药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20118500464838.pdf、20118500465718.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文氟替卡松处方资料(仅供参考)
辅舒酮(FLIXOTIDE) 【功效主治】用于持续性哮喘抗炎的治疗.
【化学成分】丙酸氟替卡松。
【药理作用】丙酸氟替卡松在肺部有显著抗炎作用,对只使用支气管扩张剂或用其它预防疗法的病人,丙酸氟替卡松可减轻轻症状和阻止病情恶化,对大部分病人,在推荐剂量下本药对肾上腺功能和肾上腺储备功能无影响。因为严重哮喘可发生死亡,病人需要定期进行医疗评估,严重病人有持续的症状并常常恶化,体力受限,PEF基础值低于预测值的60%,变异性大于30%,给予支气管扩张剂后通常不能完全恢复正常,这些病人将需要高剂量的吸入或口服皮质激素治疗,症状突然加重可能需要增加皮质激素剂量,这种剂量应当在紧急的医疗监护下给药。预防用于:成人:轻度哮喘;间断而不是偶然需用对症治疗的支气管扩张剂的病人;中度哮喘;常规无原则用抗药物和当前的预防治疗或单用支气管扩张剂其哮喘不稳定或恶化的病人;严重哮喘儿童:任何需要哮喘预防治疗的儿童,包括现在的预防疗法不能控制的病人。
【药物相互作用】由于首过代谢作用和肠及肝中细胞色素酶P4503A4的高系统清除作用,通常,吸入后丙酸氟替卡松的血药浓度很低。因此,不会出现具有临床意义的由丙酸氟替卡松引起的药物相互作用。一项在健康志愿者中进行的药物相互作用的临床试验显示,利托那韦(ritonavir,一种CYP3A4肝酶强抑制剂)可使丙酸氟替卡松血药浓度大幅度增加,导致血清皮质醇浓度的明显降低。曾有同时接受丙酸氟替卡松和利托那韦治疗的病人出现具有临床意义的药物相互作用,导致系统糖皮质激素效应,包括库兴氏综合征(Cushing'sSyndrome)及肾上腺功能抑制。因此,应避免将丙酸氟替卡松与利托那韦合用。只有当病人对药物的预期收益超过可能产生系统糖皮质副反应时,才能考虑同时给予丙酸氟替卡松和利托那韦。研究表明,其它细胞色素酶P4503A4的抑制剂对丙酸氟替卡松系统暴露量增加无影响(红霉素)和轻微影响(酮康唑),血清皮质醇浓度无明显降低。然而,同时服用P4503A4肝酶强抑制剂(如,酮康唑)时,应注意有可能造成丙酸氟替卡松系统暴露的增加。
【不良反应】某些病人出现口腔和咽部魄念珠菌感染,这样的病人于吸入后用水漱口可能是有益的,可在用丙酸氟替卡松继续吸入的同时局部用抗霉菌药治疗魄念珠菌感染。某些病人吸入丙酸氟替卡松可能引起嗓音嘶哑,吸入后立即用水漱口可能是有益的,与其它吸入疗法一样,给药后由于喘息立刻增加可出现相反的支气管痉挛,此时应立即吸入速效支气管扩张剂,立即停用丙酸氟替卡松气雾剂,检查病人,如需要,改用其它疗法。
【禁忌症】对任何种类的丙酸氟替卡松有过敏史的病人禁用丙酸氟替卡松气雾剂。
【用法用量】丙酸氟替卡松气雾剂仅供吸入用:应使病人明了吸入丙酸氟替卡松疗法的预防性质,即使无症状也应定期使用,4-7天显效轻度哮喘:100-250ug,每天2次中度哮喘:250-500ug,每天2次重度哮喘:500-1000ug,每天2次然后可依每个病人的效果调整剂量至哮喘控制或降低至最小有效剂量另一种方法是,丙酸氟替卡松的开始剂量以定量气雾剂给药时的丙酸掊氯米松日剂量之半为标准或相当量。4岁以上儿童:50-100ug,每天2次。特殊病人:老年人或肝肾功能障碍病人不需调整剂量.
