Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
VILAZODONE HYDROCHLORIDE (UNII: U8HTX2GK8J) (VILAZODONE - UNII:S239O2OOV3)
Golden State Medical Supply, Inc.
ORAL
PRESCRIPTION DRUG
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
Vilazodone tablets are supplied in the following configurations: Store tablets at 25 o C (77°F). Excursions permitted to 15 o C - 30 o C (59°F - 86°F) [ see USP Controlled Room Temperature ].
New Drug Application Authorized Generic
VILAZODONE- VILAZODONE HYDROCHLORIDE TABLET Golden State Medical Supply, Inc. ---------- 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 suic Lesen Sie das vollständige Dokument
VILAZODONE- VILAZODONE HYDROCHLORIDE TABLET VILAZODONE- VILAZODONE HYDROCHLORIDE TABLET GOLDEN STATE MEDICAL SUPPLY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION VILAZODONE THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VILAZODONE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VILAZODONE. VILAZODONETABLETS, 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 pa Lesen Sie das vollständige Dokument