VENLAFAXINE HYDROCHLORIDE capsule, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

DIRECT RX

INN (Tarptautinis Pavadinimas):

VENLAFAXINE HYDROCHLORIDE

Sudėtis:

VENLAFAXINE 150 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Major Depressive Disorder 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 fa

Produkto santrauka:

Venlafaxine hydrochloride extended-release capsules are available as follows: 37.5 mg, grey cap/peach body with W and “Effexor XR” on the cap and “37.5” on the body. NDC 60505-3778-3, bottle of 30 capsules in unit of use package. NDC 60505-3778-9, bottle of 90 capsules in unit of use package. 75 mg, peach cap and body with W and “Effexor XR” on the cap and “75” on the body. NDC 60505-3779-3, bottle of 30 capsules in unit of use package. NDC 60505-3779-9, bottle of 90 capsules in unit of use package. 150 mg, dark orange cap and body with W and “Effexor XR” on the cap and “150” on the body. NDC 60505-3780-3, bottle of 30 capsules in unit of use package. NDC 60505-3780-9, bottle of 90 capsules in unit of use package. Store at controlled room temperature, 20° to 25°C (68° to 77°F). The unit of use package is intended to be dispensed as a unit. Distributed by: Apotex Corp. Weston, Florida 33326 LAB-0501-14.0

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
DIRECT RX
----------
SPL MEDGUIDE SECTION
VENLAFAXINE XR
(venlafaxine hydrochloride)
(Extended-Release Capsules)
Read the Medication Guide that comes with VENLAFAXINE XR 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
XR?
VENLAFAXINE XR and other antidepressant medicines may cause serious
side effects, including:
1.Suicidal thoughts or actions:
•
VENLAFAXINE XR 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 XR is
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 talking more than what is normal for you
•
other unusual changes in behavi

Prekės savybės

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
DIRECT RX
----------
VENLAFAXINE HYDROCHLORIDE
BOXED WARNING SECTION
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 SECTION
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 and has the empirical
formula of C17H27NO2 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 solubilit