VENLAFAXINE HYDROCHLORIDE capsule, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Preferred Pharmaceuticals Inc.

INN (שם בינלאומי):

VENLAFAXINE HYDROCHLORIDE

הרכב:

VENLAFAXINE 75 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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 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 psych

leaflet_short:

Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg are white to off-white free flowing pellets filled in Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with peach colored cap printed with "ZA-36" in black ink & white body printed with "75 mg" in black ink and are supplied as follows: NDC 68788-6424-2 in bottle of 20 capsules NDC 68788-6424-3 in bottle of 30 capsules NDC 68788-6424-6 in bottle of 60 capsules NDC 68788-6424-9 in bottle of 90 capsules NDC 68788-6424-1 in bottle of 100 capsules NDC 68788-6424-8 in bottle of 120 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
Preferred Pharmaceuticals Inc.
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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
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 dep

מאפייני מוצר

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PREFERRED 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._
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration, Discontinuing Venlafaxine Hydrochloride
Extended-
Release Capsules (2.8)
11/2021
Warnings and Precautions, Discontinuation Syndrome (5.7)
11/2021
Warnings and Precautions, Sexual Dysfunction (5.13)
09/2021
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin
and norepinephrine reuptake
inhibitor (SNRI) indicated for the treatment of: (1)
•
•
•
•
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
TARGET DOSE
MAXIMUM DOSE
MDD (2.1)
37.5 to75 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
•
•
•
•
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 CAPSULE 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 p