DESVENLAFAXINE tablet, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

A-S Medication Solutions

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 extended-release tablets [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 (2.7 ) and Warnings and Precautions ( 5.2 )] . - Starting desvenlafaxine extended-release tablets in a patient who is being treated with MAOIs such as

Produktu pārskats:

Product: 50090-4388 NDC: 50090-4388-0 30 TABLET, EXTENDED RELEASE in a BOTTLE

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

A-S Medication Solutions
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MEDICATION GUIDE
Desvenlafaxine (des ven” la fax’ een) 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 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 talking (mania)
•
other unusual changes in
behavior or mood
What are 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 norep

Produkta apraksts

DESVENLAFAXINE- DESVENLAFAXINE TABLET, EXTENDED RELEASE
A-S MEDICATION SOLUTIONS
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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
Dosage and Administration (2.5) 2/2018
Warnings and Precautions (5.2, 5.4, 5.5, 5.7) 2/2018
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).
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
succ