PULMICORT RESPULES(budesonide)-是唯一的一个激素喷雾剂。近日获美国FDA批准用于哮喘的维持治疗和12个月至8岁儿童的预防性治疗。布地奈德吸入悬浮液不适用于缓解急性支气管痉挛。 批准日期：2016年11月  公司：AstraZeneca PULMICORT RESPULES（布地奈德budesonide）吸入悬浮液  用于吸入使用 美国最初批准：2000年 作用机制 布地奈德是一种抗炎皮质类固醇，具有强大的糖皮质激素活性和弱的盐皮质激素活性。在标准的体外和动物模型中，布地奈德对糖皮质激素受体的亲和力大约高200倍，与皮质醇相比具有1000倍的局部抗炎效力（大鼠巴豆油耳水肿测定）。作为全身活性的量度，布地奈德在皮下给药时比皮质醇强40倍，在大鼠胸腺退化试验中口服给药时效力高25倍。这些发现的临床意义尚不清楚。 PULMICORT RESPULES的活性归因于母体药物布地奈德。在糖皮质激素受体亲和力研究中，22R形式的活性是22S差向异构体的两倍。体外研究表明，两种形式的布地奈德不会相互转化。 皮质类固醇对哮喘炎症的作用的确切机制尚不清楚。炎症是哮喘发病机制中的重要组成部分。已显示皮质类固醇具有广泛的针对多种细胞类型（例如肥大细胞，嗜酸性粒细胞，中性粒细胞，巨噬细胞和淋巴细胞）的抑制活性以及参与过敏性和/或介导的介质（例如，组胺，类二十烷酸，白三烯和细胞因子）。非过敏性介导的炎症。皮质类固醇的抗炎作用可能有助于它们在哮喘中的功效。 哮喘患者的研究表明，在各种配方和输送系统中，局部抗炎活性与全身皮质类固醇对大剂量吸入布地奈德的影响有利，包括吸入驱动，多剂量干粉吸入器和吸入用于雾化的悬浮液。这可以通过相对高的局部抗炎作用，口服吸收药物的广泛首过肝降解（85-95％）和代谢物的低效力（见下文）的组合来解释。 适应症和用法 PULMICORTRESPULES®是一种吸入性皮质类固醇，适用于： •对12个月至8岁的儿童进行哮喘的维持治疗和预防性治疗。 使用限制： 未表明可缓解急性支气管痉挛。 剂量和给药 基于先前疗法的推荐剂量。从最低推荐剂量开始： •单独支气管扩张剂：每日0.5mg或每日两次0.25mg •吸入皮质类固醇：每日0.5mg或每日两次0.25mg至每日两次0.5mg •口服皮质类固醇：每日两次0.5mg或每日一次1mg •对于对非甾体治疗无反应的有症状儿童，可考虑每日一次0.25 mg的起始剂量。 •如果每日一次治疗无法提供足够的控制，则应增加每日总剂量和/或以分剂量给药。一旦达到哮喘稳定性，向下滴定剂量 •仅适用于通过压缩空气驱动的喷射雾化器进行吸入（不适用于超声波装置）。不是为了注射。 剂量形式和强度 吸入悬浮液：0.25mg/2mL，0.5mg/2mL，1mg/2mL。 禁忌症 •需要采取强化措施的哮喘状态或其他哮喘急性发作的初级治疗。 •对PULMICORT RESPULES中的任何成分过敏。 警告和注意事项 •局部感染：可能发生白色念珠菌感染口腔和咽喉。定期监测患者口腔不良反应的迹象。建议患者在吸入后冲洗口腔。 •疾病和急性哮喘发作的恶化：不要用于缓解急性支气管痉挛。 •超敏反应：使用PULMICORT RESPULES报告了过敏反应，皮疹，接触性皮炎，荨麻疹，血管神经性水肿和支气管痉挛。如果发生此类反应，请停止使用PULMICORT RESPULES。 •免疫抑制：感染的潜在恶化（例如，现有的结核病，真菌，细菌，病毒或寄生虫感染;或单纯的单纯疱疹）。对这些感染患者慎用。易感患者可能出现更严重甚至致命的水痘或麻疹病程。 •转移患者从系统性皮质类固醇治疗：从口服类固醇转移时肾上腺功能受损的风险。如果转移到PULMICORT RESPULES，则从全身性皮质类固醇缓慢减量。 •高频率和肾上腺抑制：可能在非常高的剂量下或在易感个体的常规剂量下发生。如果发生此类变化，请缓慢减少PULMICORT RESPULES。 •长期服用可降低骨密度：监测患者骨矿物质含量下降的主要危险因素。 •对生长的影响：监测儿科患者的生长情况。 •青光眼和白内障：保证密切监测。 •矛盾的支气管痉挛：如果出现反常的支气管痉挛，则停止使用PULMICORT RESPULES并进行替代治疗。 •嗜酸性粒细胞疾病和Churg-Strauss综合症：警惕嗜酸性粒细胞疾病。 不良反应 最常见的不良反应（发生率> 3％）是呼吸道感染，鼻炎，咳嗽，中耳炎，病毒感染，念珠菌，胃肠炎，呕吐，腹泻，腹痛，耳部感染，鼻出血，结膜炎，皮疹。 药物相互作用 强细胞色素P450 3A4抑制剂（如利托那韦）：谨慎使用。可能导致全身皮质类固醇激素增加。 如何提供/存储和处理 PULMICORT RESPULES提供密封铝箔信封，其中包含一个塑料条，包含五个单剂量RESPULES安瓿，以及患者使用说明。纸箱中有30个RESPULES安瓿。每个单剂量RESPULES安瓿含有2毫升无菌液体悬浮液。 PULMICORT RESPULES有三种强度，每种含有2mL： NDC 0186-1988-04 0.25毫克/ 2毫升 NDC 0186-1989-04 0.5毫克/ 2毫升 NDC 0186-1990-04 1毫克/ 2毫升 PULMICORT RESPULES应在20-25°C（68-77°F）的受控室温下直立存放[见USP]，并避光。打开信封时，未使用的RESPULES安瓿的保质期为2周。打开铝箔外壳后，未使用的RESPULES安瓿应返回铝箔外壳，以防止光照。必须立即使用任何打开的RESPULES安瓿。使用前，使用圆周运动轻轻摇动RESPULES安瓿。请将本品放在儿童不能接触的地方。不要冻结。 完整说明资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33cd9834-76df-4f26-3fa2-aab6b9eee8f2 --------------------------------------------- 注：以下产品是美国上市包装，不现规格和不同价格。 ---------------------------------------------- PULMICORT FLEXHLR 90MCG 60DS  BUDESONIDE  ASTRA/ZENECA PHARMACEUT  00186-0917-06  PULMICORT FLEXHLR 180MCG 120DS  BUDESONIDE  ASTRA/ZENECA PHARMACEUT  00186-0916-12    PULMICORT RESPULE 1MG/2ML 30 BUDESONIDE  ASTRA/ZENECA PHARMACEUT  00186-1990-04   PULMICORT RESPULE .25MG/2ML 30 BUDESONIDE  ASTRA/ZENECA PHARMACEUT  00186-1988-04 PULMICORT RESPULE 0.5MG/2ML 30 BUDESONIDE  ASTRA/ZENECA PHARMACEUT  00186-1989-04 -------------------------------------------------- The first new drug to treat asthma in children and 12-month-old babies is FDA-approved, Pulmicort Respules(TM), the only hormone spray, and AstraZeneca today announced that the company's asthma drugs for infants and babies have been acquired. Approved by the US Food and Drug Administration (FDA). The drug, called Pulmicort Respules, is the first asthma treatment approved for use in children and 12-month-old babies, and is the first and only hormone. Spray dosage form. In the past, hormone inhalation therapy was only available for children over 4 years of age, and children often did not use it properly. Dr. Frank Casty, executive director of the company's Department of Respiratory Diseases and Inflammation, said that Pulmicort Respules pioneered a new approach to hormones. "The approval of the drug has enabled clinicians to add new tools to the treatment of infant asthma with inhaled hormones." Pulmicort Respules is permeable and can be used to control asthma in infants from 1 to 8 years of age. It is not a rapidly released dosage form (bronchodilator) and therefore should not be used in the initial treatment of asthma attacks. This medicine can be purchased in the pharmacy by prescription in October this year. Meet current medical needs According to Dr. David Skoner, director of the Department of Allergy and Immunology at the Children's Hospital of Pittsburgh, asthma is one of the most common chronic diseases in pediatrics, and the disease is on the rise worldwide among children. (1) In the United States, approximately 5 million children are suffering from asthma; (2) About 80% of children before the age of 5 have asthma symptoms; (3) "Before the appearance of Pulmicort Respules, there is limited or no anti-inflammatory treatment for infant asthma. There is no treatment at all." For infants and young children, current anti-inflammatory treatments do not use oral hormones (tablets or syrups) or non-hormonal sprays. Skoner emphasized that "Pulmicort Respules is a milestone in the treatment of children with persistent asthma." Asthma is a severe inflammatory lung disease. For children with asthma, the development of hormone therapy is imperative. Clinical studies confirm that Pulmicort Respules is safe and effective According to three 12-week double-blind clinical