DESVENLAFAXINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

DESVENLAFAXINE

Composition:

DESVENLAFAXINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desvenlafaxine 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 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 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 syndrome [see Dosage and Administration (2.8) and

Product summary:

Desvenlafaxine extended-release tablets are available as follows: 50 mg, light pink colored, diamond shaped, biconvex tablets, debossed with ‘L189’ on one side and plain on other side . NDC 63304-191-30, bottle of 30 tablets NDC 63304-191-90, bottle of 90 tablets 100 mg, dark brown to red colored, diamond shaped, biconvex tablets, debossed with ‘L190’ on one side and plain on other side. NDC 63304-192-30, bottle of 30 tablets NDC 63304-192-90, bottle of 90 tablets 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 extended-release tablet contains 50 or 100 mg of desvenlafaxine, USP respectively.

Authorization status:

New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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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?
Desvenlafaxine can cause serious side effects, including:
o Increased risk of suicidal thoughts or actions in some children,
adolescents and young adults.
Desvenlafaxine and other antidepressant medicines may increase
suicidal thoughts and actions in some
people 24 years of age and younger, especially within the first few
months of treatment or when the dose
is changed. Desvenlafaxine is not for use in children.
• Depression or other serious mental illnesses are the most
important causes of suicidal thoughts or
actions. Some people may have a higher risk of having suicidal
thoughts or actions. These include people
who have (or have a family history of) depression, bipolar illness
(also called manic-depressive illness) or
have a history of suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions?
o Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings, or if you develop suicidal thought or actions. This is very
important when an antidepressant
medicine is started or when the dose is changed.
o Call your healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or feelings.
o Keep all follow-up visits with your healthcare provider as
scheduled. Call your healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call your healthcare provider or get emergency help right away if you
or a family member have any of
the following symptoms, especially if they are new, worse, or worry
you:
o thoughts about suicide or dying o trouble sleeping (insomnia)
o attempts to commit suicide o new or worse irritability
o new or worse depression o acting aggressive, being angry, or violent
o new or worse anxiety o acting on dangerous impulses
o feeling very agitated or restles

Summary of Product characteristics

DESVENLAFAXINE - DESVENLAFAXINE TABLET, EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESVENLAFAXINE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESVENLAFAXINE.
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 IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.4) 7/2023
INDICATIONS AND USAGE
Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for the treatment of
adults with major depressive disorder (MDD) (1). (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
Desvenlafaxine extended-release tablets are available as 50 and 100 mg
tablets (3) (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 disorders with
desvenlafaxine or within 7 days of stopping treatment with
desvenlafaxine. Do not use desvenlafaxine
withi