RALDESY TMis indicated for the treatment of major depressive disorder (MDD) in adults.
The initial dosage of RALDESY for the treatment of MDD in adults is 150 mg daily, taken orally, in divided doses. The dosage should be initiated at a low-dose and increased gradually, depending on clinical response and an tolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg daily every 3 to 4 days. The maximum recommended dosage for outpatients usually should not exceed 400 mg daily in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to, but not in excess, of 600 mg daily in divided doses.
Administer RALDESY orally after a meal or light snack.
Prior to initiating treatment with RALDESY or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of RALDESY. In addition, at least 14 days must elapse after stopping RALDESY before starting an MAOI antidepressant.
Coadministration with Strong CYP3A4 Inhibitors
Consider reducing RALDESY dose based on tolerability when RALDESY is coadministered with a strong CYP3A4 inhibitor.
Coadministration with Strong CYP3A4 Inducers
Consider increasing RALDESY dose based on therapeutic response when RALDESY is coadministered with a strong CYP3A4 inducer.
Adverse reactions may occur upon discontinuation of RALDESY. Gradually reduce the dosage rather than stopping RALDESY abruptly whenever possible.
RALDESY 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.
Full Prescribing Information: DailyMed