【贮藏方法】避光,密闭,在阴凉处保存.
【注意事项】哮喘的控制应按照阶梯治疗原则进行,病人的情况应通过临床和肺功能试验进行监测。如需增加速效吸入型β2-激动剂以减轻症状,则表明对哮喘控制的恶化。在这种情况下,应重新评估病人的治疗方案,并应考虑增加抗炎治疗(例如,吸入更高剂量的或口服一个疗程的皮质激素)。严重恶化的哮喘必须采取常规治疗方案。在对哮喘控制中,哮喘的突发性和进行性恶化是致命的,应考虑增加糖皮质激素的剂量。若病人病情危险,则应考虑监测每日晨起峰流速。无效或哮喘严重恶化时应增加吸入丙酸氟替卡松的剂量。如需要,应给予全身用糖皮质激素治疗和/或抗生素治疗(如有感染)。本吸入气雾剂主要用于哮喘长期的常规治疗而不适用于缓解急性哮喘症状,病人此时应该选用快速短效的吸入型支气管扩张剂。建议病人备有上述急救药。不可突然中断本吸入气雾剂的治疗。非常罕见血糖水平增高(参见“不良反应”)的报道。对有糖尿病史的病人,应考虑其可能性。与其它吸入型糖皮质激素一样,应特别慎用于那些活动期或静止期肺结核的病人。应经常检查患者使用气雾剂装置的技术,确认给药与吸药同时进行以保证药物可最大程度到达肺部。可能的系统作用,包括肾上腺功能,骨密度及生长:吸入型糖皮质激素均有可能引起全身作用,特别是当大剂量长期使用时(参见“药物过量”)。但其发生率较口服糖皮质激素要少得多。可能的全身作用包括库兴氏综合征(Cushing'sSyndrome),库兴样特征(Cushingoidfeatures),肾上腺抑制,儿童和青少年的生长发育迟缓,骨矿物质密度减少,白内障和青光眼。因此,将剂量减少至可有效控制哮喘的最低剂量是非常重要的(参见“不良反应”)。建议定期监测长期接受吸入型糖皮质激素治疗的儿童的身高。如果发现生长减慢,应考虑是否可以减少吸入型糖皮质激素至有效控制哮喘的最低剂量,并应考虑请儿童呼吸病专家来进行评估。长期大剂量接受吸入型糖皮质激素,特别是高于推荐剂量,会引起有临床意义的肾上腺抑制。另外,在紧急情况下或择期手术当中,应考虑附加给予全身糖皮质激素治疗。内外科急症:对于原来接受过其它高剂量吸入糖皮质激素和/或间歇使用口服糖皮质激素治疗的内外科急症病人,在改为吸入型丙酸氟替卡松治疗时,肾上腺储备损害的危险在一段时间内仍会存在。发生不良反应的可能性将会持续相当一段时间。这类病人在选择方案前应接受特别的检查以确认肾上腺损害的程度。在急症和可能会引起应激的择期治疗期间,应考虑肾上腺损害的可能性,并选择合适的糖皮质激素治疗。对于曾接受口服糖皮质激素治疗的病人:对于口服激素依赖的病人,当改用本吸入气雾剂及其后续治疗时,应给予特别关照,因为长期全身激素治疗导致的肾上腺功能损害的恢复可能需要相当长一段时间。长期或大剂量使用全身激素治疗的病人,肾上腺功能可能会发生抑制,对于此类病人,应定期监测其肾上腺皮质功能并谨慎地减少全身激素的剂量。约1周后,可以开始逐渐撤除全身激素的作用。减幅应适当根据全身激素的维持剂量水平,以不低于1周的间隔进行。使用强的松龙(或等效的药物)每天维持剂量为10mg或以下的病人,其减少的剂量不应多于每天1mg,亦不可少于1周的间隔。使用强的松龙维持剂量为每日10mg以上的病人,可以谨慎地以1周的间隔,较大的幅度递减剂量。在撤除全身激素的过程中,一些病人尽管可以维持其呼吸功能甚至其肺功能得到了改善,但仍会感觉不好。应鼓励他们坚持使用吸入型丙酸氟替卡松,并继续撤除全身糖皮质激素的治疗,除非出现肾上腺功能不全的客观体征。已撤除服用激素的病人,若肾上腺皮质功能损害仍然未康复,应随身携带激素警告卡表明病人处于应激状态,例如哮喘恶化、肺部感染、主要的并发疾病、手术或外伤等情况下,需补充全身用激素。由全身性糖皮质激素治疗改为吸入治疗有时会暴露出过敏疾患,如过敏性鼻炎或曾用全身给药控制的湿疹。应用抗组胺药和/或局部制剂,包括局部皮质激素对症治疗。罕见事例表明,吸入治疗可引起潜在的嗜酸性疾病(例如Churg-Strauss综合征)的发病。这多与口服糖皮质激素治疗的减少或撤除有关。尚未建立直接的因果关系
Flixotide® What Flixotide inhalers ('puffers') are used for You may know your Inhaler better as a 'puffer'. Flixotide puffers contain a medicine called fluticasone propionate. This medicine belongs to a group of medicines known as corticosteroids, frequently called 'steroids'. They are not 'anabolic steroids' which are the steroids sometimes misused by athletes.
