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 hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1). • Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1). • Vilazodone hydrochloride tablets are not approved for use in pediatric patients (8.4).
Adult Dosing
General dosing
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 . • Prior to initiating vilazodone hydrochloride tablets, screen for bipolar disorder (2.2, 5.4). • When discontinuing vilazodone hydrochloride tablets, reduce the dosage gradually (2.4, 5.5). 2.1 Dosage for Treatment of Major Depressive Disorder The recommended target dosage for vilazodone hydrochloride tablet is 20 mg to 40 mg orally once daily with food . To achieve the target dosage, titrate vilazodone hydrochloride tablet 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.
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