Luradox 20

Psychotic Disorder, Schizophrenia, bipolar depression.

Should be taken with food

Schizophrenia 40 mg PO once daily initially; may increase to 80 mg/day if needed; not to exceed 160 mg/day Bipolar Depression Indicated for major depressive episodes associated with bipolar I disorder; may be used as either monotherapy or adjunctive therapy with lithium or valproate 20 mg PO once daily initially; may increase dose if needed, not to exceed 120 mg/day Hepatic impairment Mild (Child-Pugh class A): Dosage adjustment may not be necessary; use caution Moderate (Child-Pugh class B): 20 mg/day initially; not to exceed 80 mg/day Severe (Child-Pugh class C): 20 mg/day initially; not to exceed 40 mg/day

Safety and efficacy not established

Renal impairment CrCl 50 mL/min or greater: Dosage adjustment not required CrCl <50 mL/min: 20 mg/day initially; not to exceed 80 mg/day

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

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 (5HT2A) receptor antagonism.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants 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 Lurasidone 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. Lactation: Unknown whether drug is distributed in breast milk; use caution

>10% Somnolence, dose related (22%),Akathisia, dose related (15%),Fasting glucose increased (10-14%),Nausea (12%),Parkinsonism (11%) 1-10% Vomiting (8%),Dyspepsia (8%),Anxiety (8%),Agitation (6%),Anxiety (6%),Dystonia (5%),Dizziness (5%),Fatigue (4%),Back pain (4%),Restlessness (3%),Salivary hypersecretion (2%)