Viibryd
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Uses
VIIBRYD® is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, randomized, double-blind, placebo-controlled trials in adult patients with a diagnosis of MDD [see Clinical Studies (14)].
Major depressive disorder consists of one or more major depressive episodes. A major depressive episode (DSM-IV-TR) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
History
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Other Information
VIIBRYD Tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist.
Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is:
In addition to the active ingredient, VIIBRYD Tablets contain lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only) and FD&C Red #40 (10 mg only).
Sources
Viibryd Manufacturers
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Cardinal Health
![Viibryd (Vilazodone Hydrochloride) Tablet [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Viibryd | Salado Sales, Inc.
do not use more than directed drink a full glass of water with each dose adults and children 12 years and over take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor -
Forest Laboratories, Inc.
Viibryd | Forest Laboratories, Inc.
2.1 Dosage for Treatment of Major Depressive DisorderThe recommended target dosage for VIIBRYD is 20 mg to 40 mg orally once daily with food [see Clinical Pharmacology (12.3), Clinical Studies (14)]. To achieve the target dosage, titrate VIIBRYD as follows:
Start with an initial dosage of 10 mg once daily with food for 7 days, Then increase to 20 mg once daily with food. The dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases.If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.
2.2 Screen for Bipolar Disorder Prior to Starting VIIBRYDPrior to initiating treatment with VIIBRYD or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)].
2.3 Switching to or from a Monoamine Oxidase Inhibitor AntidepressantAt least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of VIIBRYD. In addition, at least 14 days must elapse after stopping VIIBRYD before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].
2.4 Dosage Adjustments with CYP3A4 Inhibitors or InducersPatients receiving concomitant CYP3A4 inhibitors:
During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the VIIBRYD dose should not exceed 20 mg once daily. The original VIIBRYD dose level, can be resumed when the CYP3A4 inhibitor is discontinued [see Drug Interactions (7)].
Patients receiving concomitant CYP3A4 inducers:
Based on clinical response, consider increasing the dosage of VIIBRYD by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the VIIBRYD dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)].
2.5 Discontinuing Treatment with VIIBRYDAdverse reactions may occur upon discontinuation of VIIBRYD [see Warnings and Precautions (5.5)]. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. VIIBRYD should be down tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking VIIBRYD 20 mg once daily should be tapered to 10 mg once daily for 7 days.
![Viibryd (Vilazodone Hydrochloride) Tablet Viibryd (Vilazodone Hydrochloride) Kit [Forest Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4c55ccfb-c4cf-11df-851a-0800200c9a66&name=vii00-0013-05.jpg)
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