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:

Wockhardt USA LLC.

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Sammensætning:

VENLAFAXINE 37.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Venlafaxine hydrochloride extended-release capsules, USP 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 capsules, USP are 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 capsules, USP are 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 capsules, USP are 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

Produkt oversigt:

Venlafaxine hydrochloride extended-release capsules, USP are available as follows: ●   37.5 mg, grey opaque cap and cream opaque body imprinted with      "W" on cap in red color.      716 NDC 64679-716-01, bottle of 30 capsules NDC 64679-716-04, bottle of 90 capsules NDC 64679-716-05, bottle of 500 capsules NDC 64679-716-02, bottle of 1000 capsules NDC 64679-716-03, Unit dose blister pack of 2 x 8 capsules ●   75 mg, cream opaque cap and cream opaque body imprinted with      "W" on cap in red color.      717 NDC 64679-717-01, bottle of 30 capsules NDC 64679-717-04, bottle of 90 capsules NDC 64679-717-05, bottle of 500 capsules NDC 64679-717-02, bottle of 1000 capsules NDC 64679-717-03, Unit dose blister pack of 2 x 8 capsules ●   150 mg, light brown opaque cap and light brown opaque body imprinted with      "W" on cap in white color.      718 NDC 64679-718-01, bottle of 30 capsules NDC 64679-718-04, bottle of 90 capsules NDC 64679-718-05, bottle of 500 capsules NDC 64679-718-02, bottle of 1000 capsules NDC 64679-718-03 Unit dose blister pack of 2 x 8 capsules Store at 20°-25°C (68°-77°F), [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Wockhardt USA LLC.
----------
MEDICATION GUIDE
Venlafaxine Hydrochloride (VEN-la-FAX-een HYE-droe-KLOR-ide)
Extended-Release Capsules, USP
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
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 o

Produktets egenskaber

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
WOCKHARDT USA LLC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
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 CAPSULES ARE NOT APPROVED
FOR USE IN PEDIATRIC PATIENTS (
8 .4 )
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules, USP are 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 to 75 mg/day
75 mg/day
225 mg/day
GAD (2.2)
37.5 to 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