VENLAFAXINE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Proficient Rx LP

INN (Nama Internasional):

VENLAFAXINE HYDROCHLORIDE

Komposisi:

VENLAFAXINE 100 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Venlafaxine Tablets, USP are available containing 100 mg of venlafaxine. 100 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with ‘L179’ on one side and breakline on other side. NDC 63187-752-30 bottle of 30 tablets. NDC 63187-752-60 bottle of 60 tablets. NDC 63187-752-90 bottle of 90 tablets. 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. * Different strengths of the drug product mentioned in the package insert are based on Venlafaxine base. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320 USA Revised: 10/2016

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

VENLAFAXINE- VENLAFAXINE TABLET
Proficient Rx LP
----------
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
is 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

Karakteristik produk

VENLAFAXINE- VENLAFAXINE TABLET
PROFICIENT RX LP
----------
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
US E)
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) partition coefficient is 0.43.
17
27
2
chloride) parti