VENLAFAXINE HYDROCHLORIDE 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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 75 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 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

Product summary:

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.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
VENLAFAXINE XR
(venlafaxine hydrochloride)
(Extended-Release Capsules)
Read the Medication Guide that comes with venlafaxine hydrochloride
extended-release 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?
Venlafaxine hydrochloride extended-release and other antidepressant
medicines may cause serious side
effects, including:
1.
Suicidal thoughts or actions:
•
Venlafaxine hydrochloride extended-release 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
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

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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
Venlafaxin