Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
VILAZODONE HYDROCHLORIDE (UNII: U8HTX2GK8J) (VILAZODONE - UNII:S239O2OOV3)
Exelan Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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
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 76282-544-30). 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 76282-545-30). 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 76282-546-30). Vilazodone hydrochloride tablets should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED Exelan Pharmaceuticals Inc. ---------- 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 agg Διαβάστε το πλήρες έγγραφο
VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET, FILM COATED EXELAN PHARMACEUTICALS 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 Διαβάστε το πλήρες έγγραφο