Generic Name and Formulations:
Lurasidone HCl 20mg, 40mg, 60mg, 80mg, 120mg; tabs.

Company:
Sunovion
Indications for LATUDA:
Major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate.

Adult:
Take with food (≥350 calories). Initially 20mg once daily. Usual range: 20–120mg/day. Max 120mg/day. Moderate (CrCl 30 to <50mL/min) to severe renal impairment (CrCl <30mL/min), moderate hepatic impairment (Child Pugh Score 7–9): initially 20mg; max 80mg/day. Severe hepatic impairment (Child Pugh Score 10–15): initially 20mg; max 40mg/day. If moderate CYP3A4 inhibitors (eg, diltiazem, atazanavir, erythromycin, fluconazole, verapamil) is added concomitant to prescribed lurasidone therapy: reduce lurasidone dose to ½ of the original dose; if lurasidone is added concomitant to prescribed moderate CYP3A4 therapy: initially 20mg/day; max 80mg/day. Concomitant moderate CYP3A4 inducers: may need to increase lurasidone dose after chronic treatment (≥7 days) with inducer.

Children:
Not established.

Contraindications:
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) and inducers (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine).

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease, risk of hypotension: monitor orthostatic vital signs. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Moderate to severe hepatic or renal impairment. History of seizures. Mania or hypomania (monitor). Dysphagia. Parkinson's disease. Dementia with Lewy Bodies. Exposure to extreme heat. Write ℞ for smallest practical amount; closely supervise high-risk patients (suicidal ideation). Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:
See Adults and Contraindications. Avoid grapefruit and grapefruit juice.

Pharmacological Class:
Atypical antipsychotic (benzoisothiazol derivative).

Adverse Reactions:
Somnolence, akathisia, extrapyramidal symptoms, nausea, parkinsonism, agitation; orthostatic hypotension and syncope possible.

How Supplied:
Tabs—30, 90, 500, 100 (10 blister cards x 10 tabs)
美国食品和药品监督管理局2010年10月28日批准Latuda(lurasidone HCl)片为治疗精神分裂症成年。
精神分裂症在给定年累及美国约约百分之一人口，年龄18岁和以上。最突出症状包括幻觉，妄念，思维和行为紊乱，和多疑。听到其他人听不到的声音是最常见类型的幻觉。这些经验可能使人们对这个疾病恐惧和孤独。
FDA的药物评价和研究中心中精神病产品室主任Thomas Laughren, M.D.医学博士说“精神分裂症可能是一种需要终身治疗的毁灭性疾病，”“有些患者对某些类型药物治疗没有反应，所以可得到多种治疗选择很重要。”
Latuda属于非典型抗精神病药物类。所有非典型抗精神病药物含一个黑框警告警示开处方者伴随说明书外使用这些药物治疗行为问题与痴呆相关的精神病的老年人增加死亡风险。这类中没有药物被批准治疗痴呆相关的精神病患者。
精神分裂症成年的四项6周对照研究证实Latuda的有效性和安全性。