Lurasidone is indicated for:

• Schizophrenia
• Depressive episodes associated with Bipolar disorder

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 (D₂) and serotonin Type 2 (5-HT₂A) 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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Lurasidone should not be used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, etc.).

Lurasidone is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. It is also contraindicated for concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole) and a strong CYP3A4 inducer (e.g., rifampin).

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

Pregnancy Category B. Nursing mothers: Lurasidone is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Lurasidone, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

It can cause increased mortality in elderly patients with dementia-related psychosis and increase suicidal thoughts and behaviors in adolescents and young adults.

Atypical neuroleptic drugs

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