Granada Dosage/Direction for Use

Adults: The recommended starting dose is 40 mg once daily. Initial dose titration is not required. Lurasidone is effective in a dose range of 40 to 160 mg once daily. Lurasidone should be taken with food (at least 350 calories).
Patients who have been receiving lurasidone for the treatment of schizophrenia may continue maintenance therapy at the same dose.
Adolescents: The recommended starting dose of lurasidone is 40 mg/day. Lurasidone was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 40 mg and 80 mg. Lurasidone should be taken with food.
Renal Impairment: After administration of a single dose of 40 mg to patients with mild, moderate and severe renal impairment, mean C_max increased by 40%, 92%, and 54%, respectively and mean AUC_(0-∞) increased by 53%, 91% and 2-times, respectively compared to healthy matched subjects.
Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients. The dose in these patients should not exceed 80 mg/day.
Hepatic Impairment: In a single-dose study of 20 mg, lurasidone mean AUC_(0-last) was 1.5-times higher in subjects with mild hepatic impairment (Child-Pugh Class A), 1.7-times higher in subjects with moderate hepatic impairment (Child-Pugh Class B) and 3-times higher in subjects with severe hepatic impairment (Child-Pugh Class C) compared to the values for healthy matched subjects. Mean C_max was 1.3, 1.2, and 1.3-times higher for mild, moderate and severe hepatic impaired patients, respectively, compared to the values for healthy matched subjects.
Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score 10 to 15) patients. The dose in moderate hepatic impaired patients should not exceed 80 mg/day and the dose in severe hepatic impaired patients should not exceed 40 mg/day.
Concomitant use with CYP3A4 inhibitors: Lurasidone is contraindicated in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).
If lurasidone is being prescribed and a moderate CYP3A4 inhibitor (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil) is added to the therapy, the lurasidone dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and lurasidone is added to therapy, the maximum recommended dose of lurasidone is 80 mg/day.
Grapefruit and grapefruit juice should be avoided in patients taking lurasidone, since these may inhibit CYP3A4 and alter lurasidone concentrations.
Concomitant use with CYP3A4 inducers: Lurasidone is contraindicated in combination with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If lurasidone is used in combination with a moderate CYP3A4 inducer, it may be necessary to increase the lurasidone dose after chronic treatment (7 days or more) with the CYP3A4 inducer.
Switching between antipsychotic medicinal products: Data were collected in an open-label study to evaluate switching stable but symptomatic patients with schizophrenia from other antipsychotics to lurasidone. The recommended starting dose of lurasidone is 40 mg/day. Initial dose titration is not required.
Pediatric Population: The safety and effectiveness of lurasidone in pediatric patients aged less than 13 years have not been established.
Elderly Population: No dose adjustment is necessary in elderly patients. Clinical studies of lurasidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. In elderly patients with psychosis (65 to 85), lurasidone concentrations (20 mg/day) were similar to those in young subjects.