VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride e-r capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules 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 to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicat

Product summary:

150 mg - light-orange opaque cap/light-orange opaque body with 93 and 7386 on both body and cap. They are available in bottles of 90 (NDC 68071-1673-9) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE E-R CAPSULE,
EXTENDED RELEASE
NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Venlafaxine (VEN la fax een) Hydrochloride Extended-Release Capsules
USP
Read the Medication Guide that comes with venlafaxine hydrochloride
extended-release capsules before
you start taking them 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:
2.
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.
3.
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
4.
Watch for these changes and call your healthcare provider right away
if you notice:
5.
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
6.
Pay particular attention to such changes when venlafaxine
hydrochloride extended-release
capsules are 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

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE E-R CAPSULE,
EXTENDED RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
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 )
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome ( 5.2) 1/2017
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin
and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of: (1)
Major Depressive Disorder (MDD)
Panic Disorder (PD)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD ( 2.1)
37.5 to 75 mg/day
75 mg/day
225 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 hydrochloride ext