VENLAFAXINE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Contract Pharmacy Services-PA

INN (Международно Name):

VENLAFAXINE HYDROCHLORIDE

Композиция:

VENLAFAXINE 75 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Venlafaxine tablets, USP is 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 ide

Каталог на резюме:

Venlafaxine Tablets, USP are available as follows: 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 the following: NDC 67046-852-07 blisterpacks of 7 NDC 67046-852-14 blisterpacks of 14 NDC 67046-852-15 blisterpacks of 15 NDC 67046-852-20 blisterpacks of 20 NDC 67046-852-21 blisterpacks of 21 NDC 67046-852-28 blisterpacks of 28 NDC 67046-852-30 blisterpacks of 30 NDC 67046-852-60 blisterpacks of 60 Store at 20°-25°C (68°-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). The unit of use package is intended to be dispensed as a unit. Manufactured by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Rev. 10/16 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Rev: Original—2017.09.21—NJW

Статус Оторизация:

Abbreviated New Drug Application

Листовка

VENLAFAXINE- VENLAFAXINE TABLET
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
Venlafaxine Tablets, USP
(ven la fax een)
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, USP 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 behavior or mood
Call your healt

Данни за продукта

VENLAFAXINE- VENLAFAXINE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
852 VENLAFAXINE TABLETS, USP RX ONLY
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 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 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 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) p