vilazodone

Clinical summary

Indications and usage 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 and administration 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 ) ] . 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. 2.2 Screen for Bipolar Disorder Prior to Starting V ilazodone Prior to initiating treatment with vilazodone 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 t o or f rom 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 [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 dose should not exceed 20 mg once daily. The original vilazodone 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 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 [see Drug Interactions ( 7 )] . 2. 5 Discontinuing Treatment with V ilazodone Adverse reactions may occur upon discontinuation of vilazodone [see Warnings and Precautions ( 5.5 )] . 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. Warnings and cautions 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. ( 5.7 ) Sexual Dysfunction: Vilazodone may cause symptoms of sexual dysfunction ( 5.9 ) 5.1 Suicidal Thoughts and Behavior in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and over 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater in antidepressant-treated patients than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of