Vilazodone Hydrochloride (Viibryd)

Trade Name : VIIBRYD

Allergan, Inc.

KIT

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Vilazodone Hydrochloride (Viibryd) which is also known as VIIBRYD and Manufactured by Allergan, Inc.. It is available in strength of per ml. Read more

Vilazodone Hydrochloride (Viibryd) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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Antidepressants increased the risk of suicidal thoughts and behavin- ors in pediatric andn- young adultn- patientsn- in short-term studies. n- Closely monitor all antidepressant-treated patients n- for clinical worsening and for emergence of suicidal thoughts and behaviors n- [see Warnings and Precautions (n- Arrayn- )n- ]. Viibryd is not approved for use in pediatric patients [seen- u00a0n- Use in Specific Populations (n- Arrayn- )].
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.

Antidepressants increase the risk of suicidal thoughts and behaviors inn- pediatric and young adultn- patients (n- Arrayn- ).
Closelyn- monitor all antidepressant-treated patients n- for clinical worsening and emergence of suicidal thoughts and behaviors (n- Arrayn- ).
Viibryd is n- not n- approved for usen- u00a0n- in pediatric patients (n- Arrayn- ).

VIIBRYDu00a0isu00a0indicated for the treatment of major depressive disorder (MDD) in adultsu00a0n n n
VIIBRYD is indicated for the treatment of major depressive disorder (MDD) in adultsu00a0().

No data

Recommended target dosage:u00a020 mg tou00a040 mg once daily with food (, )n
To titrate: startu00a0with 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 ()n
Prior to initiating VIIBRYD, screen for bipolar disorder (, )n
When discontinuing VIIBRYD, reduce dosage gradually (, )

VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg film-coated tablets.
10 mg pink, oval tablet, debossed with 10 on one side20 mg orange, oval tablet, debossed with 20 on one side40 mg blue, oval tablet, debossed with 40 on one side
Tablets: 10 mg, 20 mg, and 40 mg ()

VIIBRYD is contraindicated in:

Concomitant use of monoamine oxidase inhibitors (MAOIs),u00a0or use within 14 days of stopping MAOIs ()

No data

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans, amphetamines),u00a0but also when taken alone. If it occurs, discontinue VIIBRYD and initiate supportive treatment () n
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ()n
Activation of Mania/Hypomania: Screen patients for bipolar disorder ().n
Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder ().n
Angle Closure Glaucoma: Avoid use of antidepressants, including VIIBRYD, in patients with untreated anatomically narrow angles. ()

The following adverse reactions are discussed in greater detail in other sections of the labeling:
Most common adverse reactions (incidence u2265 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia ().

No data

CYP3A4 Inhibitors: The VIIBRYD dose should not exceed 20 mg once dailyu00a0whenu00a0co-administered with strong CYP3A4 inhibitors (, ).n
CYP3A4 Inducers: Consider increasing VIIBRYD dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducersu00a0for greater than 14 days (, ).

No data

Pregnancy:u00a0Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newbornu00a0().

No data

There is limited clinical trial experience regarding human overdose with VIIBRYD. The adverse reactions associated with overdose of VIIBRYD at doses of 200-280 mg (5 to 7 times the recommended dosage) as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation.
For current information on the management of poisoning or overdose, contact a poison control center at 1-800-222-1222.
No specific antidotes for vilazodone are known.u00a0Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.

VIIBRYDu00a0tabletsu00a0for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HTu00a0receptor partial agonist.
Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is:
VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively.
In addition to the active ingredient, VIIBRYDu00a0tablets contain the following inactive ingredients:u00a0colloidal silicon dioxide,u00a0lactose monohydrate, magnesium stearate, microcrystalline cellulose,u00a0polyethylene glycol,u00a0polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).

No data

Carcinogenesis
Carcinogenicity studies were conducted inu00a0which B6C3F1mice andu00a0Wistar ratsu00a0were given oral doses of vilazodone up to 135 and 150 mg/kg/day, respectively, for 2 years. These doses are approximately 16.5 and 36 times the maximum recommended human dose (MRHD) of 40 mg, respectively, on a mg/m basis.
In mice, the incidence of hepatocellular carcinomas was increased in males at 16.5 times the MRHD; this finding was not observed at 5.5 times the MRHD.u00a0The incidence of malignant mammary gland tumorsu00a0wasu00a0numerically increased in females at 5.5 and 16.5 times the MRHD,u00a0with statistical significance at 16.5 the MRHD; this finding was not observed at 1.8 times the MRHD. Elevated prolactin levels were observed in a 2-week study of vilazodone administered at 5.5 and 33 times the MRHD. Increases in prolactin levels are known to cause mammary tumors in rodents.
In the rat study, vilazodone was not carcinogenic in either sex at doses up to 36 times the MRHD.
Mutagenesis
Vilazodone was not mutagenic in the u00a0bacterial reverse mutation assay (Ames test). Vilazodone was negative in the V79/HGRPT mammalian cell forward mutation assay. Vilazodone was clastogenic in twou00a0 mammalian cell chromosome aberration assays. However, vilazodone was negative for clastogenic activity in both an rat bone marrow chromosome aberration assay and a micronucleus test. Vilazodone was also negative in an n n n unscheduled DNA synthesis assay in rats.
Impairment of Fertility
Treatment of rats with vilazodone at a dose of 125 mg/kg, which is 30 times the MRHD of 40 mg on a mg/m basis, caused impairment of male fertility with no effect on female fertility. Impaired male fertility was not observed atu00a06 times the MRHD.

