DESVENLAFAXINE EXTENDED-RELEASE- desvenlafaxine tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW)

Dostupné s:

Macoven Pharmaceuticals

INN (Mezinárodní Name):

DESVENLAFAXINE

Složení:

DESVENLAFAXINE 50 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Desvenlafaxine Extended-Release Tablets are 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 Extended-Release Tablets 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 Extended-Release Tablets or within 7 days of stopping treatment with Desvenlafaxine Extended-Release Tablets is contraindicated because of an increased risk of serotonin syndrome. The use of Desvenlafaxine Extended-Release Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration  (2.8)   and  Warnings and Precautions  (5.2)]. -   Starting Desvenlafaxine Extended-Release Tablets in a patient who is being treated with MAOIs such as linezolid or intraveno

Přehled produktů:

Desvenlafaxine Extended-Release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 44183-880-31, bottle of 30 tablets in unit-of-use package NDC 44183-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 44183-890-31, bottle of 30 tablets in unit-of-use package NDC 44183-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Each 50 mg or 100 mg Desvenlafaxine Extended-Release Tablets contains 50 or 100 mg of desvenlafaxine, respectively.

Stav Autorizace:

New Drug Application Authorized Generic

Informace pro uživatele

Macoven Pharmaceuticals
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MEDICATION GUIDE
Desvenlafaxine
Extended-Release Tablets
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 are 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 talking (mania)
•
other unusual changes in behavior or mood
What is Desvenlafaxine Extended-Release Tablets?
•
Desvenlafaxine Extended-Release Tablets are a prescription medicine
used to treat adults with a certain type of
depression called major depressive disorder (MDD). Desvenlafaxine
Extended-Release Tablets belong to a class
of medicines known as serotonin and norepinephrine reuptake inhibitors

Charakteristika produktu

DESVENLAFAXINE EXTENDED-RELEASE- DESVENLAFAXINE TABLET, EXTENDED
RELEASE
MACOVEN PHARMACEUTICALS
----------
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 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
Dosage and Administration (2.5) 01/2019
Warnings and Precautions (5.2, 5.4, 5.5, 5.7) 01/2019
INDICATIONS AND USAGE
Desvenlafaxine Extended-Release Tablets are 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).
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 50
mg every other day (2.2).
Moderate to severe hepatic impairment: Maximum dose 100 mg per day
(2.3).
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 50 mg and 100 mg (3)
CONTRAINDICATIONS
Hypersensitivity to desvenlafaxine succinate, venlafaxine
hydrochloride or any excipients in the Desvenlafaxine
Extended-Release Tablets formulation (4).
_Serotonin syndrome and MAOIs_: Do not use MAOIs intended to treat
psychiatric disorder