VENLAFAXINE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Nama Antarabangsa):

VENLAFAXINE HYDROCHLORIDE

Komposisi:

VENLAFAXINE 50 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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 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. 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 0615-7557-39 in blistercards of 30 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 0615-6567-39 in blistercards of 30 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 0615-7558-39 in blistercards of 30 tablets Storage     Store at 20º to 25ºC (68º to 77ºF) {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. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534    Rev.:02/13 Revision Date: 06/02/2013                                 

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

VENLAFAXINE- VENLAFAXINE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 is a structurally novel antidepressant for
oral administration. It is designated
(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexenol
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 int