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  药店国别: 德国药房
产地国家: 德国
所属类别: 心血管系统药物->治疗心衰药物
处方药:处方药
包装规格: 15毫克/片 10片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
大冢制药
生产厂家英文名:
Otsuka Pharma GmbH
该药品相关信息网址1:
http://www.samsca.com/
原产地英文商品名:
SAMSCA 15mg/tab 10tabs/box
原产地英文药品名:
tolvaptan
中文参考商品译名:
SAMSCA 15毫克/片 10片/盒
中文参考药品译名:
托伐普坦
原产地国家批准上市年份:
2009/05/19
英文适应病症1:
significant hypervolemic and euvolemic hyponatremia
英文适应病症2:
heart failure
英文适应病症3:
cirrhosis
英文适应病症4:
Syndrome of Inappropriate Antidiuretic Hormone (SIADH)
临床试验期:
完成
中文适应病症参考翻译1:
高容量性/等容量性低钠血症
中文适应病症参考翻译2:
心衰
中文适应病症参考翻译3:
硬化症
中文适应病症参考翻译4:
抗利尿激素分泌异常综合征
药品信息:

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 详细处方信息以本药内容附件PDF文件(200992400045522.pdf)的“原文Priscribing Information”为准
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INDICATIONS AND USAGE
SAMSCA is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant  hypervolemic and euvolemic hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

Important Limitations:
• Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological

symptoms should not be treated with SAMSCA.
• It has not been established that SAMSCA provides a symptomatic benefit to patients.

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DOSAGE AND ADMINISTRATION
• SAMSCA should be initiated and re-initiated in a hospital.
• The recommended starting dose is 15 mg once daily. Dosage may be increased at intervals ≥24 hr to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium. Monitor serum sodium and volume status.

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DOSAGE FORMS AND STRENGTHS
• Tablets: 15 mg and 30 mg

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CONTRAINDICATIONS
• Do not administer to patients requiring urgent intervention to raise serum sodium acutely.
• Do not use in patients who are unable to sense or to respond appropriately to thirst.
• Do not use in patients with hypovolemic hyponatremia.
• Do not use with strong CYP 3A inhibitors.
• Do not administer to patients who are anuric as no benefit is expected.

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WARNINGS/PRECAUTIONS
• Monitor serum sodium and neurologic status as serious neurologic sequelae can result from
over rapid correction of sodium.
• Because of the potential increased risk of gastrointestinal bleeding in patients with cirrhosis,
use in patients with cirrhosis only when the need to treat outweighs this risk.
• Dehydration and hypovolemia may require intervention.
• Avoid use with hypertonic saline.
• Avoid use with CYP 3A inducers and moderate CYP 3A inhibitors.
• Consider dose reduction if co-administered with P-gp inhibitors.
• Monitor serum potassium in patients with potassium > 5 mEq/L or on drugs known to increase potassium.

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ADVERSE REACTIONS
Most common adverse reactions (≥ 5% placebo) are thirst, dry mouth, asthenia, constipation,
pollakiuria or polyuria, and hyperglycemia.


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FDA批准托伐普坦片(Samsca)治疗低钠血症

 
    FDA 已经批准托伐普坦片(tolvaptan,Samsca)治疗低钠血症,本品是唯一获准治疗该症的口服型选择性加压素拮抗剂。

Samsca在美国地区的销售由Otsuka美国分公司负责。
  FDA 新药审评中心心血管与肾病产品的主任Norman Stockbridge 医学博士对外发表声明时称:随着Samsca的获准,医生对治疗低钠血症又多了一种新的选择,本品被用来治疗由充血性心衰、肝硬化以及抗利尿激素分泌不足综合征导致的低钠血症。

当血浆中钠离子浓度降低时,为了保持细胞内外的钠离子浓度平衡,细胞外的液体就会进入细胞内,这样细胞就会肿胀。当脑细胞肿胀时,就会导致各种低钠血的症状出现。包括头昏、虚弱、头痛、恶心、意识错乱以及意识减缩和惊厥发生。严重的低钠血症会导致昏迷和死亡,目前Samsca在重度低血钠患者中还无相应的研究。
  Samsca 可以升高血浆中钠离子浓度,帮助多余的水分从尿液排出。在临床研究中,本品与安慰剂相比,明显升高了患者血浆中的钠离子浓度。

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 详细处方信息以本药内容附件PDF文件(200992400045522.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-08-04
附件:
 
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