VILAZODONE HYDROCHLORIDE
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
0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf
HUMAN PRESCRIPTION DRUG LABEL
Jan 30, 2023
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VILAZODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
VILAZODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
VILAZODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-40 mg
NDC 46708-234-30
** Vilazodone**
Hydrochloride Tablets
40 mg
** PHARMACIST: Dispense the accompanying**
** Medication Guide to each patient.**
** Rx only**
** 30 Tablets**
****Alembic
**
**
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Treatment of Major Depressive Disorder
The recommended target dosage for vilazodone hydrochloride tablet 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 vilazodone hydrochloride tablet 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 Vilazodone Hydrochloride
Tablets
Prior to initiating treatment with vilazodone hydrochloride tablet 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 Antidepressant
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of vilazodone hydrochloride tablet. In addition, at least 14 days must elapse after stopping vilazodone hydrochloride tablet before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].
2.4 Dosage Adjustments with CYP3A4 Inhibitors or Inducers
Patients receiving concomitant CYP3A4 inhibitors:
During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the vilazodone hydrochloride tablet dose should not exceed 20 mg once daily. The original vilazodone hydrochloride tablet 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 vilazodone hydrochloride tablets 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 vilazodone hydrochloride tablet dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)].
2.5 Discontinuing Treatment with Vilazodone Hydrochloride Tablets
Adverse reactions may occur upon discontinuation of vilazodone hydrochloride tablet [see Warnings and Precautions (5.5)]. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Vilazodone hydrochloride tablet 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 vilazodone hydrochloride tablet 20 mg once daily should be tapered to 10 mg once daily for 7 days.
• 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 tablets, screen for bipolar
disorder (2.2, 5.4).
• When discontinuing vilazodone hydrochloride tablets, reduce the dosage
gradually (2.4, 5.5). (2)
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis,Impairment of Fertility
Carcinogenesis
Carcinogenicity studies were conducted in which B6C3F1mice and Wistar rats were 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/m2 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. The incidence of malignant mammary gland tumors was numerically increased in females at 5.5 and 16.5 times the MRHD, with 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 in vitro bacterial reverse mutation assay (Ames test). Vilazodone was negative in the in vitro V79/HGRPT mammalian cell forward mutation assay. Vilazodone was clastogenic in two in vitro mammalian cell chromosome aberration assays. However, vilazodone was negative for clastogenic activity in both an in vivo rat bone marrow chromosome aberration assay and a micronucleus test. Vilazodone was also negative in an in vivo/in vitro 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/m2 basis, caused impairment of male fertility with no effect on female fertility. Impaired male fertility was not observed at 6 times the MRHD.
CLINICAL STUDIES SECTION
14 CLINICAL STUDIES
The efficacy of vilazodone hydrochloride tablets as a treatment for major depressive disorder was demonstrated in four multicenter, randomized, double- blind, placebo-controlled studies in adult (18 to 70 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. Three 8-week studies evaluated the efficacy of vilazodone hydrochloride tablets 40 mg (Studies 1 to 3) and one 10-week study (Study 4) evaluated the efficacy of vilazodone hydrochloride tablets 20 mg and 40 mg (see Table 5). In these studies, patients were randomized to either 20 mg or 40 mg, or placebo once daily with food. Patients 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 vilazodone hydrochloride tablets with food. Vilazodone hydrochloride tablet was superior to placebo in the improvement of depressive symptoms as measured by the mean change from baseline to endpoint visit in the Montgomery-Asberg Depression Rating Scale (MADRS) total score for both doses. The 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. Clinical Global Impression - Severity (CGI-S) was evaluated in Studies 3 and 4. Vilazodone hydrochloride tablets 20 mg and 40 mg demonstrated superiority over placebo as measured by improvement in CGI-S score.
Table 5: Summary of Results for the Primary Efficacy Endpoint - MADRS Total Score
|
Study Number |
Treatment Group |
Number of Patients**a** |
Mean Baseline Score (SD) |
LS Mean Change from Baseline (SE) |
Placebo-subtracted Differenceb(95% CI) |
|
Study 1 |
Vilazodone hydrochloride tablets 40 mg/day |
198 |
30.8 (3.9) |
-12.9 (0.77) |
-3.2 (-5.2, -1.3) |
|
Placebo |
199 |
30.7 (3.93) |
-9.6 (0.76) | ||
|
Study 2 |
Vilazodone hydrochloride tablets |
231 |
31.9 (3.5) |
-13.3 (0.9) |
-2.5 (-4.4, -0.6) |
|
Placebo |
232 |
32 (3.63) |
-10.8 (0.9) | ||
|
Study 3 |
Vilazodone hydrochloride tablets |
253 |
30.7 (3.3) |
-16.1 (0.64) |
-5.1 (-6.9, -3.3) |
|
Placebo |
252 |
30.9 (3.3) |
-11 (0.65) | ||
|
Study 4 |
Vilazodone hydrochloride tablets |
288 |
31.3 (3.5) |
-17.3 (0.63) |
-2.6 (-4.3, -0.8) |
|
Vilazodone hydrochloride tablets |
284 |
31.2 (3.8) |
-17.6 (0.65) |
-2.8 (-4.6, -1.1) | |
|
Placebo |
281 |
31.4 (3.8) |
-14.8 (0.62) |
SD = standard deviation; SE = standard error; LS Mean = least-square mean; CI
= confidence interval
abased on patients who took study medication and had baseline and postbaseline
MADRS assessments
bdifference (drug minus placebo) in least-square mean change from baseline to endpoint
*All vilazodone hydrochloride tablets treatment dose groups remained statistically significant compared with placebo after adjusting for multiplicity
Baseline demographics information were generally similar across all treatment groups. Examination of population subgroups based on age (there were few patients over 65), gender and race did not reveal any clear evidence of differential responsiveness.
SPL MEDGUIDE SECTION
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MEDICATION GUIDE |
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What is the most important information I should know about vilazodone hydrochloride tablets? ** Vilazodone hydrochloride tablets may cause serious side effects,
including:****** |
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What is vilazodone hydrochloride tablet? |
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Who should not take vilazodone hydrochloride tablets? |
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Before taking vilazodone hydrochloride tablets, tell your healthcare
provider about all your medical conditions, including if you:• have or have
a family history of suicide, depression, bipolar disorder, mania or hypomania |
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How should I take vilazodone hydrochloride tablets? |
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What should I avoid while taking****vilazodone hydrochloride tablets? |
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What are the possible side effects of****vilazodone hydrochloride tablets?
** ** •Increased risk of bleeding.**Taking vilazodone hydrochloride tablets with
aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin or blood
thinners may add to this risk. Tell your healthcare provider right away about
any unusual bleeding or bruising. **•Discontinuation syndrome.**Suddenly stopping vilazodone hydrochloride
tablets may cause you to have serious side effects. Your healthcare provider
may want to decrease your dose slowly. Symptoms may include: ** •Eye problems (angle-closure glaucoma):**Vilazodone hydrochloride tablets
may cause a certain type of eye problem called angle-closure glaucoma. Call
your healthcare provider if you have changes in your vision or eye pain. Symptoms in females may include: |
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How should I store****vilazodone hydrochloride tablets? |
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General information about the safe and effective use ofvilazodone
hydrochloride tablets. |
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What are the ingredients in vilazodone hydrochloride tablets? Manufactured by: All trademarks are the property of their respective owners. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 01/2022