VENLAFAXINE HYDROCHLORIDE capsule, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Sammensætning:

VENLAFAXINE 75 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 (seeClinical 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 worthlessness

Produkt oversigt:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Venlafaxine Hydrochloride Extended-release Capsules, 37.5 mg are white to off-white free flowing pellets filled in size ‘3’ hard gelatin capsules with grey colored cap printed with "ZA-35" in black ink & white body printed with "37.5 mg" in black ink and are supplied as follows: NDC 60429-121-30 in bottle of 30 capsules NDC 60429-121-90 in bottle of 90 capsules Venlafaxine Hydrochloride Extended-release Capsules, 75 mg are white to off-white free flowing pellets filled in size ‘1’ hard gelatin capsules with peach colored cap printed with "ZA-36" in black ink & white body printed with "75 mg" in black ink and are supplied as follows: NDC 60429-122-30 in bottle of 30 capsules NDC 60429-122-90 in bottle of 90 capsules Venlafaxine Hydrochloride Extended-release Capsules, 150 mg are white to off-white free flowing pellets filled in size ‘0’ hard gelatin capsules with dark orange colored cap printed with "ZA-37" in black ink & white body printed with "150 mg" in black ink and are supplied as follows: NDC 60429-123-30 in bottle of 30 capsules NDC 60429-123-90 in bottle of 90 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012 Rev.: 01/13 Revision Date: 19/01/2013

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Venlafaxine Hydrochloride Extended-release Capsules
Read the Medication Guide that comes with venlafaxine hydrochloride
extended-release capsules 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 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 o

Produktets egenskaber

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
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 capsule for oral
administration contains 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 and has the molecular
formula of C
H NO HCl. Its
molecular weight is 313.87. The structural formula is shown below.
Venlafaxine hydrochloride, USP is a white to off-white cryst