VILAZODONE- vilazodone hydrochloride tablet VILAZODONE- vilazodone hydrochloride tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Apotex Corp

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Vilazodone is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Vilazodone 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 register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary There are no adequate and well-controlled studies of vilazodone in pregnant women. The background risk of major birth defects and miscarriage for the indicated population is

Rezumat produs:

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

Statutul autorizaţiei:

New Drug Application Authorized Generic

Prospect

VILAZODONE- VILAZODONE HYDROCHLORIDE TABLET
Apotex Corp
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MEDICATION GUIDE
Vilazodone
Tablets, for oral use
What is the most important information I should know about Vilazodone?
Vilazodone may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions in some children,
adolescents, and
young adults.
Vilazodone 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. vilazodone 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 or dying
• new o

Caracteristicilor produsului

VILAZODONE- VILAZODONE HYDROCHLORIDE TABLET
VILAZODONE- VILAZODONE HYDROCHLORIDE TABLET
APOTEX CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VILAZODONE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VILAZODONE.
VILAZODONE 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).
VILAZODONE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4).
INDICATIONS AND USAGE
Vilazodone 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 Vilazodone, screen for bipolar disorder (2.2, 5.4)
When discontinuing Vilazodone, 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 (e.g., SSRI,
SNRI, triptans, amphetamines), but also when taken alone. If it
occurs, discontinue Vilazodone 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 patients for bipolar disorder
(5.4).
Seizur