For oral use once daily with or without food.
Dosage and Method of Administration: Adjunctive Treatment of Major Depressive Disorder: The recommended starting dose for REXULTI as adjunctive treatment is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient's clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials. The benefit of the 3 mg dose has not been clearly established. Periodically reassess to determine the continued need and appropriate dose for treatment.
The long-term efficacy of REXULTI as adjunctive treatment in MDD has not been established.
Schizophrenia: The recommended starting dose for REXULTI in the treatment of patients with schizophrenia is 1 mg once daily on days 1 to 4. The recommended target dose range is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 4 mg.
Maintenance treatment: The recommended maintenance dose range is 2 mg/day to 4 mg/day. Periodically reassess to determine the continued need for maintenance treatment.
Dosing Precautions: Dosing Adjustment for Hepatic Impairment: For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the maximum recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients with schizophrenia.
Dosing Adjustment for Renal Impairment: For patients with moderate, severe or end-stage renal impairment (creatinine clearance CLcr<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia. (See Table 4.)
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