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 详细处方信息以本药内容附件PDF文件（201242220402211.pdf）的“原文Priscribing Information”为准
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部分中文普米克处方资料（仅供参考）

阿斯利康公司用于治疗儿童和12个月大婴儿哮喘的新药获得FDA批准
    Pulmicort Respules(TM)-第一个也是唯一的一个激素喷雾剂，阿斯利康公司今天宣布该公司用于幼儿和婴儿的哮喘药物已经获得美国食品和药品管理局（U.S. Food and Drug Administration，FDA）的批准。该药品商品名为Pulmicort Respules（布地奈德吸入悬液），它是第一个唯一的获准用于儿童和12个月大婴儿的哮喘治疗药物，而且还是第一个，同时也是唯一的一个激素喷雾剂剂型。以前，激素吸入治疗仅适用于4岁以上的儿童，而且儿童往往不能正确使用。
    该公司呼吸疾病和炎症研究部门的执行主任Frank Casty医生称，Pulmicort Respules开创了激素服用新途径。“该药物获得批准使临床医生在使用吸入型激素治疗婴幼儿哮喘时又增添了新的手段。”Pulmicort Respules具有渗透性，可用于1岁到8岁婴幼儿哮喘的控制。它不是一种迅速释放的剂型（支气管舒张剂），因此不应用于哮喘发作的初期治疗。今年10月就可以在药房凭处方买到该药。

满足目前医疗需求
    匹兹堡儿童医院变态反应和免疫科主任David Skoner博士称，哮喘是最常见的儿科慢性疾病之一，全球范围内该病在儿童中呈上升趋势。(1) 在美国，大约有5百万儿童受到哮喘困扰；(2) 5岁前的儿童大约有80%出现哮喘症状；(3) “在Pulmicort Respules出现之前，对于婴幼儿哮喘，要么抗炎治疗十分有限，要么根本没有治疗措施”。对于婴幼儿患者，目前的抗炎治疗并没有使用口服激素（片剂或糖浆）或非激素类的喷雾剂型。
    Skoner强调，“Pulmicort Respules是儿童持续哮喘治疗的一个里程碑”。哮喘是一种重症炎症性肺部疾病，对于儿童哮喘，激素治疗的发展是势在必行的。

临床研究证实Pulmicort Respules是安全有效的
    根据在美国对946例1岁到8岁患有轻度到中度持续性哮喘的儿童进行的三个12周的双盲临床试验的结果，Pulmicort Respules获得了FDA的批准。该药可以减少对支气管舒张剂的需要，而且可以改善夜间和白天的哮喘症状。在临床试验中，最常见的副作用是呼吸道感染、流涕、咳嗽、耳痛、病毒感染、胃痛和耳朵感染以及无须药物治疗的不适。副作用发生率和非药物治疗组基本一致。
    自1990年Pulmicort Respules就已经上市，目前在55个国家广泛应用。其主要成分-布地奈德，用于治疗哮喘已经超过了15年。Pulmicort Turbuhaler（布地奈德吸入粉剂）是阿斯利康公司推广的第一个干粉制剂。1998年在美国就开始使用无CFC的激素喷雾剂。
    炎症治疗作用，美国国家卫生研究所（National Institutes of Health，NIH）制订的哮喘治疗指南强调应该使用吸入型激素控制气道炎症。吸入型激素的开发研制使临床医生能够直接针对气道炎症进行治疗。NIH关于哮喘诊断和治疗的专家小组报告II指出，吸入型激素治疗是控制持续性哮喘的最佳措施。Skoner医生称，“对于临床医生、家长及其孩子，Pulmicort Respules获得FDA批准是一个鼓舞人心的消息。根据我的经验，该药对改善婴幼儿哮喘症状是一个飞跃。”
    Skoner医生指出，哮喘必须得到适宜的治疗-否则儿童可能受到生命威胁。当然，哮喘患儿在服用吸入型激素时应当受到监护，这样就可以对该药物的疗效和副作用进行评估。吸入型激素的剂量应该降低到控制哮喘所需的最小剂量。如果哮喘患儿停用口服激素（片剂或糖浆）而改用Pulmicort Respules，他们必须受到严密监护以防出现停用激素的戒断反应。
    实用性的喷雾治疗，对于婴幼儿哮喘，雾化吸入是常用的服药途径。Pulmicort Respules是第一个获得批准在美国广泛使用的喷雾剂剂型。该喷雾罐使用压缩空气使Pulmicort Respules（水基药物）雾化。       患儿可通过连接在喷雾器上的面罩吸入该药物。该药是无色无味的水剂，贮存于一个家长才能拧开的喷雾罐中。服用Pulmicort Respules可每日一次或两次。Skoner医生称，“对于婴幼儿哮喘，此激素雾化吸入非常使用且有效。”

