VIIBRYD- vilazodone hydrochloride tablet VIIBRYD- vilazodone hydrochloride kit

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

VILAZODONE HYDROCHLORIDE (UNII: U8HTX2GK8J) (VILAZODONE - UNII:S239O2OOV3)

Pieejams no:

Allergan, Inc.

SNN (starptautisko nepatentēto nosaukumu):

VILAZODONE HYDROCHLORIDE

Kompozīcija:

VILAZODONE HYDROCHLORIDE 10 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

VIIBRYD®  is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. VIIBRYD is contraindicated in: - Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ) , Drug Interactions ( 7 ) ] . 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 advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartu

Produktu pārskats:

VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: VIIBRYD (vilazodone HCl) Patient Starter Kits are supplied in the following configuration: Store tablets at 25o C (77°F). Excursions permitted to 15o C - 30o C (59°F - 86°F) [see USP Controlled Room Temperature ].

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

VIIBRYD- VILAZODONE HYDROCHLORIDE
Allergan, Inc.
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MEDICATION GUIDE
VIIBRYD® (vī-brid)
(vilazodone hydrochloride)
Tablets, for oral use
What is the most important information I should know about VIIBRYD?
VIIBRYD may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions in some children,
adolescents, and young adults.
VIIBRYD and other antidepressant medicines may increase suicidal
thoughts or actions in some
people 24 years of age and younger, especially within the first few
months of treatment or when
the dose is changed. VIIBRYD is not for use in children.
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts or actions. Some people may have a higher risk of having
suicidal thoughts or
actions. These include people who have (or have a family history of)
depression, bipolar
illness (also called manic-depressive illness) or have a history of
suicidal thoughts or
actions.
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, or if you develop suicidal thoughts or actions. 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 or get emergency medical help right away
if you or your family member
have any of the following symptoms, especially if they are new, worse,
or worry you:
•
attempts to commit suicide
•
acting aggressive, being angry or violent
•
new or worse depression
•
panic attacks
•
new or worse irritability
•
an extreme increase in activity or talking
(mania)
•
acting on dangerous impulses
•
thoughts about suicide

Produkta apraksts

VIIBRYD- VILAZODONE HYDROCHLORIDE TABLET
VIIBRYD- VILAZODONE HYDROCHLORIDE
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIIBRYD SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIIBRYD.
VIIBRYD (VILAZODONE HYDROCHLORIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANTIDEPRESSANTS INCREASE THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PEDIATRIC
AND YOUNG ADULT PATIENTS (5.1).
CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL
WORSENING AND
EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1).
VIIBRYD IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.3) 8/2023
INDICATIONS AND USAGE
VIIBRYD is indicated for the treatment of major depressive disorder
(MDD) in adults (1).
DOSAGE AND ADMINISTRATION
Recommended target dosage: 20 mg to 40 mg once daily with food (2.1,
12.3)
To titrate: start with initial dosage of 10 mg once daily for 7 days,
followed by 20 mg once daily. The
dose may be increased up to 40 mg once daily after a minimum of 7 days
between dosage increases
(2.1)
Prior to initiating VIIBRYD, screen for bipolar disorder (2.2, 5.4)
When discontinuing VIIBRYD, reduce dosage gradually (2.4, 5.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs (4)
WARNINGS AND PRECAUTIONS
Serotonin Syndrome: Increased risk when co-administered with other
serotonergic agents, but also
when taken alone. If it occurs, discontinue VIIBRYD and serotonergic
agents and initiate supportive
treatment (5.2)
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal
anti-inflammatory drugs (NSAIDs),
other antiplatelet drugs, warfarin, and other anticoagulants may
increase this risk (5.3)
Activation of Mania/Hypomania: Screen patie