VILAZODONE HYDROCHLORIDE tablet, film coated VILAZODONE HYDROCHLORIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Cipla USA Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Vilazodone hydrochloride tablets are supplied in the following configurations: 10 mg - pink, film coated, elliptical shaped biconvex tablets debossed with “IG ” on one side and “544 ” on the other, supplied in bottle of 30 (NDC 69097-979-02). 20 mg, orange, film coated, elliptical shaped biconvex tablets debossed with “IG ” on one side and “545 ” on the other, supplied in bottle of 30 (NDC 69097-981-02). 40 mg, blue, film coated, Elliptical shaped biconvex tablets debossed with “IG ” on one side and “546 ” on other, supplied in bottle of 30 (NDC 69097-982-02). Vilazodone hydrochloride tablets should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED
VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED
Cipla USA Inc.
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MEDICATION GUIDE
Vilazodone Hydrochloride Tablets,
[Vil-AZ-oh-done]
Tablets, 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 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, bein

Fachinformation

VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED
VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED
CIPLA USA INC.
----------
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 TABLETS IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (8.4).
INDICATIONS AND USAGE
Vilazodone hydrochloride 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 hydrochloride, screen for bipolar
disorder (2.2, 5.4)
When discontinuing vilazodone hydrochloride, 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 and initiate supportive treatment (5.2)
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal
anti-inflamm