate kit

  • NDC Code(s): 72603-476-01, 72603-477-01, 72603-478-01
  • Packager: NorthStar RxLLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 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 ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Varenicline tablets are 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
    Varenicline tablets 0.5 mg:Pink, capsular, biconvex, film coated tablets debossed with "H" on one side and "V23" on the other side. Varenicline tablets 1 mg:Yellow, capsular, biconvex, film ...
  • 4 CONTRAINDICATIONS
    Varenicline tablets are 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 - [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 ...
  • 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)] ...
  • 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 ...
  • 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. At ...
  • 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 ...
  • 11 DESCRIPTION
    Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2nicotinic acetylcholine receptor subtypes. Varenicline, as ...
  • 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 in smoking cessation is believed to ...
  • 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 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 varenicline ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Varenicline tablets are supplied for oral administration in two strengths and are supplied in the following package configurations: Varenicline tablets 0.5 mg:Pink, capsular, biconvex, film ...
  • 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 ...
  • MEDICATION GUIDE
    Varenicline Tablets - (ver EN e kleen) What is the most important information I should know about varenicline tablets? When you try to quit smoking, with or without ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Varenicline Tablets-0.5 mg Bottle Label - Varenicline Tablets-1 mg Bottle Label - Varenicline Tablets- 0.5 mg/1 mg Starting Blister Card - Varenicline Tablets-0.5 mg/1 mg Starting Month ...
  • INGREDIENTS AND APPEARANCE
    Product Information