VENLAFAXINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Sammensetning:

VENLAFAXINE 37.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Venlafaxine Hydrochloride Tablets are available as follows: 25 mg – peach, round, flat-faced, beveled edge, scored tablets, debossed "6147" on one side and debossed "V" on the reverse side, are supplied as follows: 37.5 mg – peach, round, flat-faced, beveled edge, scored tablets, debossed "6148" on one side and debossed "V" on the reverse side, are supplied as follows: 50 mg – peach, round, flat-faced, beveled edge, scored tablets, debossed "6149" on one side and debossed "V" on the reverse side, are supplied as follows: 75 mg – peach, round, flat-faced, beveled edge, scored tablets, debossed "6150" on one side and debossed "V" on the reverse side, are supplied as follows: 100 mg – peach, round, flat-faced, beveled edge, scored tablets, debossed "6151" on one side and debossed "V" on the reverse side, are supplied as follows: 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. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182538 R12/12-R5 A SUPPLY OF MEDICATION GUIDES AS PRINTED AT THE END OF THIS INSERT IS AVAILABLE, FREE OF CHARGE, BY CALLING [phone].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
VENLAFAXINE HYDROCHLORIDE TABLETS
Rx only
Read the Medication Guide that comes with venlafaxine hydrochloride
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
hydrochloride tablets?
Venlafaxine hydrochloride tablets and other antidepressant medicines
may cause serious side effects,
including:
1. Suicidal thoughts or actions:
•
Venlafaxine hydrochloride 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
hydrochloride 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

Preparatomtale

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
VENLAFAXINE HYDROCHLORIDE TABLETS
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 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 empirical formula
of C
H NO HCl. Its molecular weight is 313.87. The structural formula is
shown below.
Venlafaxine hydrochloride is a white to off-white crystalline solid
with a solubility of 572 mg/mL in
17
27
2
water (adjusted to ionic strength of 0.2 M with sodium chloride). Its
octa