VENLAFAXINE HYDROCHLORIDE- venlafaxine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

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 efficacy of venlafaxin

Product summary:

Venlafaxine Tablets USP, 25 mg, are supplied as light orange, round deep convex tablets debossed “IP” bisect “301” on one side. They are supplied as follows: NDC 50268-798-15 (10 tablets per card, 5 cards per carton). Venlafaxine Tablets USP, 37.5 mg, are supplied as light orange, round deep convex tablets debossed “IP” bisect “302” on one side. They are supplied as follows: NDC 50268-799-15 (5 tablets per card, 10 cards per carton). Venlafaxine Tablets USP, 50 mg, are supplied as light orange, circular tablets debossed “IP” bisect “303” on one side. They are supplied as follows: NDC 50268-800-15 (10 tablets per card, 5 cards per carton). Venlafaxine Tablets USP, 75 mg, are supplied as light orange, oval tablets debossed “IP” bisect “304” on one side. They are supplied as follows: NDC 50268-801-13 (5 tablets per card, 6 cards per carton). Venlafaxine Tablets USP, 100 mg, are supplied as light orange, oval tablets debossed “IP” bisect “305” on one side. Dispensed in Unit Dose package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature], in a dry place. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 01-2019-04 Av Rev. 04/19 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- venlafaxine tablet
AvPAK
----------
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 HCl 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 behavior or mood
Call your healthcare provider right

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE TABLET
AVPAK
----------
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 (HCl), 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 HCl, USP is a white to off-white crystalline solid with a
solubility of 572
17
27
2
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.
Compr