Vilazon Tablet

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-HT_1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

Dosage for Treatment of Major Depressive Disorder: The recommended target dosage for vilazodone is 20 mg to 40 mg orally once daily with food. To achieve the target dosage, titrate vilazodone 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.

Screen for Bipolar Disorder Prior to Starting vilazodone: Prior to initiating treatment with vilazodone or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

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. In addition, at least 14 days must elapse after stopping vilazodone before starting an MAOI antidepressant.

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 dose should not exceed 20 mg once daily. The original vilazodone dose level, can be resumed when the CYP3A4 inhibitor is discontinued.
• Patients receiving concomitant CYP3A4 inducers: Based on clinical response, consider increasing the dosage of vilazodone 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 dosage to its original level over 1 to 2 weeks.

Discontinuing Treatment with vilazodone: Adverse reactions may occur upon discontinuation of vilazodone. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. vilazodone 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 20 mg once daily should be tapered to 10 mg once daily for 7 days.

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).

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.

• 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 Vilazon have not been established in pediatric patients for the treatment of MDD.

Geriatric Use: Based on a pharmacokinetic study, no dosage adjustment of Vilazon is recommended on the basis of age. Results from pharmacokinetic study of a single 20 mg Vilazon 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.

Atypical anti-depressant drugs

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.