DESVENLAFAXINE- desvenlafaxine succinate tablet, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Lake Erie Medical DBA Quality Care Products LLC

INN (Isem Internazzjonali):

DESVENLAFAXINE SUCCINATE

Kompożizzjoni:

DESVENLAFAXINE 50 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14) and Dosage and Administration (2.1)] . The efficacy of desvenlafaxine has been established in four short-term (8-week, placebo-controlled studies) and two maintenance studies in adult outpatients who met DSM-IV criteria for major depressive disorder. - Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine 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 (2.6) and

Sommarju tal-prodott:

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. 100 mg, dark brown to red colored, round, biconvex tablets, debossed with ‘L350’ on one side and plain on other side. 55700-577-30 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 76 mg or 152 mg of desvenlafaxine succinate equivalent to  50 mg or 100 mg of desvenlafaxine, respectively.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Desvenlafaxine Extended-Release Tablets
(des VEN la FAX een)
Read this Medication Guide before you start taking desvenlafaxine and
each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Talk to your healthcare provider about:
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental
illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions
in some children, teenagers, and
young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and
actions.Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
3. 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 a healthcare provider right away if you have any of the following
symptoms, especially if they are
new, worse, or worry you:

Karatteristiċi tal-prodott

DESVENLAFAXINE- DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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 RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.1).
• MONITOR FOR 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 – Serotonin Syndrome (5.2) 1/2017
INDICATIONS AND USAGE
Desvenlafaxine, is a serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for the treatment of 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
(2.2). (2)
DOSAGE FORMS AND STRENGTHS
Desvenlafaxine extended-release tablets are available as 50 mg and 100
mg (3).
Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate
equivalent to 50 mg or 100 mg