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 详细处方信息以本药内容附件PDF文件（2009113021360430）的“原文Priscribing Information”为准
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Saphris(asenapine)阿莫沙平舌下片

       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。

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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)

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 详细处方信息以本药内容附件PDF文件（2009113021360430.pdf）的“原文Priscribing Information”为准
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