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  药店国别: 美国药房
产地国家: 美国
所属类别: 调节水、电解质药->治疗低钠血症
处方药:处方药
包装规格: 20毫克/100毫升/袋 10袋/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
ASTELLAS
生产厂家英文名:
ASTELLAS
该药品相关信息网址1:
http://www.vaprisol.com/
该药品相关信息网址2:
http://www.rxlist.com/vaprisol-drug.htm
该药品相关信息网址3:
http://www.chinapharm.com.cn/html/xcp/1147317323078.html
原产地英文商品名:
VAPRISOL 20MG/100ML/BAG 10BAGS/BOX
原产地英文药品名:
CONIVAPTAN HCL/DEXTROSE 5%-WATER
原产地英文化合物名称:
N-[4-[(4,5-dihydro-2-methylimidazo[4,5-d][1]benzazepin-6(1H)-yl)carbonyl]phenyl]- [1,1'-Biphenyl]-2-carboxamide hydrochloride
中文参考商品译名:
VAPRISOL 20毫克/100毫升/袋 10袋/盒
中文参考药品译名:
盐酸考尼伐坦/葡萄糖5%-水
原产地国家批准上市年份:
2005/12/29
英文适应病症1:
Euvolemic and Hypervolemic hyponatremia in hospitalized patients
临床试验期:
完成
中文适应病症参考翻译1:
住院患者的无水肿性及水肿性低钠血症
药品信息:

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详细处方信息以本药内容附件PDF文件(20101509404630.pdf)的“原文Priscribing Information”为准
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                            部分中文 VAPRISOL 处方信息(仅供参考)

VAPRISOL® (conivaptan hydrochloride injection) is a nonpeptide, dual antagonist of arginine vasopressin (AVP) V1A and V2 receptors.
Conivaptan hydrochloride is chemically [1,1'-biphenyl]-2-carboxamide, N-[4-[(4,5-dihydro-2-methylimidazo[4,5-d]
[1]benzazepin-6(1H)-yl)carbonyl]phenyl]-, monohydrochloride, having a molecular weight of 535.04 and molecular formula C32H26N4O2·HCl.

INDICATIONS
VAPRISOL is indicated for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients.
Important Limitation
VAPRISOL is not indicated for the treatment of congestive heart failure. VAPRISOL should only be used for the
treatment of hyponatremia in patients with underlying heart failure when the expected clinical benefit of raising serum sodium outweighs the increased risk of adverse events for heart failure patients.

DOSAGE AND ADMINISTRATION
VAPRISOL is for intravenous use only.
VAPRISOL is for use in hospitalized patients only.
Administration of VAPRISOL through large veins and change of the infusion site every 24 hours are recommended to
minimize the risk of vascular irritation.
VAPRISOL therapy should begin with a loading dose of 20 mg IV administered over 30 minutes.
The loading dose should be followed by 20 mg of VAPRISOL administered in a continuous intravenous infusion over
24 hours. Following the initial day of treatment, VAPRISOL is to be administered for an additional 1 to 3 days in a continuous infusion of 20 mg/day. If serum sodium is not rising at the desired rate, VAPRISOL may be titrated upward to a dose of 40 mg daily, again administered in a continuous intravenous infusion.
The total duration of infusion of VAPRISOL (after the loading dose) should not exceed four days. The maximum
daily dose of VAPRISOL (after the loading dose) is 40 mg/day.

SIDE EFFECTS
The most common adverse reactions reported with VAPRISOL administration were infusion site reactions. In studies
in patients and healthy volunteers, infusion site reactions occurred in 73% and 63% of subjects treated with VAPRISOL 20 mg/day and 40 mg/day, respectively, compared to 4% in the placebo group. Infusion site reactions were the most common type of adverse event leading to discontinuation of VAPRISOL. Discontinuations from treatment due to infusion site reactions were more common among VAPRISOL-treated patients (3%) than among placebo-treated patients (0%). Some serious infusion site reactions did occur.
The adverse reactions presented in Table 5 are derived from 72 healthy volunteers and 243 patients with euvolemic
or hypervolemic hyponatremia who received VAPRISOL 20 mg IV as a loading dose followed by 40 mg/day IV for 2 to 4 days, from 37 patients with euvolemic or hypervolemic hyponatremia who received VAPRISOL 20 mg IV as a loading dose followed by 20 mg/day IV for 2 to 4 days in an open-label study, and from 40 healthy volunteers and 29 patients with euvolemic or hypervolemic hyponatremia who received placebo. The adverse reactions occurred in at least 5% of patients treated with VAPRISOL and at a higher incidence for VAPRISOL-treated patients than for placebo-treated patients.

Storage
VAPRISOL in INTRAVIA Plastic Containers should be stored at 25°C (77°F); however, brief exposure up to 40°C
(104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light until ready to use.

  2005年12月29日,日本安斯泰来制药株式会社美国子公司在美申报的低钠血症治疗药VAPRISOL(开发代码:YM087)对体液正常型的低钠血症的适应症获得批准。这是世界上第一个治疗低钠血症的药物。
  低钠血症系相对于体内总钠量而言,总体液量过剩的疾病,从全身钠量和总体液量的关系来分,大致可分为体液正常型、体
液贮留型和体液减少型。据报道,低钠血症是在住院患者电解质异常中出现最频繁的症状,在美国每年有3,000万人以上的患者,约占全部住院患者的4%。由于重度低钠血症甚至危及生命,故被作为需要紧急治疗的疾病,但迄今为止尚无有效的治疗药物。
  VAPRISOL系安斯泰来制药创制的具有加压素(垂体后叶分泌的收缩血管的激素,vasopressin)V1a及V2受体拮抗作用的注射
剂。通过对加压素受体的拮抗作用来减少体内贮留水份,从而改善患者血中钠浓度。
    2007年,日本安斯泰来制药宣布,美国FDA批准其血钠/水失调药物Vaprisol增加适应症。
    Vaprisol于2005年首次获得FDA批准,用于治疗euvolemic型低血钠症,即无水肿性低血钠。此次,FDA又批准该药用于治疗血
容量过多型低血钠症,即水肿性低血钠。

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详细处方信息以本药内容附件PDF文件(20101509404630.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-1-12
附件:






20101509404630.pdf    

 
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