CV: bradycardia, orthostatic hypotension, syncope, tachycardia.
Derm: pruritus, rash.
EENT: blurred vision.
Endo: hyperglycemia, hyperprolactinemia.
GI: nausea, esophageal dysmotility.
Hemat: AGRANULOCYTOSIS, anemia, leukopenia.
Metab: dyslipidemia, weight gain.
Neuro: akathisia, drowsiness, parkinsonism, agitation, anxiety, cognitive/motor impairment, dizziness, dystonia, NEUROLEPTIC MALIGNANT SYNDROME, SEIZURES, SUICIDAL THOUGHTS, tardive dyskinesia.
Schizophrenia
- PO (Adults): 40 mg once daily (not to exceed 160 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy:↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).
- PO (Children 13–17 yr): 40 mg once daily (not to exceed 80 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy:↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).
Renal Impairment
- PO (Adults and Children 13–17 yr): CCr <50 mL/min: 20 mg once daily (not to exceed 80 mg once daily).
Hepatic Impairment
- (Adults and Children 13–17 yr): Moderate hepatic impairment: 20 mg once daily (not to exceed 80 mg once daily); Severe hepatic impairment: 20 mg once daily (not to exceed 40 mg once daily).
Depressive Episodes Associated with Bipolar I Disorder
- PO (Adults): 20 mg once daily (not to exceed 120 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy:↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).
- PO (Children 10–17 yr): 20 mg once daily (not to exceed 80 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy:↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).
Renal Impairment
- PO (Adults and Children 10–17 yr): CCr <50 mL/min: 20 mg once daily (not to exceed 80 mg once daily).
Hepatic Impairment
- PO (Adults and Children 10–17 yr): Moderate hepatic impairment: 20 mg once daily (not to exceed 80 mg once daily); Severe hepatic impairment: 20 mg once daily (not to exceed 40 mg once daily).
Therapeutic Classification: antipsychotics
Pharmacologic Classification:
Absorption: 9–19% absorbed following oral administration.
Distribution: Unknown.
Protein Binding: >99%.
Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme. Two metabolites are pharmacologically active; 80% eliminated in feces, 8% in urine primarily as metabolites.
Half-life: 18 hr.