BRINTELLIX- vortioxetine tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

VORTIOXETINE HYDROBROMIDE (UNII: TKS641KOAY) (VORTIOXETINE - UNII:3O2K1S3WQV)

Mevcut itibaren:

Takeda Pharmaceuticals America, Inc.

INN (International Adı):

VORTIOXETINE HYDROBROMIDE

Kompozisyon:

VORTIOXETINE 5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

BRINTELLIX is indicated for the treatment of major depressive disorder (MDD). The efficacy of BRINTELLIX was established in six 6 to 8 week studies (including one study in the elderly) and one maintenance study in adults [see Clinical Studies (14)] . Pregnancy Category C Risk Summary There are no adequate and well-controlled studies of BRINTELLIX in pregnant women. Vortioxetine caused developmental delays when administered during pregnancy to rats and rabbits at doses 15 and 10 times the maximum recommended human dose (MRHD) of 20 mg, respectively. Developmental delays were also seen after birth in rats at doses 20 times the MRHD of vortioxetine given during pregnancy and through lactation. There were no teratogenic effects in rats or rabbits at doses up to 77 and 58 times, the MRHD of vortioxetine, respectively, given during organogenesis. The incidence of malformations in human pregnancies has not been established for BRINTELLIX. All human pregnancies, regardless of drug exposure, have a background rate of

Ürün özeti:

BRINTELLIX tablets are available as follows: Features Strengths 5 mg 10 mg 15 mg 20 mg Color pink yellow orange red Debossment “5” on one side of tablet “TL” on other side of tablet “10” on one side of tablet “TL” on other side of tablet “15” on one side of tablet “TL” on other side of tablet “20” on one side of tablet “TL” on other side of tablet Presentations and NDC Codes Bottles of 30 64764-550-30 64764-560-30 64764-570-30 64764-580-30 Bottles of 90 64764-550-90 64764-560-90 64764-570-90 64764-580-90 Bottles of 500 64764-550-77 64764-560-77 64764-570-77 64764-580-77 Storage: Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

BRINTELLIX- VORTIOXETINE TABLET, FILM COATED
Takeda Pharmaceuticals America, Inc.
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MEDICATION GUIDE
BRINTELLIX [brin’-tel-ix]
(vortioxetine) Tablets
Read this Medication Guide before you start taking BRINTELLIX 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 your treatment.
What is the most important information I should know about BRINTELLIX?
BRINTELLIX and other antidepressant medicines may cause serious side
effects.
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, or
young adults within the first few months of treatment.
2.
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
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,
behavior, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
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 right away if you have any of the
following symptoms, especially if they
are new, worse, or worry you:
•
attempts to commit suicide
•
trouble sleeping
•
acting on dangerous impulses
•
an extreme increase in activity or talking
(mania)
•
acting aggressive, being angry or violent
•
other unusual changes in behavior or mood
•
•
thoughts about suicide or dying
panic

Ürün özellikleri

BRINTELLIX- VORTIOXETINE TABLET, FILM COATED
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRINTELLIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BRINTELLIX.
BRINTELLIX (VORTIOXETINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 7/2014
INDICATIONS AND USAGE
BRINTELLIX is indicated for the treatment of major depressive disorder
(MDD) (1, 14).
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
BRINTELLIX is available as 5 mg, 10 mg, 15 mg, and 20 mg immediate
release tablets (3).
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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).
BRINTELLIX HAS NOT BEEN EVALUATED FOR USE IN PEDIATRIC PATIENTS (8.4).
The recommended starting dose is 10 mg administered orally once daily
without regard to meals (2.1).
The dose should then be increased to 20 mg/day, as tolerated (2.1).
Consider 5 mg/day for patients who do not tolerate higher doses (2.1).
BRINTELLIX can be discontinued abruptly. However, it is recommended
that doses of 15 mg/day or 20 mg/day be
reduced to 10 mg/day for one week prior to full discontinuation if
possible (2.3).
The maximum recommended dose is 10 mg/day in known CYP2D6 poor
metabolizers (2.6).
Hypersensitivity to vortioxetine or any components of the BRINTELLIX
formulation (4).
Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to
treat psychiatric disorders with
BRINTELLIX or within 21 days of stopping treatment with BRINTELLIX. Do
not use BRINTELLIX within 14 days of
stopping an MAOI intended to treat psychiatric disorders. In addition,
do not start BRINTELLIX in