LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R ,4 S ,7 R ,7a S )-2-{(1 R ,2 R )-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H -isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S•HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practi...

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LATUDA is 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) . LATUDA is an atypical antipsychotic indicated for the treatment of: Schizophrenia ...

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LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA ( 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 an...

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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 LATUDA or any components in the formulation. Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole) ( 2.6 , 4 , 7.1 ). Concomitant u...

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10.1 Human Experience In premarketing clinical studies, accidental or intentional overdosage of LATUDA was identified in one patient who ingested an estimated 560 mg of LATUDA. This patient recovered without sequelae. This patient resumed LATUDA treatment for an additional two months. 10.2 Management of Overdosage No specific antidotes for LATUDA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple dru...

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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. Leukopenia, Neutropenia,...

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7.1 Drugs Having Clinically Important Interactions with LATUDA Table 34: Clinically Important Drug Interactions with LATUDA Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [ see Clinical Pharmacology ]. Intervention: LATUDA should not be used concomitantly with strong CYP3A4 inhibitors [ see Contraindications ]. Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, ...

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8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LATUDA during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal sy...

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