英文药名：Pulmicort Respules（Budesonide）

中文药名：布地奈德吸入液

生产厂家：阿斯利康

パルミコート吸入液0.25mg／パルミコート吸入液0.5mg

治疗类别名称
吸入性类固醇治疗哮喘剂
欧文商標名
Pulmicort Respules
一般名：ブデソニド（Budesonide）（JAN）
化学名：(+)-[(RS)-16α,17α-butylidenedioxy-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione]
構造式：

分子式：C25H34O6
分子量：430.53
融点：約240℃（分解）
性状：
布地奈德是白色结晶或结晶性粉末，以淡黄白色。微溶于甲醇，微溶于乙腈或乙醇（95），并且几乎不溶于水。
适应病症
支气管哮喘
用法用量
成人，每日2次，每次0.5mg-1mg，使用喷雾器吸入给药的日子。应当指出的是，虽然根据症状，每天1次的最高量和最多2mg的调整。
儿童：每天2次，每次为0.25mg-0.5mg，通过使用喷雾器吸入给药。此外，根据症状，每天1次的最高量和至多1mg的调整。
药效药理
1.哮喘的抑制作用
(1) 布地奈德，通过吸入给药到哮喘模型，立即和迟发型哮喘反应（羊），以及乙酰胆碱（狗）和血清素（鼠）吸入的刺激通过气道超敏反应被抑制，分别。
(2) 在国外的成年患者支气管哮喘，布地奈德（每日剂量浓度为1000μg，加压计量剂量吸入器）通过吸入给药的临床药理试验中，抑制了立即和迟发型哮喘反应21）。
另外，当通过吸入由每日剂量1600μg都保，胆碱给药，抑制由焦亚硫酸钠和5'-AMP中的气管收缩反应。
此外，布地奈德（每日剂量1200μg，加压计量剂量吸入器）通过吸入施用，改进以及治疗呼吸道上皮病变开始后一年内改善气道高反应性进行观察。
同样，在儿童患者与外国人的支气管哮喘，组胺PD20（FEV1（1秒率：用力肺活量，减少的量）在一开始被称为呼叫一秒钟开始20％的组胺激发量）在测得的气道高反应，布地奈德（每日剂量600μg，加压定量吸入器）通过吸入给药，观察改善是持续22个月。
2. 抗炎症作用
(1) 布地奈德，在体外试验系统中，抑制了由在哮喘肺的气道炎症的生产和显著作用多种炎症介质的释放。此外，布地奈德，在各种动物模型，吸入，通过在增加嗜酸性粒细胞计数气管内或局部给药，气道，血管通透性增加，抑制效果对炎性肺水肿形成和呼吸道粘膜纤毛转运不容忍它指出。
(2) 布地奈德，在外国健康成年（指标皮肤苍白度）的皮肤血管收缩试验中，为约两倍丙酸倍氯米松的局部抗炎作用。另外，通过吸入给药到外国成年支气管哮喘患者中，它减少了炎性细胞例如在气道上皮细胞嗜酸性粒细胞和淋巴细胞。
(3) 在大鼠中，布地奈德在气道组织的细胞产生非活性脂肪酯，非活动酯保持在气道局部时间长，活性布地奈德逐渐被细胞内的脂肪酶的作用而释放的，它表现出持久性局部抗炎效果。
3. 对全身影响
(1) 布地奈德，豚鼠，在动物模型如小鼠，与丙酸倍氯米松，在局部给药较强的抗炎作用，垂体比较 - 全身的影响，包括肾上腺抑制较弱。
(2) 在国外健康成人临床药理试验中，布地奈德（每日剂量800和2500μg，加压计量剂量吸入器）骨代谢和由吸入给药健康成人垂体 - 对肾上腺皮质功能的影响是倍氯米松它比丙酸酯弱。
此外，即使在6周的吸入1600μg使用都保给外国成年支气管哮喘患者施用日剂量垂体-它并不影响肾上腺功能。
(3) 在经由通过滴定的400μg或800μg的加压计量剂量吸入器中外来儿科支气管哮喘患者（7至15岁的年龄），布地奈德或倍氯米松为200μg丙酸酯，每四周临床药理试验连续吸入给药时，观察到剂量依赖性抑制在24小时的尿皮质醇排泄，40时倍氯米松在丙酸酯，它未在布地奈德观察到的）。外国小儿哮喘患者这种药物（6个月到8岁）当12周吸入给药1天1.0毫克，垂体 - 41并不影响肾上腺功能）。
此外，在外国儿童支气管哮喘患者（5至16岁），剂量根据哮喘布地奈德（平均剂量504μg）3〜6年，加压计量剂量吸入器和间隔的严重性进行调整，或当吸入经由都保，42是接收非甾体类治疗的对照组相比，在X如由线吸收光谱确定影响骨密度观察）。
包装规格
0.25mg：2毫升×30安瓿（铝枕式包装 1袋5安瓿×6袋）
0.5mg： 2毫升×30安瓿（铝枕式包装 1袋5安瓿×6袋）

