VENLAFAXINE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Zydus Pharmaceuticals USA Inc.

INN (nemzetközi neve):

VENLAFAXINE HYDROCHLORIDE

Összetétel:

VENLAFAXINE 25 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Venlafaxine tablets, USP are 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 ven

Termék összefoglaló:

Venlafaxine Tablets, USP equivalent to 25 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of  "ZC" and other side is debossed with "64" and other side is plain and are supplied as follows: NDC 68382-018-06 in bottles of 30 tablets with child-resistant closure NDC 68382-018-14 in bottles of 60 tablets with child-resistant closure NDC 68382-018-16 in bottles of 90 tablets with child-resistant closure NDC 68382-018-01 in bottles of 100 tablets NDC 68382-018-05 in bottles of 500 tablets NDC 68382-018-10 in bottles of 1000 tablets Venlafaxine Tablets, USP equivalent to 37.5 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of "ZC" and other side is debossed with "65" and other side is plain and are supplied as follows: NDC 68382-019-06 in bottles of 30 tablets with child-resistant closure NDC 68382-019-14 in bottles of 60 tablets with child-resistant closure NDC 68382-019-16 in bottles of 90 tablets with child-resistant closure NDC 68382-019-01 in bottles of 100 tablets NDC 68382-019-05 in bottles of 500 tablets NDC 68382-019-10 in bottles of 1000 tablets Venlafaxine Tablets, USP equivalent to 50 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 "66"  and other side is plain and are supplied as follows: NDC 68382-020-06 in bottles of 30 tablets with child-resistant closure NDC 68382-020-14 in bottles of 60 tablets with child-resistant closure NDC 68382-020-16 in bottles of 90 tablets with child-resistant closure NDC 68382-020-01 in bottles of 100 tablets NDC 68382-020-05 in bottles of 500 tablets NDC 68382-020-10 in bottles of 1000 tablets Venlafaxine Tablets, USP 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 68382-021-06 in bottles of 30 tablets with child-resistant closure NDC 68382-021-14 in bottles of 60 tablets with child-resistant closure NDC 68382-021-16 in bottles of 90 tablets with child-resistant closure NDC 68382-021-01 in bottles of 100 tablets NDC 68382-021-05 in bottles of 500 tablets NDC 68382-021-10 in bottles of 1000 tablets Venlafaxine Tablets, USP equivalent to 100 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 "68" and other side is plain and are supplied as follows: NDC 68382-101-06 in bottles of 30 tablets with child-resistant closure NDC 68382-101-14 in bottles of 60 tablets with child-resistant closure NDC 68382-101-16 in bottles of 90 tablets with child-resistant closure NDC 68382-101-01 in bottles of 100 tablets NDC 68382-101-05 in bottles of 500 tablets NDC 68382-101-10 in bottles of 1000 tablets Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP. KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

VENLAFAXINE- VENLAFAXINE TABLET
Zydus Pharmaceuticals USA Inc.
----------
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 healt

Termékjellemzők

VENLAFAXINE- VENLAFAXINE TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
VENLAFAXINE TABLETS, USP
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
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 C
H
NO HCl. Its molecular weight is
313.87. The structural formula is shown below.
VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochloride, USP is a white to off-white crystalline
powder. It is soluble in
methanol and in water. Its octanol:water (0.2 M sodium chloride)
partition coefficient is
0.43.
Each venlafaxine tablet, USP intended for oral adminis