Vilazodone Hydrochloride

• Major depressive disorder

Vilazodone Hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults.

N/A

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.

The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

CYP3A4 Inhibitors: The vilazodone dose should not exceed 20 mg once daily when coadministered with strong CYP3A4 inhibitors.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).

Suicidal Thoughts and Behaviors in Adolescents and Young Adults Serotonin Syndrome Increased Risk of Bleeding Activation of Mania or Hypomania Discontinuation Syndrome Seizures Angle-Closure Glaucoma Hyponatremia Sexual Dysfunction

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. There are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production. 

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.Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk.Activation of Mania/Hypomania: Screen patients for bipolar disorder.Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder.Angle Closure Glaucoma: Avoid use of antidepressants, including vilazodone, in patients with untreated anatomically narrow angles.Sexual Dysfunction: vilazodone may cause symptoms of sexual dysfunction.

Pediatric Use: The safety and effectiveness of Vilazodone have not been established in pediatric patients for the treatment of MDD.Geriatric Use: Based on a pharmacokinetic study, no dosage adjustment of Vilazodone is recommended on the basis of age. Results from pharmacokinetic study of a single 20 mg Vilazodone dose in geriatric subjects (>65 years-old) vs. younger subjects (24-55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups.