VENLAFAXINE HYDROCHLORIDE- 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:

Mylan 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 four of the following eight 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 venlafa

Product summary:

Venlafaxine Tablets, USP are available containing venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine. The 25 mg tablets are yellow, round, scored tablets debossed with V above the score and 1 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4881-01 bottles of 100 tablets The 37.5 mg tablets are yellow, round, scored tablets debossed with V above the score and 2 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4882-01 bottles of 100 tablets The 50 mg tablets are yellow, round, scored tablets debossed with V above the score and 3 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4883-01 bottles of 100 tablets The 75 mg tablets are yellow, round, scored tablets debossed with M above the score and V4 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4884-01 bottles of 100 tablets The 100 mg tablets are yellow, round, scored tablets debossed with M above the score and V5 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4885-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Venlafaxine Tablets, USP
(ven'' la fax' een)
25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg
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 yo

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
MYLAN PHARMACEUTICALS INC.
----------
(EACH 25 MG, 37.5 MG, 50 MG, 75 MG AND 100 MG TABLET CONTAINS
VENLAFAXINE HYDROCHLORIDE, USP
EQUIVALENT TO 25 MG, 37.5 MG, 50 MG, 75 MG OR 100 MG VENLAFAXINE,
RESPECTIVELY)
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
US E.)
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-
[(Dimethylamino)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
Venlafaxine hydrochloride, USP is a white to off-white crystalline