WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

Vilazodone hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Treatment of Major Depressive Disorder

The recommended target dosage for vilazodone hydrochloride 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 tablets 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

Prior to initiating treatment with vilazodone hydrochloride 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. In addition, at least 14 days must elapse after stopping vilazodone hydrochloride 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 dose should not exceed 20 mg once daily. The original vilazodone hydrochloride 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 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 dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)].

2.5 Discontinuing Treatment with Vilazodone Hydrochloride

Adverse reactions may occur upon discontinuation of vilazodone hydrochloride [see Warnings and Precautions (5.5)] . A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Vilazodone hydrochloride 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 20 mg once daily should be tapered to 10 mg once daily for 7 days.