Lurasidone Hydrochloride

What it is and how it works

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

Indications

Lurasidone hydrochloride tablets are indicated for: • Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia . • Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) . • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) . Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) • Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1 , 14.2 ) • Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate ( 1 , 14.2 )

Dosage and administration (summary)

Lurasidone hydrochloride tablets should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of lurasidone hydrochloride tablets ( 2.3 , 12.3 ). Indication Starting Dose Recommended Dose Schizophrenia – adults 40 mg per day 40 mg to 160 mg per day Schizophrenia – adolescents (13 to 17 years) 40 mg per day 40 mg to 80 mg per day Bipolar Depression - adults 20 mg per day 20 mg to 120 mg per day Bipolar Depression – pediatric patients (10 to 17 years) 20 mg per day 20 mg to 80 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 ( 2.4 , 8.6 ).

Contraindications

• Known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone . • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) . • Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.) . • Known hypersensitivity to lurasidone hydrochloride tablets or any components in the formulation .

Warnings and precautions

• 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: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain . • Hyperprolactinemia: Prolactin elevations may occur .

Pregnancy

Pregnancy Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery . There are no studies of lurasidone hydrochloride use in pregnant women.

Storage and supply

Lurasidone Hydrochloride Tablets 20 mg: White to off white, round, biconvex tablets, debossed with "L" on one side and "1" on the other side. NDC: 70518-4563-00 PACKAGING: 30 in 1 BLISTER PACK Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) . Repackaged and Distributed By: Remedy Repack, Inc.

Source: Lurasidone Hydrochloride (Lurasidone Hydrochloride) — US FDA prescribing information, 2026-02-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.