VENLAFAXINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Available from:

Alembic Pharmaceuticals Inc.

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effica

Product summary:

Venlafaxine Tablets, USP are available containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine. 25 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with ‘175’ on one side and breakline on other side. NDC 62332-008-30 bottle of 30 tablets. NDC 62332-008-31 bottle of 100 tablets. NDC 62332-008-91 bottle of 1000 tablets. 37.5 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with ‘176’ on one side and breakline on other side. NDC 62332-009-30 bottle of 30 tablets. NDC 62332-009-31 bottle of 100 tablets. NDC 62332-009-91 bottle of 1000 tablets. 50 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with ‘L177’ on one side and breakline on other side. NDC 62332-010-30 bottle of 30 tablets. NDC 62332-010-31 bottle of 100 tablets. NDC 62332-010-91 bottle of 1000 tablets. 75 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with ‘L178’ on one side and breakline on other side. NDC 62332-011-30 bottle of 30 tablets. NDC 62332-011-31 bottle of 100 tablets. NDC 62332-011-91 bottle of 1000 tablets. 100 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with ‘L179’ on one side and breakline on other side. NDC 62332-012-30 bottle of 30 tablets. NDC 62332-012-31 bottle of 100 tablets. NDC 62332-012-91 bottle of 1000 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP. * Different strengths of the drug product mentioned in the package insert are based on Venlafaxine base. Medication Guide available at http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 08/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE - VENLAFAXINE TABLET
Alembic Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Venlafaxine
(ven-la-fax-een) Tablets, USP
Read the Medication Guide that comes with venlafaxine tablets before
you start taking it and each time
you get a refill. There may be new information. This Medication Guide
does not take the place of talking
to your healthcare provider about your medical condition or treatment.
Talk with your healthcare provider
if there is something you do not understand or want to learn more
about.
What is the most important information I should know about venlafaxine
tablets?
Venlafaxine tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
• Venlafaxine tablets and other antidepressant medicines may
increase suicidal thoughts or actions in
some children, teenagers, or young adults within the first few months
of treatment or when the dose is
changed.
• Depression or other serious mental illnesses are the most
important causes of suicidal thoughts or
actions.
• Watch for these changes and call your healthcare provider right
away if you notice:
• New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
• Pay particular attention to such changes when venlafaxine tablet
is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for
you
• other unusual changes in behavior or mood
Call your healthcare pro

Summary of Product characteristics

VENLAFAXINE - VENLAFAXINE TABLET
ALEMBIC PHARMACEUTICALS INC.
----------
VENLAFAXINE TABLETS, USP
RX ONLY
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
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 TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC
USE)
DESCRIPTION
Venlafaxine hydrochloride USP is a structurally novel antidepressant
for oral
administration. It is designated
(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]
cyclohexanol hydrochloride or
(±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl]
cyclohexanol hydrochloride and has the empirical formula of C
H
NO HCl. Its
molecular weight is 313.87.
The structural formula is shown below.
17
27
2
Venlafaxine hydrochloride USP is a white to off-white crystalline
solid with a solubility of
572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium
chloride). Its
octanol: water (0.2 M sodium chloride) partition coefficient is 0.43.
Com