Lurasidone Hydrochloride

Luraprex is an atypical antipsychotic for the treatment of:

Schizophrenia

Depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as

adjunctive therapy with lithium or valproate.

The mechanism of action of Lurasidone in the treatment of schizophrenia and bipolar depression is unknown. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type-2 (5HT 2A ) receptor antagonism.

Lurasidone should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Lurasidone. Schizophrenia : The recommended starting dose of Lurasidone is 40 mg once daily. Initial dose titration is not required. The maximum recommended dose is 160 mg per day. Depressive Episodes Associated with Bipolar I Disorder : The recommended starting dose of Lurasidone is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. Moderate and Severe Renal Impairment : Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day . Moderate and Severe Hepatic Impairment : Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment Pediatric Use : Safety and effectiveness in pediatric patients have not been established.

The Luraprex dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., Diltiazem, Atazanavir, Erythromycin, Fluconazole, Verapamil, etc.). If Luraprex is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Luraprex dose. Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Luraprex, since these may inhibit CYP3A4 and alter Luraprex concentrations.

Hypersensitivity. Concurrent administration of strong CYP3A4 inhibitors (eg, Ketoconazole). Concurrent administration of strong CYP3A4 inducers (eg, Rifampin). Dementia-related psychosis.

Commonly observed adverse reactions are-somnolence, akathisia, extrapyramidal symptoms, and nausea etc.

Pregnancy Category B. Lurasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patient should be advised not to breast-feed an infant if they are taking Lurasidone.

Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). Neuroleptic malignant syndrome: Manage with immediate discontinuation and close monitoring. Tardive dyskinesia : Discontinue if clinically appropriate. Metabolic changes : Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. Hyperglycemia and diabetes mellitus : Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. Dyslipidemia : Undesirable alterations have been observed in patients treated with atypical antipsychotics. Weight Gain : Gain in body weight has been observed. Monitor weight. Hyperprolactinemia : Prolactin elevations may occur. Leukopenia, neutropenia and agranulocytosis : Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing Luraprex if a clinically significant decline in WBC occurs in the absence of other causative factors. Orthostatic hypotension and syncope : Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. In patients with known cardiovascularor cerebrovascular disease, and in antipsychotic-naïve patients, consider a lower starting dose and slower titration.

Store at temperature not exceeding 30°C in a dry place. Protect from light.