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XOPENEX(左沙丁胺醇吸入剂)

——新药Xopenex  HFA吸入式气雾剂

2005-07-25 16:46:50  作者:新特药房  来源:中国新特药网天津分站  浏览次数:181  文字大小:【】【】【

Xopenex是一种用于可逆的阻塞性气道疾病(如哮喘)的药物。1999年FDA批准此药用于成人和12岁以上的儿童患者。2002年2月FDA将此药的适用人群扩大至6岁以上的患者。

Xopenex是一吸入溶液,每天使用3次,吸入装置为Nebulizer。

支持FDA批准的是一项有史以来对β拮抗剂进行的规模最大的儿科哮喘临床研究。这项338名患者参与的双盲、安慰剂控制临床试验的目的是确定Xopenex用于儿童的安全和有效剂量。试验中测试的两种剂量在获得疗效和维持疗效方面,与对照治疗都有临床可比性。

在此药第一次被批准以前,也进行了一项评价安全性和有效性的双盲、安慰剂控制临床试验,试验对象是成人和青少年哮喘患者。从试验治疗开始到结束,此药在缓解症状方面的疗效均优于剂量较大的对照药物。

此药的副作用包括:流感样症状、心率增快、神经过敏和振颤。

Xopenex的活性成分是Levalbuterol HCL,它通过与人体气道平滑肌的β肾上腺素能受体结合,使气道扩张,起到保护作用。

 

What is XOPENEX Inhalation Solution used for?
XOPENEX (Zō–pen-eks) Inhalation Solution is used to treat or prevent narrowing of airways (bronchospasm) in patients 6 years of age and older with reversible obstructive airway disease, such as occurs in asthma or chronic obstructive pulmonary disease (COPD).

What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.

Important Safety Information:
Like other inhaled beta-agonists, XOPENEX Inhalation Solution can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.

Your healthcare provider may need to prescribe other medications in addition to XOPENEX Inhalation Solution to help control your asthma. Do not stop taking other asthma medications unless advised by your healthcare provider.

XOPENEX Inhalation Solution can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your healthcare provider will determine if XOPENEX is right for you.

Use as directed by your healthcare provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.

Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX Inhalation Solution. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.

If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.

If you currently have, or have had, a history of the following conditions, your healthcare provider will evaluate you to decide if XOPENEX Inhalation Solution is right for you:

•heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
•seizures
•high levels of thyroid hormone
•diabetes
•reactions to medications similar to XOPENEX Inhalation Solution
What should I tell my healthcare provider?
Review all medications that you are taking with your healthcare provider, including those that you take without prescription. Because of the potential to interact with XOPENEX Inhalation Solution and cause side effects, tell your healthcare provider if you are taking other medications such as:

•diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
•antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
•drugs known to affect the heart's regular rhythm
•drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your healthcare provider if you are trying to become pregnant, are already pregnant, or are nursing.

What are some possible side effects of XOPENEX Inhalation Solution?
(This is not a complete list of side effects reported with XOPENEX Inhalation Solution. Your healthcare provider can discuss with you a more complete list of side effects.)

Side effects of XOPENEX Inhalation Solution may depend on dose. XOPENEX Inhalation Solution may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX Inhalation Solution taken?
XOPENEX Inhalation Solution is administered by the use of a nebulizer (NEB-yoo-ly-zer). A nebulizer is a device that converts XOPENEX Inhalation Solution into a fine mist that can be inhaled. Your healthcare provider will instruct you on the correct use of your nebulizer and also give you written instructions. It is very important that you take your XOPENEX Inhalation Solution as directed by your healthcare provider.

XOPENEX Inhalation Solution Patient's Instructions for Use

How is XOPENEX Inhalation Solution stored?
Store XOPENEX Inhalation Solution in the protective foil pouch at room temperature (68°F - 77°F). Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the pouch is opened, the vials should be used within two weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within one week. Discard any vial if the solution is not colorless.
2011-10-03更新

原产地英文商品名:
XOPENEX-0.63mg/3ml Solution,72ml/Box
原产地英文药品名:
LEVALBUTEROL HCL
中文参考商品译名:
左沙丁胺醇-0.63毫克/3毫升吸入剂,72毫升/盒
中文参考药品译名:
左沙丁胺醇吸入剂
产地国家: 美国
所属类别: 作用于呼吸系统药物->平喘药物
处方药:处方药
包装规格: 0.63毫克/3毫升吸入剂,72毫升/盒
销售单价(美元 US$): 159美元
销售单价(人民币 RMB): 1048 元

原产地英文商品名:
XOPENEX-1.25mg/3ml Solution,72ml/Box
原产地英文药品名:
LEVALBUTEROL HCL
中文参考商品译名:
左沙丁胺醇-1.25毫克/3毫升吸入剂,72毫升/盒
中文参考药品译名:
左沙丁胺醇吸入剂
产地国家: 美国
所属类别: 作用于呼吸系统药物->平喘药物
处方药:处方药
包装规格: 1.25毫克/3毫升吸入剂,72毫升/盒
销售单价(美元 US$): 159美元
销售单价(人民币 RMB): 1048 元

计价单位:

原产地英文商品名:
XOPENEX-0.31mg/3ml Solution,72ml/Box
原产地英文药品名:
LEVALBUTEROL HCL
中文参考商品译名:
左沙丁胺醇-0.31毫克/3毫升吸入剂,72毫升/盒
中文参考药品译名:
左沙丁胺醇吸入剂
产地国家: 美国
所属类别: 作用于呼吸系统药物->平喘药物
处方药:处方药
包装规格: 0.31毫克/3毫升吸入剂,72毫升/盒
销售单价(美元 US$): 159美元
销售单价(人民币 RMB): 1048 元
计价单位:

责任编辑:


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