DESVENLAFAXINE- desvenlafaxine tablet, film coated, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Mylan Pharmaceuticals Inc.

INN (Internationale Bezeichnung):

DESVENLAFAXINE SUCCINATE

Zusammensetzung:

DESVENLAFAXINE 50 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . 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. There are no published studies on desvenlafaxine extended-release tablets 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 and with exposure to SNRIs and SSRIs, including desvenlafaxine extended-release tablets, during pregnancy (see Clinical Considerations). In reproductive developmental studies in rats and rabbits treated with desvenlafaxine succinate, there was no evidence of

Produktbesonderheiten:

Desvenlafaxine Extended-Release Tablets are available containing 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. The 50 mg tablets are pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and DF over 50 on the other side. They are available as follows: NDC 0378-4230-93 bottles of 30 tablets NDC 0378-4230-77 bottles of 90 tablets The 100 mg tablets are dark pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and DF over 100 on the other side. They are available as follows: NDC 0378-4231-93 bottles of 30 tablets NDC 0378-4231-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Desvenlafaxine Extended-Release Tablets
(des ven′′ la fax′ een)
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?
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
attempts to commit suicide
o
new or worse depression
o
new or worse anxiety
o
feeling very agitated or restless
o
panic attacks
o
trouble sleeping (insomnia)
o
new or worse irritability
o
acting aggressive, being angry, or violent
o
acting on dangerous impulses
o
an extreme increase in activity and talking (mania)
o
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
norepinephrine reuptake
inhi

Fachinformation

DESVENLAFAXINE- DESVENLAFAXINE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS 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
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
•
•
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
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