VENLAFAXINE HYDROCHLORIDE capsule, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Proficient Rx LP

DCI (Denominação Comum Internacional):

VENLAFAXINE HYDROCHLORIDE

Composição:

VENLAFAXINE 37.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Proficient Rx LP
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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 anxiety or panic a

Características técnicas

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PROFICIENT RX LP
----------
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._
•
•
•
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release is a serotonin and
norepinephrine reuptake inhibitor (SNRI) indicated for the
treatment of: (1)
•
•
•
•
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
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)
Major Depressive Disorder (MDD)
Generalized Anxiety Disorder (GAD)
Social Anxiety Disorder (SAD)
Panic Disorder (PD)
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 cirrh