VENLAFAXINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St. Marys Medical Park Pharmacy

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride 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

Product summary:

HOW SUPPLIED Venlafaxine Hydrochloride Tablets equivalent to 75 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "67" and other side is plain and are supplied as follows: NDC 60760-121-30 BOTTLES OF 30

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

St. Marys Medical Park Pharmacy
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VENLAFAXINE- venlafaxine tablet
Zydus Pharmaceuticals (USA) Inc.
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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:
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 healthcare provider right away

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
ST. MARYS MEDICAL PARK PHARMACY
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VENLAFAXINE HYDROCHLORIDE
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 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 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 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 molecular formula of C17H27NO2 HCl. Its
molecular weight is
313.87. The structural formula is shown below.
Venlafaxine hydrochloride is a white crystalline powder. It is freely
soluble in water and
dilute hydrochloric acid, soluble in ethanol and chloroform and
insoluble in ether.
Each venlafaxine hydrochloride t