VENLAFAXINE HYDROCHLORIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 venlafaxine h

leaflet_short:

Venlafaxine Tablets, USP are available as follows: 25 mg - mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “1” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9147-01). 37.5 mg - mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “2” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9148-01). 50 mg - mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “3” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9149-01). 75 mg - mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablets has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “4” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9157-01). 100 mg - mottled peach, round, flat beveled tablet, scored on both sides. One side of the tablet has embossing “T” on one side of the score and “V” on the other side of the score. The opposite side of the tablet has embossing “5” on one side of the score and “K” on the other side of the score. It is available in bottles of 100 (NDC 0093-9163-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. W 8/2023

מצב אישור:

Abbreviated New Drug Application

עלון מידע

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
Teva Pharmaceuticals USA, Inc.
----------
Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Venlafaxine (ven'' la fax' een) Tablets
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 m

מאפייני מוצר

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
TEVA PHARMACEUTICALS USA, INC.
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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
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
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. The structural formula is shown below.
C
H
NO •HCl M.W. 313.87
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) partition coefficient is 0.43.
Compressed tablets contain venla