制造商：
Sunovion

药理分类：
非典型抗精神病药物（benzisothiazol衍生物）。

活性成分（补）：
Lurasidone 40毫克，80毫克;标签。

指示（补）：
精神分裂症。

药理作用：
对lurasidone的作用机理与其他药物的疗效有精神分裂症，是未知之数。有人建议说，精神分裂症患者的疗效lurasidone通过介导中枢多巴胺2型（D2）和类型2（5HT2A）受体拮抗剂羟色胺结合。

临床试验：
对lurasidone疗效成立于4短期（6周），安慰剂对照的成年人谁见了精神分裂症的DSM - IV标准的研究。一项研究包括了主动控制臂（奥氮平），以评估检测的灵敏度。阳性和阴性症状量表（PANSS），简明精神病评定量表派生（BPRSd），严重程度和临床总体印象量表（CGI - S）进行评估精神病症状和体征使用。与每台仪器相关的终点是从总成绩的第6周结束基线的变化。

在6周的安慰剂对照试验，涉及两个固定剂量的lurasidone（40或120mg/day），在终点都优于lurasidone剂量的BPRSd总成绩，并为CGI - S的安慰剂，正如lurasidone 80毫克/天另有6个星期的安慰剂对照试验。

在6周，安慰剂和积极控制的试验，涉及两个固定剂量的lurasidone（40或120mg/day）和主动控制（奥氮平），这两个lurasidone剂量，在终点主动控制均优于安慰剂组的PANSS总分评分，并为CGI - S的。

在6周的安慰剂对照试验，涉及三个lurasidone固定剂量（40，80或120mg/day），只有在终点80mg/day lurasidone剂量优于安慰剂的PANSS总分和CGI的学

因此，在40，80剂量的疗效lurasidone和120mg/day成立于双方各剂量研究。然而，120毫克剂量并没有出现在添加40毫克剂量的额外的好处。


法律分类：
接收

成人：
与食品采取（≥350卡路里）。 40毫克，每日一次。最大80mg/day。中度至重度肾或肝功能损害，伴随温和的CYP3A4抑制剂：最大40mg/day。

儿童：
不推荐。

禁忌（补）：
伴随强效CYP3A4抑制剂（如酮康唑）和诱导（如利福平）。


警告/注意事项：
老年人（老年痴呆症有关的精神病不是）;增加死亡风险。如果停止抗精神病药物恶性症候群（NMS）的发生;考虑停止，如果发生迟发性运动障碍。心或脑血管疾病。预现有的低白细胞或白血球低下/中性粒细胞的历史，在第一期治疗数月监控CBCs;停止，如果白细胞下降。中度至重度肝或肾功能损害。糖尿病的危险因素（获得基线空腹血糖）。监测血糖，血脂异常，体重增加，高泌乳素血症。癫痫发作史。暴露在高温下。吞咽困难。写实际金额最小的接收。妊娠（Cat.B）。哺乳的母亲。

互动（补）：
见成人和禁忌症。添加剂中枢神经系统的影响与酒精，其他中枢神经系统抑制剂。

不良反应（补）：
嗜睡，静坐不能，恶心，巴金森氏症，情绪激动，体位性低血压，昏厥，高血糖，血脂异常，体重增加，高泌乳素血症，白细胞减少/中性粒细胞减少，可能的网管系统，迟发性运动障碍。


如何提供：
制表- 28（4 × 7片吸塑卡），30，90，500

Latuda approved for schizophrenia

The FDA has approved Latuda (lurasidone HCl tablets, from Sunovion), an oral once-daily atypical antipsychotic, for the treatment of schizophrenia in adults. This approval was based on four six-week controlled studies which demonstrated that Latuda (lurasidone HCl tablets) has significantly greater improvement compared to placebo on the primary efficacy measures [the Positive and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale-derived from PANSS (BPRSd)] at study endpoint.

Latuda is expected to be available during the first quarter of 2011 in 40mg and 80mg dosage strengths.

Indication(s):

Schizophrenia.

Pharmacology:

The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown. It has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D₂) and serotonin Type 2 (5HT_2A) receptor antagonism.

Clinical Trials:

The efficacy of lurasidone was established in 4 short-term (6-week), placebo-controlled studies in adults who met DSM-IV criteria for schizophrenia. One study included an active-control arm (olanzapine) to assess assay sensitivity. The Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale derived (BPRSd), and Clinical Global Impression severity scale (CGI-S) were used for assessing psychiatric signs and symptoms. The endpoint associated with each instrument was change from baseline in the total score to the end of Week 6.

In a 6-week, placebo-controlled trial involving two fixed doses of lurasidone (40 or 120mg/day), both doses of lurasidone at endpoint were superior to placebo on the BPRSd total score, and the CGI-S, as was lurasidone 80mg/day in another 6-week placebo-controlled trial.

In a 6-week, placebo and active-controlled trial involving two fixed doses of lurasidone (40 or 120mg/day) and an active control (olanzapine), both lurasidone doses and the active control at endpoint were superior to placebo on the PANSS total score, and the CGI-S.

In a 6-week, placebo-controlled trial involving three fixed doses of lurasidone (40, 80 or 120mg/day), only the 80mg/day dose of lurasidone at endpoint was superior to placebo on the PANSS total score, and the CGI-S.

Thus, the efficacy of lurasidone at doses of 40, 80 and 120mg/day was established in two studies for each dose. However, the 120mg dose did not appear to add additional benefit over the 40mg dose.

Legal Classification:

Rx

Adults:

Take with food (≥350 calories). 40mg once daily. Max 80mg/day. Moderate to severe renal or hepatic impairment, concomitant moderate CYP3A4 inhibitors: max 40mg/day.

Children:

Not recommended.

Contraindication(s):

Concomitant strong CYP3A4 inhibitors (eg, ketoconazole) and inducers (eg, rifampin).

Warnings/Precautions:

Elderly (not for dementia-related psychosis); increased risk of death. Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1^st few months of therapy; discontinue if WBCs decline. Moderate to severe hepatic or renal impairment. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia. History of seizures. Exposure to extreme heat. Dysphagia. Write Rx for smallest practical amount. Pregnancy (Cat.B). Nursing mothers.

Interaction(s):

See Adults and Contraindications. Additive CNS effects with alcohol, other CNS depressants.

Adverse Reaction(s):

Somnolence, akathisia, nausea, parkinsonism, agitation; orthostatic hypotension, syncope, hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia, leukopenia/neutropenia, possible NMS, tardive dyskinesia.

How Supplied:

Tabs—28 (4 blister cards x 7 tabs), 30, 90, 500

Last Updated:

2/18/2011