VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessne

Product summary:

Venlafaxine hydrochloride extended-release capsules are available as follows: 37.5 mg - light-grey opaque cap/buff opaque body with “93” and “7384” on both body and cap. They are available in bottles of 30, 90 and 500. 75 mg - buff opaque cap/buff opaque body with “93” and “7385” on both body and cap. They are available in bottles of 30, 90 and 500. 150 mg - light-orange opaque cap/light-orange body with “93” and “7386” on both body and cap. They are available in bottles of 30, 90 and 500. Store at 20o to 25o C (68o   to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 9/2012

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Read the Medication Guide that comes with venlafaxine hydrochloride
extended-release capsules before
you start taking them 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 extended-release
capsules?
Venlafaxine hydrochloride extended-release capsules and other
antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Venlafaxine hydrochloride extended-release capsules 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 extended-
release capsules 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, rest

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
7384
7385
7386
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 EXTENDED-RELEASE CAPSULES 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
EXTENDED-RELEASE CAPSULES
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 extended-release capsules for oral
administration contain venlafaxine
hydrochloride, a structurally novel antidepressant. It is designated
(R/S)-1-[2-(dimethylamino)-1-(4-
methoxyphenyl)ethyl] cyclohexanol hydrochloride or
(±)-1-[α-[(dimethylamino)methyl]-_p_-
methoxybenzyl] cyclohexanol hydrochloride. The structural formula is
shown below.
C
H NO •HCl M.W. 313.87
Venlafaxine hydrochloride is a white to off-white crystalline solid
with a sol