VENLAFAXINE HYDROCHLORIDE- venlafaxine tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Amneal Pharmaceuticals LLC

INN (Միջազգային անվանումը):

VENLAFAXINE HYDROCHLORIDE

Կազմը:

VENLAFAXINE 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

Venlafaxine Tablets USP, 25 mg are supplied as light orange, round deep convex tablets debossed “IP” bisect “301” on one side. It is available as follows: Bottles of 90:                                                  NDC 65162-300-09 Venlafaxine Tablets USP, 37.5 mg are supplied as light orange, round deep convex tablets debossed “IP” bisect “302” on one side. It is available as follows: Bottles of 90:                                                  NDC 65162-302-09 Venlafaxine Tablets USP, 50 mg are supplied as light orange, circular tablets debossed “IP” bisect “303” on one side. It is available as: Bottles of 90:                                                  NDC 65162-306-09 Venlafaxine Tablets USP, 75 mg are supplied as light orange, oval tablets debossed “IP” bisect “304” on one side. It is available as: Bottles of 90:                                                  NDC 65162-307-09 Venlafaxine Tablets USP, 100 mg are supplied as light orange, oval tablets debossed “IP” bisect “305” on one side. It is available as: Bottles of 90:                                                  NDC 65162-305-09 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature], in a dry place. Dispense in a well-closed container as defined in the USP. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 09-2023-08

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE TABLET
Amneal Pharmaceuticals LLC
----------
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 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 h

Ապրանքի հատկությունները

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE TABLET
AMNEAL PHARMACEUTICALS LLC
----------
VENLAFAXINE TABLETS, USP
(25 MG, 37.5 MG, 50 MG, 75 MG AND 100 MG)
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.
17
27
2
Venlafaxine HCl, 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:wate