DESVENLAFAXINE tablet, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Golden State Medical Supply, Inc.

INN (Kansainvälinen yleisnimi):

DESVENLAFAXINE SUCCINATE

Koostumus:

DESVENLAFAXINE 25 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Desvenlafaxine extended-release tablets are available as follows: 50 mg, light pink, square, pyramid tablets imprinted with “WPI” and “3659” in black ink on one side NDC 51407-022-90, bottle of 90 tablets in unit-of-use package 100 mg, reddish-orange, square, pyramid tablets imprinted with “WPI” and “3660” in black ink on one side NDC 51407-023-90, 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 tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Golden State Medical Supply, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Desvenlafaxine (desʺ-ven-la-faxʹ-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 extend

Valmisteyhteenveto

DESVENLAFAXINE- DESVENLAFAXINE TABLET, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DESVENLAFAXINE
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, Discontinuing Desvenlafaxine
Extended-Release Tablets ( 2.5)
11/2021
Warnings and Precautions, Discontinuation Syndrome ( 5.7)
11/2021
Warnings and Precautions, Sexual Dysfunction ( 5.11)
9/2021
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