Vilazodone

Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults (1).

• Recommended target dosage: 20 mg to 40 mg once daily with food . • 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 . • When discontinuing vilazodone hydrochloride tablets, reduce the dosage gradually
• 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 [see Clinical Pharmacology , Clinical Studies ]
• 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
• Screen for Bipolar Disorder Prior to Starting Vilazodone Hydrochloride Tablets Prior to initiating treatment with vilazodone hydrochloride tablet or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ]. …

Vilazodone hydrochloride tablets are available as 10 mg, 20 mg and 40 mg, film-coated tablets. 10 mg : Pink, oval, film-coated, biconvex tablets debossed with ‘497’ on one side and plain on other side. 20 mg : Orange, oval, film-coated, biconvex tablets debossed with ‘498’ on one side and ’L’ on other side. …

• The safety and effectiveness of vilazodone hydrochloride tablets have not been established
• In pediatric patients
• For the treatment of MDD
• Antidepressants increased the risk of suicidal thoughts and behaviors
• In pediatric patients [see Boxed Warning, Warnings and Precautions , and Adverse Reactions ]
• Juvenile Animal Toxicity Data In a juvenile animal study, male and female rats were treated with vilazadone (10, 50, and 200 mg/kg/day) starting on postnatal day (PND) 21 through 90. …

Based on a pharmacokinetic study, no dosage adjustment of vilazodone hydrochloride tablets are recommended on the basis of age (see Figure 3). Results from pharmacokinetic study of a single 20 mg vilazodone hydrochloride tablet dose in geriatric subjects (> 65 years-old) vs. younger subjects (24 to 55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups [see Clinical Pharmacology (12.3)]. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ]
• Dosage and Administration Instruct patients to take vilazodone hydrochloride tablets with food and to follow prescribed dosage instructions [see Dosage and Administration ]. …

Vilazodone hydrochloride tablets are 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 [see Warnings and Precautions (5.2), Drug Interactions (7)]. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4).

•CYP3A4 Inhibitors: The vilazodone hydrochloride tablet dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors (2.4, 7). •CYP3A4 Inducers: Consider increasing vilazodone hydrochloride tablets 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 (2.4, 7). …

• 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 hydrochloride tablets 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). …

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)]. • Serotonin Syndrome [see Warnings and Precautions (5.2)]. • Increased Risk of Bleeding [see Warnings and Precautions (5.3)]. • Activation of Mania or Hypomania [see Warnings and Precautions (5.4)]. • Discontinuation Syndrome [see Warnings and Precautions (5.5)]. • Seizures [see Warnings and Precautions (5.6)]. • Angle-Closure Glaucoma [see Warnings and Precautions (5.7)]. • Hyponatremia [see Warnings and Precautions (5.8)]. • Sexual Dysfunction [see Warnings and Precautions (5.9)]. …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. …

There is limited clinical trial experience regarding human overdose with vilazodone hydrochloride tablets. The adverse reactions associated with overdose of vilazodone hydrochloride tablets at doses of 200 to 280 mg (5 to 7 times the recommended dosage) as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation. For current information on the management of poisoning or overdose, contact a poison control center at 1-800-222-1222. No specific antidotes for vilazodone are known. …

9.1 Controlled Substance Vilazodone hydrochloride tablets are not a controlled substance. 9.2 Abuse and Dependence Vilazodone hydrochloride tablets have been systematically studied in animals and did not demonstrate abuse or dependence potential. While vilazodone hydrochloride tablets have not been systematically studied in humans for its potential for abuse, there was no suggested evidence of drug-seeking behavior in the clinical studies.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.