VENLAFAXINE- venlafaxine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine tablets, USP are 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 ef

Product summary:

Venlafaxine Tablets USP, 25 mg are peach colored, circular, biconvex, uncoated tablets debossed with 'I' and breakline on one side and '17' on the other side. Venlafaxine Tablets USP, 37.5 mg are peach colored, circular, biconvex, uncoated tablets debossed with 'I' and breakline on one side and '19' on the other side. Venlafaxine Tablets USP, 50 mg are peach colored, circular, biconvex, uncoated tablets debossed with 'I' and breakline on one side and '20' on the other side. Venlafaxine Tablets USP, 75 mg are peach colored, circular, biconvex, uncoated tablets debossed with 'I' and breakline on one side and '21' on the other side. 55700-816-90 Venlafaxine Tablets USP, 100 mg are peach colored, circular, biconvex, uncoated tablets debossed with 'I' and breakline on one side and '22' on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP. Dispense with medication guide available at: http://www.risingpharma.com/med-guides.html. Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/19/1993 Revised: 03/2019

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE- VENLAFAXINE HYDROCHLORIDE TABLET
Quality Care Products, LLC
----------
MEDICATION GUIDE
Venlafaxine Tablets, USP
(ven'' la fax' een hye'' droe klor' ide)
Read the Medication Guide that comes with venlafaxine tablets before
you start taking them 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 tablets are
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 be

Summary of Product characteristics

VENLAFAXINE- VENLAFAXINE HYDROCHLORIDE TABLET
QUALITY CARE PRODUCTS, LLC
----------
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 HYDROCHLORIDE 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 HYDROCHLORIDE 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 hydrochloride 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 molecular formula
of C
H NO HCl. Its molecular weight is 313.87. The structural formula is
shown below.
Venlafaxine hydrochloride USP is a white or almost white crystalline
powder 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