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Usual Dosing (Adults)
CLINICAL PHARMACOLOGY Mechanism of Action: The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown. It has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.
INDICATIONS AND USAGE LATUDA is indicated for the treatment of patients with schizophrenia. The efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia.
The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
DOSAGE AND ADMINISTRATION Schizophrenia: The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg/day to 120 mg/day. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the maximum recommended dose is 80 mg/day.
Administration Instructions: LATUDA should be taken with food (at least 350 calories)
Dosage in Special Populations: Renal Impairment: It is recommended that LATUDA dose should not exceed 40 mg/day in patients with moderate and severe renal impairment (Clcr ≥ 10 mL/min to < 50 mL/min).
After administration of a single dose of 40 mg LATUDA to patients with mild, moderate and severe renal impairment, mean Cmax increased by 40%, 92% and 54%, respectively and mean AUC increased by 53%, 91% and 2- times, respectively compared to healthy matched subjects.
Dose adjustment is recommended in moderate and severe hepatic impairment patients. The dose in these patients should not exceed 40 mg/day.
Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inhibitors: When coadministration of LATUDA with a moderate CYP3A4 inhibitor such as diltiazem is considered, the dose should not exceed 40 mg/day. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole).
Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inducers: LATUDA should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin).
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.