VENLAFAXINE - venlafaxine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 50 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 hydrochloride 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 venla

Product summary:

Venlafaxine Tablets are available as follows: 25 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “246” on the other side. Available in bottles of 20 (NDC 23155-246-07), 90 (NDC 23155-246-09),100  (NDC 23155-246-01) and 500 (NDC 23155-246-05). 37.5 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “247” on the other side Available in bottles of 20 (NDC 23155-247-07),  90 (NDC 23155-247-09),100  (NDC 23155-247-01) and 500 (NDC 23155-247-05). 50 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “248” on the other side. Available in bottles of 20 (NDC 23155-248-07), 90 (NDC 23155-248-09), 100  (NDC 23155-248-01) and 500 (NDC 23155-248-05). 75 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “249” on the other side. Available in bottles of 20 (NDC 23155-249-07), 90 (NDC 23155-249-09),100  (NDC 23155-249-01) and 500 (NDC 23155-249-05). 100 mg – Orange colored, oval, biconvex, film-coated tablets with side wall scored; debossed with “H” and “P” separated by score line on one side and “250” on the other side. Available in bottles of 20 (NDC 23155-250-07), 90 (NDC 23155-250-09), 100  (NDC 23155-250-01) and 500 (NDC 23155-250-05). Store at 20°-25°C (68°-77°F) in a dry place [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. The unit of use package is intended to be dispensed as a unit. Manufactured by: Emcure Pharmaceuticals Ltd., India. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Rev. 09/13

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE - VENLAFAXINE TABLET
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Read the Medication Guide that comes with venlafaxine tablets, USP
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, USP?
Venlafaxine tablets, USP and 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
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, USP
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 provider right away if you

Summary of Product characteristics

VENLAFAXINE - VENLAFAXINE TABLET
BRYANT RANCH PREPACK
----------
VENLAFAXINE TABLETS, USP
BOXED 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 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 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.
VENLAFAXINE HYDROCHLORIDE
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) parti