VENLAFAXINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northstar Rx LLC

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP 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 efficacy of

Product summary:

Venlafaxine Tablets, USP 25 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘392’ on one side and scored on the other side are available as follows: Bottles of 100 NDC 16714-655-01 Venlafaxine Tablets, USP 37.5 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘393’ on one side and scored on the other side are available as follows: Bottles of 100 NDC 16714-656-01 Venlafaxine Tablets, USP 50 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘394’ on one side and scored on the other side are available as follows: Bottles of 100 NDC 16714-657-01 Venlafaxine Tablets, USP 75 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘395’ on one side and scored on the other side are available as follows: Bottles of 100 NDC 16714-658-01 Venlafaxine Tablets, USP 100 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘396’ on one side and scored on the other side are available as follows: Bottles of 100 NDC 16714-659-01 Store at 20° to 25°C (68° to 77°F) excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Medication Guide available at www.northstarrxllc.com/products or call 1-800-206-7821 Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvári Kabay János u. 29. Hungary Revised: 08/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE- VENLAFAXINE TABLET
Northstar Rx LLC
----------
Venlafaxine (ven-la-fax-een) Tablets, USP
Read the Medication Guide that comes with venlafaxine tablets,
USPbefore 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, USP?
Venlafaxine tablets, USPand other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Venlafaxine tablets, USP and other antidepressant medicines may
increase suicidal thoughts or
actionsin 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 tablets,
USPis 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 provider right a

Summary of Product characteristics

VENLAFAXINE- VENLAFAXINE TABLET
NORTHSTAR RX LLC
----------
VENLAFAXINE TABLETS, USP
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, USP 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, USP IS NOT APPROVED FOR USE IN
PEDIATRIC
PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC
USE).
DESCRIPTION
Venlafaxine tablets, 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-[(dimethylamino)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 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.
Compressed tablets contain