VILAZODONE HYDROCHLORIDE- vilazodone hydrochloride tablet, film coated
Teva Pharmaceuticals, Inc.
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)].
1 INDICATIONS AND USAGE
Vilazodone hydrochloride tablets are 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 tablets 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 Tablets
Prior to initiating treatment with vilazodone hydrochloride tablets 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 tablets. In addition, at least 14 days must elapse after stopping vilazodone hydrochloride tablets 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 tablets dose should not exceed 20 mg once daily. The original vilazodone hydrochloride tablet 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 tablets 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 tablets dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)].
2.5 Discontinuing Treatment with Vilazodone Hydrochloride Tablets
Adverse reactions may occur upon discontinuation of vilazodone hydrochloride tablets [see Warnings and Precautions (5.5)]. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Vilazodone hydrochloride tablets 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 tablets 20 mg once daily should be tapered to 10 mg once daily for 7 days.
3 DOSAGE FORMS AND STRENGTHS
Vilazodone hydrochloride tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets.
10 mg pink, oval shaped tablet, debossed with “TV” on one side and “V7” on the other side
20 mg beige, oval shaped tablet, debossed with “TV” on one side and “V71” on the other side
40 mg blue, oval shaped tablet debossed with “TV” on one side and “V72” on the other side
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)].
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 1,000 patients treated are provided in Table 1.
Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated
Increases Compared to Placebo
14 additional patients
18 to 24
5 additional patients
Decreases Compared to Placebo
25 to 64
1 fewer patient
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 hydrochloride, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
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