DESVENLAFAXINE tablet, film coated, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hikma Pharmaceuticals USA Inc.

INN (שם בינלאומי):

DESVENLAFAXINE SUCCINATE

הרכב:

DESVENLAFAXINE 25 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185. Risk Summary Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.4) and Clinical Considerations]. There are no published studies on desvenlafaxine in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see Data ). There are risks associated with untreated depression in pregnancy a

leaflet_short:

Desvenlafaxine Extended-Release Tablets 25 mg tablet is supplied as a beige film-coated, standard biconvex tablet debossed with “54” [above] “427” on one side and plain on the other side. Each tablet contains 38 mg of desvenlafaxine succinate equivalent to 25 mg of desvenlafaxine. NDC 0054-0603-13: Bottle of 30 Tablets Unit-of-use 50 mg tablet is supplied as a peach film-coated, standard biconvex tablet debossed with “54” [above] “716” on one side and plain on the other side. Each tablet contains 76 mg of desvenlafaxine succinate equivalent to 50 mg of desvenlafaxine. NDC 0054-0400-06: Bottle of 14 Tablets Unit-of-use NDC 0054-0400-13: Bottle of 30 Tablets Unit-of-use NDC 0054-0400-22: Bottle of 90 Tablets Unit-of-use NDC 0054-0400-29: Bottle of 500 Tablets NDC 0054-0400-20: Carton of 100 (10x10) Unit-Dose Tablets 100 mg tablets are supplied as orange film-coated, standard biconvex tablet debossed with “54 [above] 341” on one side and plain on the other side. Each tablet contains 152 mg of desvenlafaxine succinate equivalent to 100 mg of desvenlafaxine. NDC 0054-0401-06: Bottle of 14 Tablets Unit-of-use NDC 0054-0401-13: Bottle of 30 Tablets in Unit-of-use NDC 0054-0401-22: Bottle of 90 Tablets in Unit-of-use NDC 0054-0401-20: Carton of 100 (10x10) Unit-Dose Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The unit-of-use package is intended to be dispensed as a unit.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Desvenlafaxine Extended-Release Tablets
(des″ ven la fax′ een)
Rx only
What is the most important information I should know about
desvenlafaxine?
Desvenlafaxine 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 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?
o
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.
o
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
o
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:
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 restless o an extreme increase in activity
and talking (mania)
o
panic attacks o other unusual changes in behavior or mood
What is desvenlafaxine?
•
Desvenlafaxine is a prescription medicine used to treat adults with a
certain type of depression
called major depressive disorder (MDD). Desvenlafaxine belongs to a
class of medicines
known as serotonin and norepinephrine reuptake inhibitors (SNRIs).
Do not take desvenlafaxine if you:
•
are allergic to desvenlafaxine succinate, venlafaxine hydrochloride,
or any of the ingred

מאפייני מוצר

DESVENLAFAXINE- DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE
HIKMA PHARMACEUTICALS USA INC.
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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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.4) 8/2023
INDICATIONS AND USAGE
Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for the treatment of
adults with major depressive disorder (MDD) (1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
•
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WARNINGS AND PRECAUTIONS
•
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).
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).
Desvenlafaxine Extended-Release Tablets: 25 mg, 50 mg and 100 mg (3).
Each tablet con