Sepracor公司于3月11日宣布FDA已批准该公司的新药Xopenex HFA吸入式气雾剂的新药申请。该药是一种氢氟烷刻度剂量式吸入剂,用于治疗或预防患者有可逆性障碍呼吸道疾病患者(包括4岁以上儿童的支气管痉挛)。可逆性障碍呼吸道疾病包括各种呼吸道紊乱,如哮喘和慢性障碍性肺病。
2003年Sepracor公司完成了该药的Ⅲ期临床试验,结果表明患者对该药的耐受性较好,主要呼吸道功能指标FEV1也显示了显著性地改善.
What is XOPENEX HFA used for?
XOPENEX (zō–pen-eks) HFA is used to treat or prevent narrowing of airways (bronchospasm) in patients 4 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 may include: coughing, wheezing, chest tightness, and shortness of breath.
Important Safety Information:
Like other inhaled beta-agonists, XOPENEX HFA can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
While you are using XOPENEX HFA Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by your healthcare provider.
XOPENEX HFA 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 HFA 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 HFA. 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 HFA 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 HFA
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 HFA 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 HFA?
(This is not a complete list of side effects reported with XOPENEX HFA. Your healthcare provider can discuss with you a more complete list of side effects.)
Common adverse effects include palpitations, chest pain, rapid heart rate, tremor, and nervousness.
Side effects of XOPENEX HFA may depend on the number of actuations used within a given time period. XOPENEX HFA may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX HFA taken?
XOPENEX HFA is administered by the use of a pressurized metered-dose inhaler, which produces a fine mist that can be inhaled. Your healthcare provider will instruct you on the correct use of your metered-dose inhaler and also give you written instructions. The usual dose of XOPENEX HFA is 2 inhalations repeated every 4 to 6 hours. One inhalation every four hours may be sufficient in some patients. It is very important that you use XOPENEX HFA as directed by your healthcare provider.
XOPENEX HFA Patient's Instructions for Use
How is XOPENEX HFA stored?
Store XOPENEX HFA at room temperature (68-77°F). Protect from freezing temperatures and direct sunlight. Store with the actuator (or mouthpiece) down. The contents are under pressure. Do not puncture or incinerate. Exposure to temperatures above 120˚F may cause bursting. Avoid spraying in eyes. Keep out of reach of children.
What are the inactive ingredients in XOPENEX HFA?
The inactive ingredients are propellant HFA-134a (1,1,1,2-tetrafluoroethane), dehydrated alcohol USP, and oleic acid NF.
于2010-04-26更新