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普米克气雾剂 【Pulmicort】
【分类】平喘药

【别名】布地奈德气雾剂

【外文名】Pulmicort

【药理作用】含有布地奈德的气雾剂是一种非卤代化的糖皮质激素，由于布地奈德具有极高的(90%)肝脏首过代谢效应，故在较大的剂量范围内，该药对局部抗炎作用具有良好的选择性。在动物与患者的诱发实验中显示，布地奈德具有抗过敏抗炎作用，能缓解对即刻及迟发过敏反应所引起的支气管阻塞。在高反应性病人，布地奈德具有降低气道对组胺和乙酰甲胆碱的反应，还可以有效地预防运动性哮喘的发作。对所有哮喘都有效，局部抗炎效能是BDP的二倍.90%咽下部分迅速灭活，半衰期只有2小时，体内灭活比BDP快4-5倍.长期应用尤为适宜，全身作用少.2小时比15小时体内代谢比BDP快4-5倍，很高的首过代谢率普米克(布地奈德)200mg，1喷bid>50mg/喷，2喷qid<50mg/喷，4喷qid病人的依从性来自于最少的给药次数及每次给药的最少喷数。

【用法用量】成人：200-1600mg/天分2-4次使用(较轻微病例200-800mg/天，较严重则800-1600mg/天)2-7岁儿童：200-400mg/天分2-4次使用。7岁以下儿童：200-800mg/天分2-4次使用。

【不良反应】喉部轻微刺激、咳嗽和声嘶，咽部念珠菌感染已有报道。

【规格】10ml：10mg，50mg/喷200喷/瓶10ml：20mg，100mg/喷200喷/瓶5ml：20mg，200mg/喷100喷/瓶

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IMPORTANT INFORMATION ABOUT PULMICORT FLEXHALER
Important Safety Information
PULMICORT FLEXHALER is not a bronchodilator and should NOT be used to treat an acute asthma attack. If you are switching to PULMICORT FLEXHALER from an oral corticosteroid, follow your doctor's instructions to avoid serious health risks when you stop using oral corticosteroids.

Avoid exposure to infections such as chicken pox and measles. Tell your doctor immediately if exposed. Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.

Rare instances of glaucoma, increased intraocular pressure, cataracts have been reported following the inhaled administration of corticosteroids.

PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur.

Be sure to tell your healthcare provider about all your health conditions, and all medicines you may be taking

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT FLEXHALER, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT FLEXHALER should be discontinued and alternate therapy instituted.

The most commonly reported side effects in clinical trials include inflammation of the nose and throat, nasal congestion, sore throat, nasal allergies, viral upper respiratory tract infection, and thrush in the mouth and throat.

Approved Use
PULMICORT FLEXHALER (budesonide inhalation powder, 90 mcg & 180 mcg), an inhaled corticosteroid, is used for the maintenance treatment of asthma in adults and children 6 years or older.

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IMPORTANT INFORMATION ABOUT PULMICORT RESPULES
Important Safety Information
PULMICORT RESPULES is not a bronchodilator and should NOT be used to treat an acute asthma attack. If your child is switching to PULMICORT RESPULES from an oral corticosteroid, follow the doctor's instructions to avoid serious health risks when your child stops using oral corticosteroids.

Only use PULMICORT RESPULES with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.

Thrush infection of the mouth and throat may occur with PULMICORT RESPULES.

Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.

Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.

PULMICORT RESPULES should not be used if your child is allergic to budesonide or any of the ingredients.

Be sure to tell the healthcare provider about all your child's health conditions and all medicines he or she may be taking.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT RESPULES, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT RESPULES should be stopped and your physician consulted.

The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.

Approved Use
PULMICORT RESPULES (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.

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 详细处方信息以本药内容附件PDF文件（201242220402211.pdf）的“原文Priscribing Information”为准
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