VENLAFAXINE HYDROCHLORIDE capsule, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Proficient Rx LP

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 guilt or wor

Resumen del producto:

Venlafaxine Hydrochloride Extended-Release Capsules USP are available as follows: 75 mg - buff opaque cap/buff opaque body with “93” and “7385” on both body and cap. They are available in bottles of 30, 60, and 90. 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. H 7/2014 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Proficient Rx LP
----------
MEDICATION GUIDE
Venlafaxine (ven la fax een) Hydrochloride Extended-Release Capsules
USP
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:
o
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
o
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 pan

Fitxa tècnica

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PROFICIENT RX LP
----------
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 USE).
DESCRIPTION
Venlafaxine Hydrochloride Extended-Release Capsules USP for oral
administration
contain 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. The structural formula is shown below.
C
H
NO •HCl M.W. 313.87
Venlafaxine hydrochloride, USP is a white to off-white crystalline
solid with a solubility of
572 mg/mL in water (