Vilazodone

VILAZODONE- vilazodone hydrochloride tablet
VILAZODONE- vilazodone hydrochloride tablet
Apotex Corp

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 is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .

1 INDICATIONS AND USAGE

Vilazodone 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 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.

3 DOSAGE FORMS AND STRENGTHS

Vilazodone tablets are available as 10 mg, 20 mg and 40 mg film-coated tablets.

10 mg pink, oval tablet, debossed with 10 on one side
20 mg orange, oval tablet, debossed with 20 on one side40 mg blue, oval tablet, debossed with 40 on one side

4 CONTRAINDICATIONS

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 [see Warnings and Precautions ( 5.2) , Drug Interactions ( 7) ].

5 WARNINGS AND PRECAUTIONS

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 suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.

Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
Age Range (years) Drug-Placebo Difference in Number of Patient s with Suicidal Thoughts or Behaviors per 1000 Patients Treated
Increases Compared to Placebo
<18 14 additional patients
18-24 5 additional patients
Decreases Compared to Placebo
25-64 1 fewer patient
≥65 6 fewer patients

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing vilazodone, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

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