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:

KAISER FOUNDATION HOSPITALS

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine hydrochloride extended-release capsules USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride extended-release capsules USP 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 g

Product summary:

Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘3’) of opaque grey color cap and opaque peach color body imprinted with “E” on cap and “73” on the body with edible black ink.                            Bottles of 100                                        NDC 0179-0161-01 Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘1’) of opaque peach color cap and opaque peach color body imprinted with “E” on cap and “74” on the body with edible black ink.                            Bottles of 100                                        NDC 0179-0162-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India Revised: 07/2014 Repackaged by: KAISER FOUNDATION HOSPITALS Livermore, CA 94551

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
KAISER FOUNDATION HOSPITALS
----------
MEDICATION GUIDE
Venlafaxine Hydrochloride Extended-Release Capsules USP
(ven'' la fax' een hye'' droe klor' ide)
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 dep

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
KAISER FOUNDATION HOSPITALS
----------
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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 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 USP are for oral
administration that contains
venlafaxine hydrochloride USP, 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
and has the molecular formula
of C
H
NO
•HCl. Its molecular weight is 313.87. The structural formula is
shown below.
17
27
2
Venlafaxine hydrochloride USP is