VENLAFAXINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Golden State Medical Supply, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS ). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation. The use of MAOIs intended to treat psychiatric disorders with Venlafaxine tablets, USP or within 7 days of stopping treatment with venlafaxine tablets, USP is contraindicated because of an increased risk of serotonin syndrome. The use of Venlafaxine tablets, USP within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see  WARNINGS and DOSAGE AND ADMINISTRATION ). Starting venlafaxine tablets, USP in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see  WARNINGS and DOSAGE AND ADMINISTRATION ). Venlafaxine tablets, USP is not a controlled substance. In vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (PCP), or N-methyl-D-aspartic acid (NMDA) receptors. Venlafaxine was not found to have any significant CNS stimulant activity in rodents. In primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. Discontinuation effects have been reported in patients receiving venlafaxine (see DOSAGE AND ADMINISTRATION ). While venlafaxine tablets, USP has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine tablets, USP (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).  

Produkt oppsummering:

Venlafaxine Tablets, USP 25 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘392’ on one side and scored on the other side are available as follows: Bottles of 90 NDC 51407-453-90 Venlafaxine Tablets, USP 37.5 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘393’ on one side and scored on the other side are available as follows: Bottles of 90 NDC 51407-454-90 Venlafaxine Tablets, USP 50 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘394’ on one side and scored on the other side are available as follows: Bottles of 90 NDC 51407-455-90 Venlafaxine Tablets, USP 75 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘395’ on one side and scored on the other side are available as follows: Bottles of 90 NDC 51407-456-90 Venlafaxine Tablets, USP 100 mg are peach colored, shield-shaped, uncoated, flat-faced beveled edge, tablets debossed with ‘396’ on one side and scored on the other side are available as follows: Bottles of 90 NDC 51407-457-90 Store at 20° to 25°C (68° to 77°F) excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvári Kabay János u. 29. Hungary Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised: 08/2023 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

VENLAFAXINE- VENLAFAXINE TABLET
Golden State Medical Supply, Inc.
----------
Medication Guide
Venlafaxine (ven-la-fax-een) Tablets, USP
Read the Medication Guide that comes with venlafaxine tablets,
USPbefore 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, USP?
Venlafaxine tablets, USPand other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
• Venlafaxine tablets, USP and other antidepressant medicines may
increase suicidal thoughts or actionsin
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, USPis 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 provid

Preparatomtale

VENLAFAXINE- VENLAFAXINE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
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, USP 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, USP 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 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 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 hydrochloride 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.
C