英文药名：Adoair Diskus（Salmeterol Xinafoate/Fluticasone Propionate） 中文药名：沙美特罗/丙酸氟替卡松复方吸入粉剂 生产厂家：葛兰素史克公司 药品介绍 哮喘·慢性阻塞性肺病的配合剂 批准上市日期：2007年6月 商標名 Adoair Diskus 一般名 サルメテロールキシナホ酸塩（Salmeterol Xinafoate） 化学名 (RS)-1-(4-Hydroxy-3-hydroxymethylphenyl)-2-[6-(4-phenylbutoxy)hexylamino]ethanol 1-hydroxy-2-naphthoate 分子式 C25H37NO4・C11H8O3 分子量 603.75 構造式 性状 这是一个很好的白色粉末。 它是易溶于二甲亚砜，容易微溶于甲醇，和微溶于乙醇（99.5），极微溶于乙腈中，并在乙醚或几乎不溶于水。 此产品（1→50）的二甲基亚砜溶液显示无旋光性。 分配系数（logP值） 2.0（pH7.4,1-辛醇/水） 一般名 フルチカゾンプロピオン酸エステル（Fluticasone Propionate） 化学名 S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrost-1,4-diene-17β-carbothioate 分子式 C25H31F3O5S 分子量 500.57 構造式 性状 这是一个很好的白色粉末。 它是易溶于二甲亚砜，微溶于氯仿或乙腈中，微溶于乙醇或甲醇（99.5），极微溶于乙醚，并在实际上不溶于水。 分配系数（logP值） 4.6（pH7.0,1-辛醇/水） 【药理作用】 参见“沙美特罗/丙酸氟替卡松的原处方”，两药合用可有效改善症状，并可防止病情恶化。 【适应症】 用于可逆性阻塞性气道疾病的常规治疗。包括成人和小儿哮喘。 【用法用量】 经口吸人，成人及12岁以上者：一次1吸(沙美特罗50μg和丙酸氟替卡松100μg)，一日2次，或一次1吸(沙美特罗50μg和丙酸氟替卡松250μg)，一日2次。4岁以上小儿：一次1吸(沙美特罗50μg和丙酸氟替卡松100μg)，一日2次。 【注意事项】 (1)对本品中任何成分有过敏史者禁用。 (2)活动期或静止期肺结核患者慎用。孕妇及哺乳期妇女慎用。只有在预期对母亲的益处超过任何对胎儿或孩子的可能危害时才考虑用药。 (3)本品不适于治疗急性哮喘症状。任何吸入型皮质激素都有可能引起全身反应，特别是长期大剂量使用，但其出现与口服皮质激素相比要少得多，故本品剂量应逐渐调至可有效控制病情的最小维持剂量。 (4)建议长期接受吸入型皮质激素治疗的小儿定期检查身高。 (5)由于存在肾上腺反应不足的可能，患者在由口服皮质激素转为吸入皮质激素时，应特别慎重，并定期检测肾上腺皮质激素功能。 【药物相互作用】 患可性行气道阻塞性疾病的患者，除非迫不得已，应避免使用选择性及非选择性β受体阻滞药。 【不良反应】 详见“沙美特罗/氟替卡松原处方。 生产商：葛兰素史克日本公司 Adoair Diskus（Salmeterol Xinafoate/Fluticasone Propionate） Effects of this medicine This medicine is a combination inhaler of long-acting bronchodilator and steroidal anti-inflammatory agent which suppresses inflammation in the airways. It dilates bronchi and suppresses inflammation over a long time, and consequently relieves severity and frequency of asthma attacks. It is usually used in the treatment of bronchial asthma. It is not effective for sedating an asthma attack which has already developed.  Before using this medicine, tell your doctor/pharmacist If you ever experienced allergic reaction (itch, rash etc.) to this medicine by inhaling. If you are a patient with tuberculosis, infections (except cold etc.), deep mycosis, hyperthyroidism, hypertension, cardiac disease, or diabetes. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) Your dosage regimen is:(order of your doctor) Usually adults should be given one inhalation into the mouth at a time, twice daily. The medicine can be replaced with high-dose preparation (Diskus 250 or 500) depending on the symptoms. Children should be given one inhalation into the mouth at a time, twice daily. You can use this medicine up to two inhalations per day. Strictly follow the specified instructions in any case. Read the instruction for users "How to inhale Adoair Diskus" thoroughly before using the medicine. Gargle the throat after inhaling. (If you are hard to gargle, rinse out your mouth.) Missed dose: Inhale a dose as soon as possible when you remember that you missed a dose. If it is almost time for the next dose, skip the next dose. DO NOT inhale a double dose to make up for the missed dose. Overdose: If you inhaled too much of the medicine, check with your doctor/pharmacist. Others: Do not stop inhaling the medicine without the instructions of your doctor. Precautions while using this medicine When you experience an asthma attack, take prescribed medicine for stopping an attack, or visit a healthcare facility as soon as possible. Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hoarseness (hoarse voice), oral or pharyngeal candidiasis, irritation in the mouth or throat (abnormal feeling, pain, uncomfortable feeling), infection, rash, urticaria, angioedema (swelling in the eyes or lips), muscle spasm, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. Dyspnea, hives, cold sweat[shock, anaphylactoid symptoms] Lassitude, loss of muscular strength, numbness/tremor in the limbs[low serum potassium level] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.  Storage and other information Keep out of the reach of children. Store away from heat, moisture and direct sunlight. If any medicines are left, do not store and discard them. For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical DevicesAgency. 完整资料附件：http://www.info.pmda.go.jp/go/pack/2290800G1032_1_04/ Adoair 500 Diskus 60 doses Adoair 500 Diskus 28 doses Adoair 50 Aerosol 120 puffs Adoair 250 Diskus 28 doses Adoair 250 Diskus 60 doses Adoair 250 Aerosol 120 puffs Adoair 125 Aerosol 120 puffs Adoair 100 Diskus 60 doses Adoair 100 Diskus 28 doses Manufacturer's name : GlaxoSmithKline K.K.