DESVENLAFAXINE SUCCINATE tablet, film coated, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DESVENLAFAXINE SUCCINATE (UNII: ZB22ENF0XR) (DESVENLAFAXINE - UNII:NG99554ANW)

Beszerezhető a:

Lupin Pharmaceuticals, Inc.

INN (nemzetközi neve):

DESVENLAFAXINE SUCCINATE

Összetétel:

DESVENLAFAXINE 50 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)]. - Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation. Angioedema has been reported in patients treated with desvenlafaxine [see ADVERSE REACTIONS (6.1)]. - The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. The use of desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see DOSAGE AND ADMINISTRATION (2.7) and WARNINGS AND PRECAUTIONS (5.2)]. - Starting desvenlafaxine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin

Termék összefoglaló:

Desvenlafaxine extended-release tablets are available as follows: 25 mg, tan, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S67" on the other side. NDC 68180-604-06, bottle of 30 tablets in unit-of-use package 50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side. NDC 68180-592-06, bottle of 30 tablets in unit-of-use package 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side. NDC 68180-593-06, bottle of 30 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

DESVENLAFAXINE SUCCINATE- DESVENLAFAXINE SUCCINATE TABLET, FILM
COATED, EXTENDED RELEASE
Lupin Pharmaceuticals, Inc.
----------
SPL MEDGUIDE
MEDICATION GUIDE
Desvenlafaxine (des-VEN-la-FAX-een)
Extended-Release Tablets
Read this Medication Guide before you start taking Desvenlafaxine
Extended-Release Tablets and each
time you get a refill. There may be new information. This information
does not take the place of talking to
your healthcare provider about your medical condition or treatment.
What is the most important information I should know about
desvenlafaxine
extended-release tablets?
Desvenlafaxine extended-release tablets can cause serious side
effects, including:
•
Increased risk of suicidal thoughts or actions in some children and
young adults within the first
few months of treatment. Desvenlafaxine extended-release tablets is
not for use in children.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
How can I watch for and try to prevent suicidal thoughts and actions?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, especially if they
are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling very agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and tal

Termékjellemzők

DESVENLAFAXINE SUCCINATE- DESVENLAFAXINE SUCCINATE TABLET, FILM
COATED,
EXTENDED RELEASE
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESVENLAFAXINE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DESVENLAFAXINE EXTENDED-RELEASE TABLETS.
DESVENLAFAXINE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN CHILDREN,
ADOLESCENTS AND
YOUNG ADULTS TAKING ANTIDEPRESSANTS (5.1).
CLOSELY MONITOR FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND
BEHAVIORS (5.1).
DESVENLAFAXINE EXTENDED-RELEASE TABLETS ARE NOT APPROVED FOR USE IN
PEDIATRIC
PATIENTS (8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.4)
08/2023
INDICATIONS AND USAGE
Desvenlafaxine extended-release tablet, is a serotonin and
norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of adults with major depressive disorder
(MDD) (1).
DOSAGE AND ADMINISTRATION
Recommended dose: 50 mg once daily with or without food (2.1).
There was no evidence that doses greater than 50 mg per day confer any
additional benefit (2.1).
The 25 mg per day dose is intended for a gradual reduction in dose
when discontinuing treatment or
dosing in severe renal and end-stage renal disease patients (2.1).
Discontinuation: Reduce dose gradually whenever possible (2.1).
Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
Moderate renal impairment: Maximum dose 50 mg per day (2.2).
Severe renal impairment and end-stage renal disease: Maximum dose 25
mg per day or 50 mg every
other day (2.2).
Moderate to severe hepatic impairment: Maximum dose 100 mg per day
(2.3).
DOSAGE FORMS AND STRENGTHS
Desvenlafaxine extended-release tablets: 25 mg, 50 mg and 100 mg (3).
Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine
succinate monohyd