Label: VENLAFAXINE tablet, coated

  • NDC Code(s): 72241-075-04, 72241-075-11, 72241-075-22, 72241-076-04, view more
  • Packager: Modavar Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 30, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for VENLAFAXINE EXTENDED-RELEASE ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    BOXED WARNING


    WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS




    Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine extended-release tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine extended-release tablets are not approved for use in pediatric patients. [See Warnings and Precautions (5.1) and Patient Counseling Information (17.1)]


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  • 1 INDICATIONS AND USAGE
    1.1 Major Depressive Disorder - Venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both ...
  • 2 DOSAGE AND ADMINISTRATION
    Venlafaxine extended-release tablets should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each tablet should be ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Venlafaxine extended-release tablets are available as: 75 mg tablets (white to off - white, round, coated tablets imprinted with black ink “C46” on one side and plain on the other side) 150 ...
  • 4 CONTRAINDICATIONS
    4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOI’s intended to treat psychiatric disorders with venlafaxine extended-release tablets or within 7 days of stopping treatment with ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Clinical Worsening and Suicide Risk - Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Studies Experience - Data Sources - The information included in subsection “Adverse Findings Observed in Short-Term, Placebo- Controlled Studies with Venlafaxine Hydrochloride ...
  • 7 DRUG INTERACTIONS
    7.1 Alcohol - A single dose of ethanol (0.5 g/kg) had no effect on the pharmacokinetics of venlafaxine or O-desmethylvenlafaxine (ODV) when venlafaxine was administered at 150 mg/day in 15 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Venlafaxine extended-release tablets (venlafaxine hydrochloride) are not a controlled substance. 9.2 Abuse - While venlafaxine has not been systematically studied ...
  • 10 OVERDOSAGE
    10.1 Human Experience - Among the patients included in the premarketing evaluation of venlafaxine hydrochloride extended-release capsules, there were 2 reports of acute overdosage with ...
  • 11 DESCRIPTION
    Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the CNS ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Venlafaxine was given by oral gavage to mice for 18 months at doses up to 120 mg/kg per day, which was 1.7 times ...
  • 14 CLINICAL STUDIES
    14.1 Major Depressive Disorder - The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for major depressive disorder was established in two placebo-controlled ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Venlafaxine extended-release tablets 75 mg are white to off - white, round, coated tablets imprinted with black ink “C46” on one side and plain on the other side. They are supplied as ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Prescribers or other health professionals should inform patients, their families, and their caregivers about ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Venlafaxine Extended-Release Tablets 75 mg - Container Label 30 Tablets - NDC 72241-075-22 - Venlafaxine Extended-Release Tablets - 75 mg - Pharmacist: Dispense the accompanying Medication Guide to ...
  • INGREDIENTS AND APPEARANCE
    Product Information