Vilazodone Hydrochloride
Generic Name: vilazodone hydrochloride
Brand Names:
Vilazodone, Vilazodone
11 DESCRIPTION VILAZODONE tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT 1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1 H -indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99.
Overview
11 DESCRIPTION VILAZODONE tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT 1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1 H -indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99.
Uses
1 INDICATIONS AND USAGE Vilazodone is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Vilazodone is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Dosage
2 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 ) 2.1 Dosage for Treatment of Major Depressive Disorder The recommended target dosage for vilazodone is 20 mg to 40 mg orally once daily with food [ see Clinical Pharmacology ( 12.3 ) , Clinical Studies ( 14 ) ] .
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )]. Serotonin Syndrome [see Warnings and Precautions ( 5.2 )]. Increased Risk of Bleeding [see Warnings and Precautions ( 5.3 )]. Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )]. Discontinuation Syndrome [see Warnings and Precautions ( 5.5 )]. Seizures [see Warnings and Precautions ( 5.6 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )]. Hyponatremia [see Warnings and Precautions ( 5.8 )]. Sexual Dysfunction [see Warnings and Precautions ( 5.9 )].
Interactions
7 DRUG INTERACTIONS CYP3A4 Inhibitors: The Vilazodone dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors ( 2.4 , 7 ). CYP3A4 Inducers: Consider increasing Vilazodone dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days ( 2.4 , 7 ). 7.1 Drugs Having Clinically Important Interactions With V ilazodone Table 4: Clinically Important Drug Interactions with Vilazodone Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of MAOIs and serotonergic drugs including vilazodone increases the risk of serotonin syndrome.
Warnings
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Vilazodone is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . 5 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 patients for bipolar disorder ( 5.4 ). Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder ( 5.6 ). Angle Closure Glaucoma: Avoid use of antidepressants, including Vilazodone, in patients with untreated anatomically narrow angles. 4 CONTRAINDICATIONS 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
8.1 Pregnancy 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Vilazodone tablets are supplied in the following configurations: Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code 10 mg pink, oval tablet debossed with 10 on one side Bottle / 30 count 42291-948-30 20 mg orange, oval tablet debossed with 20 on one side Bottle / 30 count 42291-949-30 40 mg blue, oval tablet debossed with 40 on on...
Frequently Asked Questions
What is Vilazodone Hydrochloride used for?▼
1 INDICATIONS AND USAGE Vilazodone is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Vilazodone is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
What are the side effects of Vilazodone Hydrochloride?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )]. Serotonin Syndrome [see Warnings and Precautions ( 5.2 )]. Increased Risk of Bleeding [see Warnings and Precautions ( 5.3 )]. Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )]. Discontinuation Syndrome [see Warnings and Precautions ( 5.5 )]. Seizures [see Warnings and Precautions ( 5.6 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )]. Hyponatremia [see Warnings and Precautions ( 5.8 )]. Sexual Dysfunction [see Warnings and Precautions ( 5.9 )].
Can I take Vilazodone Hydrochloride during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Vilazodone Hydrochloride?▼
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Vilazodone is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . 5 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 patients for bipolar disorder ( 5.4 ). Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder ( 5.6 ). Angle Closure Glaucoma: Avoid use of antidepressants, including Vilazodone, in patients with untreated anatomically narrow angles. 4 CONTRAINDICATIONS 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 ) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.