trials in 946 children aged 1 to 8 years with mild to moderate persistent asthma in the United States, Pulmicort Respules received FDA approval. This medicine can reduce the need for bronchodilators and can improve asthma symptoms during the night and day. In clinical trials, the most common side effects are respiratory infections, salivation, cough, earache, viral infections, stomach and ear infections, and discomfort without medication. The incidence of side effects was basically the same as that of the non-drug treatment group. Pulmicort Respules has been on the market since 1990 and is currently used in 55 countries. Its main ingredient, budesonide, has been used to treat asthma for more than 15 years. Pulmicort Turbuhaler (Budesonide Inhalation Powder) is the first dry powder formulation promoted by AstraZeneca. In 1998, the use of hormone-free sprays without CFC began in the United States. Inflammatory Therapy, a guide to asthma treatment developed by the National Institutes of Health (NIH) emphasizes that inhaled hormones should be used to control airway inflammation. The development of inhaled hormones allows clinicians to directly treat airway inflammation. NIH's panel of experts on asthma diagnosis and treatment II pointed out that inhaled hormonal therapy is the best measure to control persistent asthma. Dr. Skoner said, “Pulmicort Respules has received FDA approval for clinicians, parents and their children. This is an encouraging news. In my experience, this drug is a leap forward in improving asthma symptoms in infants and young children.” Dr. Skoner pointed out that asthma must be treated appropriately - otherwise children may be threatened with life. Of course, children with asthma should be monitored when taking inhaled hormones so that the efficacy and side effects of the drug can be assessed. The dose of inhaled hormone should be reduced to the minimum dose required to control asthma. If asthmatic children discontinue oral hormones (tablets or syrups) and switch to Pulmicort Respules, they must be closely monitored to prevent withdrawal of the hormone. Practical spray therapy, for infant asthma, aerosol inhalation is a common route of medication. Pulmicort Respules is the first spray formulation approved for use in the United States. The spray can uses compressed air to atomize Pulmicort Respules. The child can inhale the drug through a mask attached to the nebulizer. The drug is a colorless, odorless liquid that is stored in a spray can that can be unscrewed by a parent. Take Pulmicort Respules once or twice daily. Dr. Skoner said, "For infant asthma, this hormone aerosol inhalation is very useful and effective.