The efficacy of VIIBRYD as a treatment for major depressive disorder was demonstrated in fouru00a0multicenter, randomized, double-blind, placebo-controlled studies in adult (18-70 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD.u00a0Three 8-week studies evaluated the efficacy of VIIBRYD 40 mg (Studies 1-3) and one 10-week study (Study 4) evaluated the efficacy of VIIBRYD 20 mg and 40 mg (see Table 5). In these studies, patients were randomized to either 20 mg or 40 mg, or placebo onceu00a0daily with food.u00a0Patients were either titrated over 1week to a dose of 20 mg daily or over 2 weeks to a dose of 40 mg once daily of VIIBRYD with food. VIIBRYD was superior to placebo in the improvement of depressive symptoms as measured by theu00a0change from baseline to endpoint visit in the Montgomery-Asberg Depression Rating Scale (MADRS) total score for both doses.u00a0The MADRS is a ten-item, clinician-rated scale used to assess severity of depressive symptoms. Scores on the MADRS range from 0 to 60, with higher scores indicating more severe depression.u00a0Clinical Global Impressionu00a0- Severity (CGI-S) was evaluated in Studies 3 and 4. VIIBRYD 20 mg and 40 mg demonstrated superiority over placebo as measured by improvement in CGI-S score.
SD = standard deviation; SE = standard error; LS Mean = least-square mean; CI = confidence interval
* All VIIBRYD treatment dose groups remained statistically significant compared with placebo after adjusting for multiplicity
Baseline demographics information were generally similar across all treatment groups.u00a0Examination of population subgroups based on age (there were few patients over 65), gender and race did not reveal any clear evidence of differential responsiveness.n

VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations:
VIIBRYD (vilazodone HCl) Patient Starter Kits are supplied in the following configuration:
Store tablets at 25C (77u00b0F). Excursions permitted to 15C - 30C (59u00b0F - 86u00b0F) [].

Advise the patient to read the FDA-approved patient labeling ().
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provideru00a0n n n n n
Dosn- agen- and Administration
Instruct patients to take VIIBRYD with food and to follow prescribed dosage instructionsu00a0n n n n n n n n n
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of VIIBRYDu00a0with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone,u00a0amphetamines, and St. Johnu2019s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms ofu00a0serotonin syndrome n n n n n
Increased Risk of Bleeding
Inform patients about the concomitant use of VIIBRYDu00a0withu00a0aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulantsu00a0because the combined use of drugs that interfere with serotonin reuptake (e.g., VIIBRYD) and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleedingu00a0n n n
Activation of Mania/Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provideru00a0n n n
Discontinuation Syndrome
Advise patients not to abruptly discontinue VIIBRYD and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when VIIBRYD is discontinued n n n
Seizures
Caution patients about using VIIBRYD if they have a history of a seizure disorder n n n
Allergic Reactions
Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathingu00a0n n n n n n n n
Concomitant Medications
Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactionsu00a0n n n
Pregnancy
Distributed byAllergan USA, Inc.Madison, NJ 07940
Licensed from Merck KGaA,Darmstadt, Germany
VIIBRYD is a registered trademark of Allergan Sales, LLC. u00a0
u00a9 2020u00a0Allergan. All rights reserved.
All trademarks are the property of their respective owners.Patented. See www.allergan.com/patentsv2.0USPI1110

This Medication Guide has been approved by the U.S. Food and Drug Administration. u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt Revised:u00a001/2020
v2.0MG1110

NDC 0456-1110-30Viibrydvilazodone HCItablets30 Tablets10 mgRx Only

NDC 0456-1120-30Viibrydvilazodone HCItablets30 Tablets20 mgRx Only

NDC 0456-1140-30Viibrydvilazodone HCItablets30 Tablets40 mgRx Only

NDC 0456-1100-31Viibrydvilazodone HCI tablets10 mgDays 1-720 mgDays 8-1440 mgDays 15-30Rx Only

NDC 0456-1101-30Viibrydvilazodone HCI tablets10 mgDays 1-720 mgDays 8-30Rx Only

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Vilazodone Hydrochloride (Viibryd)

Trade Name : VIIBRYD

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Vilazodone Hydrochloride (Viibryd)

Trade Name : VIIBRYD

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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