EFFEXOR XR- venlafaxine hydrochloride capsule, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

PD-Rx Pharmaceuticals, Inc.

INN (Mezinárodní Name):

VENLAFAXINE HYDROCHLORIDE

Složení:

VENLAFAXINE 75 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Effexor XR (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. Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. Effexor XR 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. Effexor XR 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 with Effexor XR or within 7 days of discontinuing treatment with Effexor XR is contrai

Přehled produktů:

Effexor XR ® (venlafaxine hydrochloride) extended-release capsules are available as follows: 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. The appearance of these capsules is a trademark of Wyeth Pharmaceuticals.

Stav Autorizace:

New Drug Application

Informace pro uživatele

EFFEXOR XR- venlafaxine hydrochloride capsule, extended release
PD-Rx Pharmaceuticals, Inc.
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Medication Guide
EFFEXOR XR ® (e-fex-or)
(venlafaxine hydrochloride)
Extended-Release Capsules
Read the Medication Guide that comes with EFFEXOR 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 EFFEXOR XR?
EFFEXOR XR and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
EFFEXOR 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 EFFEXOR 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 behavior or mood
�

Charakteristika produktu

EFFEXOR XR- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EFFEXOR XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EFFEXOR XR.
EFFEXOR XR (VENLAFAXINE 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)
EFFEXOR XR IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS ( 8.4)
RECENT MAJOR CHANGES
Dosage and Administration, Discontinuing Effexor XR ( 2.8)
11/2021
Warnings and Precautions, Discontinuation Syndrome ( 5.7)
11/2021
Warnings and Precautions, Sexual Dysfunction ( 5.13)
9/2021
INDICATIONS AND USAGE
Effexor XR 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
INDICATION
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