Label: VENLAFAXINE HYDROCHLORIDE capsule, extended release

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

Drug Label Information

Updated March 2, 2021

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    WARNING: SUICIDAL THOUGHTS AND BEHAVIORS - Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did ...

    WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

    Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].

    In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].

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  • 1 INDICATIONS AND USAGE
    1.1 Major Depressive Disorder - Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three ...
  • 2 DOSAGE AND ADMINISTRATION
    Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [see ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Venlafaxine Hydrochloride Extended-Release Capsules, USP are available in the following strengths:   Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg are white to off-white ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation - 4.2 Concomitant Use with Monoamine Oxidase Inhibitors ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults - Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity [see Contraindications (4.1) ] Suicidal Thoughts and Behaviors in Children ...
  • 7 DRUG INTERACTIONS
    7.1 Central Nervous System (CNS)-Active Drugs - The risk of using venlafaxine in combination with other CNS-active drugs has not been systematically evaluated. Consequently, caution is advised ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects – Pregnancy Category C - Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Venlafaxine hydrochloride extended-release capsule is not a controlled substance. 9.2 Abuse - While venlafaxine has not been systematically studied in clinical ...
  • 10 OVERDOSAGE
    10.1 Human Experience - During the premarketing evaluations of venlafaxine hydrochloride extended-release capsules (for MDD, GAD, SAD, and PD) and venlafaxine hydrochloride tablets (for MDD) ...
  • 11 DESCRIPTION
    Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The exact mechanism of the antidepressant action of venlafaxine in humans is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Tumors were not increased by venlafaxine treatment in mice or rats. Venlafaxine was given by oral gavage to mice for ...
  • 14 CLINICAL STUDIES
    14.1 Major Depressive Disorder - The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for Major Depressive Disorder (MDD) was established in two placebo-controlled ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-5145 - NDC: 50090-5145-0 30 CAPSULE, EXTENDED RELEASE in a BOTTLE
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Medication Guide). Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India - Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 11/20
  • MEDICATION GUIDE
    Medication Guide - Venlafaxine Hydrochloride -  (ven" la fax' een hye" droe klor' ide) Extended-Release Capsules, USP - Read the Medication Guide that comes with venlafaxine hydrochloride ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India - Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 07/20
  • VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
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  • INGREDIENTS AND APPEARANCE
    Product Information