HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA.
LATUDA (LURASIDONE HCL) tablets for oral administration,
Initial U.S. Approval: 2010
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis. (5.1)
INDICATIONS AND USAGE
LATUDA is an atypical antipsychotic agent indicated for the treatment of patients with schizophrenia (1). Efficacy was established in four 6-week controlled studies of adult patients with schizophrenia (14.1).
DOSAGE AND ADMINISTRATION
The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. The maximum recommended dose is 80 mg once daily. LATUDA should be taken with food (2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg and 80 mg (3)
CONTRAINDICATIONS
Any known hypersensitivity to LATUDA or any components in the formulation (4).
Coadministration with a strong CYP3A4 inhibitor (e.g., ketoconazole) and inducer (e.g.,rifampin) (4).
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs. (5.2).
Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.3).
Tardive Dyskinesia: Discontinue if clinically appropriate (5.4).
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascu |
