美国食品药品监督管理局（FDA）批准先灵葆雅公司的Saphris（阿莫沙平）舌下片上市。阿莫沙平是一种非典型抗精神病药物，用于治疗成人精神分裂症、慢性重度脑功能障碍和I型双相性精神障碍。
FDA基于3项短期、安慰剂对照和阳性药物对照的临床试验证明Saphris治疗精神分裂症的有效性；基于2项短期、安慰剂和阳性药物对照的临床试验证明Saphris治疗双相性精神障碍的有效性。
作为精神疾病治疗药物，该药的说明书中有[黑框警示]信息，警示医生， 老年痴呆症患者用药存在治疗风险。Saphris的治疗精神分裂症的临床试验常见不良反应为燥动、口腔鼓味觉减退和嗜睡。治疗双相性精神障碍的临床试验常见不良反应为燥动、体重增加、嗜睡、眩晕和运动失调。

通用名称为SAPHRIS
阿塞那平5毫克，10毫克，舌下（SL）选项卡。

法律分类：
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类药物为SAPHRIS
非典型抗精神病药物（oxepino二苯并吡咯）。

制造商的SAPHRIS
默克制药公司
主治为SAPHRIS
精神分裂症。

成人剂量为SAPHRIS
不要压碎，咀嚼，或吞咽;不要吃或喝给药后10分钟。允许片剂完全溶解舌。急性期治疗：5毫克，每日两次。维护：5毫克每天两次为1个星期，再增加至10毫克，每天两次。最大剂量：10毫克，每天两次。重新评估定期。

儿童剂量为SAPHRIS
不推荐。

为SAPHRIS警告/注意事项
避免在先天性长QT综合征，心律失常。严重肝功能损害：不推荐。停止抗精神病药恶性综合征发生;考虑中止如果出现迟发性运动障碍。心脑血管疾病。前现有的低白细胞减少/中性粒细胞的白细胞或历史;第一几个月的治疗期间的监测CBCS;停止，如果白细胞下降。糖尿病的危险因素（获得基线空腹血糖）。显示器为高血糖。癫痫发作的历史。暴露在高温。吞咽困难。写为最小的实际金额℞。长者（不适用于老年痴呆症相关的精神病）。新生儿：锥体外系和/或戒断症状交付后的风险（因暴露在第三早孕）。怀孕（Cat.C）。哺乳的母亲：不推荐。

为SAPHRIS的相互作用
避免药物可以延长QT间隔（例如，1A类或III类抗心律失常药物，齐拉西酮，氯丙嗪，甲硫达嗪，莫西沙星，酒精）。 Potentiates抗高血压药物。 Potentiated由氟伏沙明。与其他中枢神经系统药物，是CYP2D6的底物/抑制剂的药物，引起体位性低血压的药物，和抗胆碱能活性药物的注意事项。

SAPHRIS的不良反应
锥体外系的影响，静坐不能，口腔感觉减退，嗜睡，头晕，胃肠不适，体位性低血压，晕厥，QT间期延长，高血糖，体重增加，过敏反应，高泌乳素血症。

SAPHRIS是如何提供的？
SL标签60
SL标签（黑樱桃味）-60

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SAPHRIS® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

WARNINGS AND PRECAUTIONS

• Cerebrovascular Adverse Events: 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)
• Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with, and at risk for, diabetes. (5.5)
• Orthostatic Hypotension and Syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. Use with caution in patients with known cardiovascular or cerebrovascular disease, and in antipsychotic-naïve patients. (5.7)
• Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and SAPHRIS should be discontinued at the first sign of a decline in WBC in the absence of other causative factors. (5.8)
• QT Prolongation: Increases in QT interval; avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. (5.9)
• Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. (5.11)
• Potential for Cognitive and Motor Impairment: Use caution when operating machinery. (5.12)
• Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients. (5.14)

USE IN SPECIFIC POPULATIONS

• Pregnancy: Use SAPHRIS during pregnancy only if the potential benefit justifies the potential risk. (8.1)
• Nursing Mothers: Breast feeding is not recommended. (8.3)
• Pediatric Use: Safety and effectiveness have not been established. (8.4)
• Renal Impairment: No dose adjustment needed. (8.6)
• Hepatic Impairment: SAPHRIS is not recommended in patients with severe hepatic impairment (Child-Pugh C). (2.4, 8.7, 12.3)

IMPORTANT:

• Do not remove tablet until ready to administer.
• Use dry hands when handling tablet.

Step 1. Firmly press and hold thumb button, then pull out tablet pack.

Do not push tablet through tablet pack.

Do not cut or tear tablet pack.

Step 2. Peel back colored tab.

Step 3. Gently remove tablet.

Do not crush tablet.

Step 4. Place tablet under tongue and allow it to dissolve completely.

Do not chew or swallow tablet.

Do not eat or drink for 10 minutes.

Step 5. Slide tablet pack into case until it clicks

Last updated on RxList: 8/31/2009