Latuda

Lurasidone HCl

Major depressive episode associated w/ bipolar I disorder (bipolar depression) in adults & adolescents 13-17 yr as monotherapy; in adults as adjunctive treatment w/ lithium or valproate. Schizophrenia in adults & adolescents 13-17 yr.

Depressive episodes associated w/ bipolar I disorder Adult Initially 20 mg once daily. Effective dose range: 20-120 mg daily. Max: 120 mg daily. Adolescent 13-17 yr Initially 20 mg once daily, may be increased after 1 wk. Effective dose range: 20-80 mg daily. Max: 80 mg daily. Schizophrenia Adult Initially 40 mg once daily. Effective dose range: 40-160 mg daily. Max: 160 mg daily. Adolescent 13-17 yr Initially 40 mg once daily. Effective dose range: 40-80 mg daily. Max: 80 mg daily. Moderate (CrCl 30 to <50 mL/min) & severe (CrCl <30 mL/min) renal impairment; moderate hepatic impairment (Child-Pugh 7-9); concomitant use w/ moderate CYP3A4 inhibitors Initially 20 mg daily. Max: Not to exceed 80 mg daily. Severe hepatic impairment (Child-Pugh 10-15) Initially 20 mg daily. Max: Not to exceed 40 mg daily.

Should be taken with food: Should be taken w/ food (at least 350 cal).

Hypersensitivity. Concomitant use w/ strong CYP3A4 inhibitors & inducers.

Discontinue use if NMS is suspected. Not approved for treatment of patients w/ dementia-related psychosis. Monitor patients for the emergence for mania or hypomania. Increased risk of orthostatic hypotension & syncope in patients w/ dehydration, hypovolemia, history of CV disease (eg, heart failure, MI, ischemia or conduction abnormalities), history of cerebrovascular disease, antipsychotic-naive patients, treatment w/ antihypertensives. History of seizures or conditions lowering seizure threshold eg, Alzheimer's dementia; history of or at risk for sleep apnoea. Patients at risk for aspiration pneumonia. Increased sensitivity in patients w/ Parkinson's disease or dementia w/ Lewy bodies. Elevation in core body temp eg, exercising strenuously, exposure to extreme heat, concomitant medication w/ anticholinergic activity. Tardive dyskinesia; hyperglycemia, DM, dyslipidemia, wt gain; hyperprolactinemia; somnolence, postural hypotension, motor & sensory instability leading to falls; potential for cognitive & motor impairment. Monitor for clinical worsening & emergence of suicidal thoughts or behaviors. Regularly monitor patients w/ DM for worsening of glucose control; patients w/ risk factors for DM should undergo fasting blood glucose testing at the beginning & periodically during treatment. Frequently monitor CBC in patients w/ preexisting low WBC or history of drug-induced leukopenia/neutropenia. Monitor patients w/ neutropenia for fever or other symptoms of infection. Carefully evaluate for history of drug abuse & observe for signs of misuse or abuse eg, development of tolerance, drug-seeking behavior, dose increases. Long-term use (>6 wk). Avoid use w/ grapefruit & grapefruit juice. Concomitant use w/ moderate CYP3A4 inhibitors & inducers. May affect ability to drive & use machines. Moderate to severe renal & hepatic impairment. Pregnancy & lactation. Ped <13 yr. Not for irritability associated w/ autistic disorder in ped patients. Monitor neonates for extrapyramidal or w/drawal symptoms if exposed during 3rd trimester of pregnancy. Elderly ≥65 yr.

Bipolar depression: Adults: Monotherapy: Akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, anxiety. Adjunctive therapy: Akathisia, somnolence. Ped 10-17 yr: Nausea, increased wt, insomnia. Schizophrenia: Adults: Somnolence, akathisia, extrapyramidal symptoms, nausea. Adolescents 13-17 yr: Somnolence, nausea, akathisia, extrapyramidal symptoms (non-akathisia, 40 mg), vomiting, rhinorrhea/rhinitis (80 mg).

Increased exposure w/ strong (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) & moderate (eg, diltiazem, atazanavir, erythromycin, fluconazole, verapamil) CYP3A4 inhibitors. Decreased exposure w/ strong (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine) & moderate (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin) CYP3A4 inducers.

Antipsychotics

N05AE05 - lurasidone ; Belongs to the class of indole derivatives antipsychotics.

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