Administration Information

Administer PEXEVA as a single daily dose in the morning, with or without food.

Recommended Dosage

The recommended initial dosage and maximum dosage of PEXEVA in patients with MDD, OCD, PD, and GAD are presented in Table 1.

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

2.3 Screen for Bipolar Disorder Prior to Starting PEXEVA

Prior to initiating treatment with PEXEVA or other antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6)] .

2.4 Recommended Dosage Modifications for Elderly Patients, Patients with Severe Renal Impairment and Patients with Severe Hepatic Impairment

The recommended initial dose is 10 mg/day for elderly patients, patients with severe renal impairment and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day [see Use in Specific Populations ( 8.5, 8.6)]

Switching Patients 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 PEXEVA. In addition, at least 14 days must elapse after stopping PEXEVA before starting an MAOI antidepressant [see Contraindications ( 4), Warnings and Precautions ( 5.2)] .

Discontinuation of Treatment with PEXEVA

Adverse reactions may occur upon discontinuation of PEXEVA [see Warnings and Precaution ( 5.7)] . Gradually reduce the dosage rather than stopping PEXEVA abruptly whenever possible.