制造厂商
阿斯利康有限公司
完整资料附件：http://www.info.pmda.go.jp/go/pack/2290701G4020_1_10/

Pulmicort Respules（Budesonide）
Pulmicort Respules 0.25mg（パルミコート吸入液0.25mg） 
Brand name : Pulmicort Respules 0.25mg
　Active ingredient: Budesonide
　Dosage form: white to slightly yellowish white, inhaler, ampuled suspension liquid 
　Print on wrapping: パルミコート吸入液0.25mg
Pulmicort Respules 0.5mg（パルミコート吸入液0.5mg） 
Brand name : Pulmicort Respules 0.5mg
　Active ingredient: Budesonide
　Dosage form: white to slightly yellowish white, inhaler, ampuled suspension liquid
　Print on wrapping: パルミコート吸入液0.5mg
Effects of this medicine
This medicine is inhaled steroid used to prevent asthma attack by controlling airway inflammation.
Normally used for bronchial asthma treatment.
This medicine is not for relieving asthma attack that has already occurred.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you have infections, deep mycosis or tuberculosis which are not controllable by any antibacterial drugs.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•General dosage regimen: Use a neblizer to inhale.
For adults, take 2 ampules (0.5mg of the active ingredient) at a time, 2 times a day; or, take 4 ampules once a day. It should be adjusted according to the patient’s condition; however, daily dosage should not exceed 8 ampules (2mg of the active ingredient).
For infants/children (ages 6 months old to below 15 years old), take 1 ampule (0.25mg of the active ingredient) at a time, 2 times a day; or, take 2 ampules once a day. It should be adjusted according to the patient's condition; however, daily dosage should not exceed 4 ampules (1mg of the active ingredient).
Strictly follow the instructions of your doctor/pharmacist.
Read carefully, the instruction leaflet,“To Patients/Guardians Using Pulmicort Respules.”
This medicine is to be inhaled via a jet nebulizer. Nebulizer’s instruction and specification vary depending on the model. Consult your doctor/pharmacist and learn how to use before dosing
Gently swing the ample, no bubble, to stir the suspension before use.
Do not mix with other solutions unless otherwise instructed by your doctor. If you need to mix the solution with something else, check with your doctor/pharmacist beforehand.
After inhaling, gargle or rinse your mouth (if it is difficult, take some fluid) and wash the face with water.
Discard any remaining liquid in the ampule/nebulizer, do not use it.
DO NOT swallow/get this medicine into eyes.
•If you are ordered to use this medicine on regular schedule and you missed a dose, inhale dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT inhale a double dose to make up for the missed dose.
•If you have taken or believe you may have taken excessive Pulmicort Inhalant Liquid 0.25mg, check with your doctor/pharmacist immediately.
•If asthmatic condition changes during the treatment course, check with your doctor. DO NOT reduce or stop inhalation without the instructions of your doctor even if the asthmatic symptoms are gone and you feel well.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
Adults: sore/irritated throat.
Infants/children: Restlessness due to overactive motor nerve, oral Candidiasis, sore/irritated throat, chilitis, canker sores, dermatitis.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of reach of children. Store away from light, heat, humidity and not to be frozen.
•Unused ampules must be kept inside the aluminum bag, away from direct sunlight, heat and humidity and not to be frozen (expiration duration for use is 2 months after opening the aluminum bag).
•After the treatment is over, discard any remaining medicine/amples, do not store them.
AstraZeneca K.KExternal
Revised: 11/2010
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.