Your Flixotide puffer provides a measured amount of steroid for you to breathe into your lungs. By using your Flixotide puffer regularly every day, the medicine reduces the swelling and irritation in the walls of the small air passages in your lungs. Your Flixotide puffer contains the type of asthma medicine known as a 'preventer'. It does not give immediate relief from an asthma attack and may take up to a week to start to work. If your shortness of breath or wheeze does not get better after 7 days, tell your doctor. When used every day, your Flixotide puffer helps to ease breathing problems and prevent asthma attacks.
This medicine is only one part of a general plan to help you manage your asthma. You should discuss this plan with your doctor. You may also be using a 'reliever puffer'. Keep using it according to your doctor's advice. Ask your doctor to check your treatment regularly.
Ask your doctor if you have any questions about why a Flixotide puffer has been prescribed for you.
The medicine in Flixotide puffers is not addictive.
Flixotide puffers generally do not cause any problems with your ability to drive a car or operate machinery.
Flixotide (fluticasone propionate) is available in Inhaler 25, 50, 125 or 250 micrograms per actuation and Accuhaler 50, 100, or 250 micrograms per actuation. Flixotide inhalers are fully funded medicines, normal pharmacist fees apply. Flixotide Accuhaler is not fully funded; a part charge will apply. Prescription Medicine for the prevention of asthma. Use strictly as directed. Do not use Flixotide if you: have ever had an allergic reaction to fluticasone or lactose; or for sudden attacks of breathlessness. Always carry your reliever inhaler for use during acute attacks. Tell your doctor if you: are taking other medicines or herbal remedies; have had to stop taking other asthma medicines; have tuberculosis (TB) or other long-term lung infection. Do not discontinue Flixotide suddenly without consulting with your doctor. Side Effects may include: sore throat or tongue, hoarseness or throat irritation, skin reactions, shortness of breath and wheezing. Tell your doctor or pharmacist immediately if you have any concerns. If symptoms continue or you have side effects see your doctor, pharmacist or health professional. Ask your doctor if Flixotide is right for you.
Flixotide and Accuhaler are trade marks of the GlaxoSmithKline group of companies. Marketed by GlaxoSmithKline NZ Limited, Auckland. TAPS DA89KH/08MY/066
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20118500464838.pdf、20118500465718.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |