Generic name: vilazodone hydrochloride
Dosage form: tablet
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Initial Treatment of Major Depressive Disorder
The recommended dose for VIIBRYD is 40 mg once daily. VIIBRYD should be titrated, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily. VIIBRYD should be taken with food. VIIBRYD blood concentrations (AUC) in the fasted state can be decreased by approximately 50% compared to the fed state, and may result in diminished effectiveness in some patients [see Clinical Pharmacology (12.3)].
The efficacy of VIIBRYD has not been systematically studied beyond 8 weeks. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.
2.3 Concomitant Use of CYP3A4 Inhibitors or CYP3A4 Inducers
Patients receiving concomitant CYP3A4 inhibitors:
Reduce the VIIBRYD dose to 20 mg if co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole). During co-administration with moderate inhibitors of CYP3A4 (e.g., erythromycin), the VIIBRYD dose should be reduced to 20 mg for patients with intolerable adverse events. The VIIBRYD dose should be readjusted to the original level when CYP3A4 inhibitors are discontinued [see Drug Interactions (7.5)].
Patients receiving concomitant CYP3A4 inducers:
Based on clinical response, consider increasing the dose of VIIBRYD up to 2-fold when concomitantly used with strong CYP3A4 inducers (e.g., carbamazepine) for greater than 14 days. The maximum daily dose should not exceed 80 mg. If CYP3A4 inducers are discontinued, reduce the VIIBRYD dose to the original level in 14 days [see Drug Interactions (7.5)].
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate [see Warnings and Precautions (5.6)].
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with VIIBRYD. Conversely, at least 14 days should be allowed after stopping VIIBRYD before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
Use of VIIBRYD with Other MAOIs such as Linezolid or Methylene Blue
Do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving VIIBRYD therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, VIIBRYD should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with VIIBRYD may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with VIIBRYD is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].