VENLAFAXINE HYDROCHLORIDE capsule, extended release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Medsource Pharmaceuticals

INN (Jina la Kimataifa):

VENLAFAXINE HYDROCHLORIDE

Tungo:

VENLAFAXINE 37.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. Venlafaxine hydrochloride extended-release is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. Venlafaxine hydrochloride extended-release is indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials. Venlafaxine hydrochloride extended-release is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation The use of MAOIs (intended to treat psychiatric disorders) concomitantly wit

Bidhaa muhtasari:

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.

Idhini hali ya:

New Drug Application Authorized Generic

Taarifa za kipeperushi

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Medsource Pharmaceuticals
----------
MEDICATION GUIDE
VENLAFAXINE XR
(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:
•
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 capsulesis 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 anxie

Tabia za bidhaa

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MEDSOURCE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE HYDROCHLORIDE
EXTENDED-RELEASE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE.
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
INITIAL U.S. APPROVAL: 1997
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS ( 5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
( 5.1)
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE IS NOT APPROVED FOR USE IN
PEDIATRIC PATIENTS ( 8.4)
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release is a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for the
treatment of: (1)
Major Depressive Disorder (MDD)
Generalized Anxiety Disorder (GAD)
Social Anxiety Disorder (SAD)
Panic Disorder (PD)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD ( 2.1)
37.5 –75 mg/day
75 mg/day
225 mg/day
GAD ( 2.2)
37.5 –75 mg/day
75 mg/day
225 mg/day
SAD ( 2.3)
75 mg/day
75 mg/day
75 mg/day
PD ( 2.4)
37.5 mg/day
75 mg/day
225 mg/day
Take once daily with food ( 2). Capsules should be taken whole; do not
divide, crush, chew, or dissolve ( 2).
When discontinuing treatment, reduce the dose gradually ( 2.8, 5.7).
Renal impairment: reduce the total daily dose by 25% to 50% in
patients with renal impairment. Reduce the total daily
dose by 50% or more in patients undergoing dialysis or with severe
renal impairment ( 2.6).
Hepatic impairment: reduce the daily dose by 50% in patients with mild
to moderate hepatic impairment. In patients
with severe hepatic impairment or hepatic cirrhosis, it may be
necessary to reduce the dose by more than 50% ( 2.6).
DOSAGE FORMS AND STRENGTHS
Venlafaxine h