VILAZODONE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NorthStar RxLLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] . Vilazodone hydrochloride tablets are 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)]. 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 (

Ringkasan produk:

Vilazodone hydrochloride tablets are supplied in the following configurations with a child-resistant closure: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET
NorthStar RxLLC
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MEDICATION GUIDE
Vilazodone Hydrochloride Tablets,
[Vil-AZ-oh-done HYE-droe-KLOR-ide]
for oral use
What is the most important information I should know about vilazodone
hydrochloride tablets?
Vilazodone hydrochloride tablets may cause serious side effects,
including:
•
Increased risk of suicidal thoughts or actions in some children,
adolescents, and young adults.
Vilazodone hydrochloride tablets 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 hydrochloride
tablets are 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
•
acting on dangerous impulses
•
thoughts about su

Karakteristik produk

VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET
NORTHSTAR RXLLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VILAZODONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
VILAZODONE HYDROCHLORIDE TABLETS.
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).
VILAZODONE HYDROCHLORIDE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS
( 8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (
5.9) 7/2021
INDICATIONS AND USAGE
Vilazodone hydrochloride tablets are 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 hydrochloride tablets, screen for
bipolar disorder ( 2.2, 5.4)
When discontinuing vilazodone hydrochloride tablets, 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
hydrochloride tablets and initiate supportive treatment ( 5.2)
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroida