DESVENLAFAXINE- desvenlafaxine succinate tablet, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Bryant Ranch Prepack

INN (nemzetközi neve):

DESVENLAFAXINE SUCCINATE

Összetétel:

DESVENLAFAXINE 100 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Desvenlafaxine Extended-Release Tablets are available as follows: 50 mg , light pink colored, round, biconvex tablets, debossed with ‘L349’ on one side and plain on other side. NDC: 63629-7525-5: 180 Tablets in a BOTTLE NDC: 63629-7525-1: 30 Tablets in a BOTTLE NDC: 63629-7525-2: 28 Tablets in a BOTTLE NDC: 63629-7525-3: 60 Tablets in a BOTTLE NDC: 63629-7525-4: 90 Tablets in a BOTTLE 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

DESVENLAFAXINE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Desvenlafaxine Extended-Release Tablets
(des VEN la FAX een)
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)
oattempts 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, venlaf

Termékjellemzők

DESVENLAFAXINE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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 IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS
(8.4).
RECENT MAJOR CHANGES
Dosage and Administration, Discontinuing Desvenlafaxine (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 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).
•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). (2)
DOSAGE FORMS AND STRENGTHS
Desvenlafaxine extended-release tabl