部份中文异山梨醇二硝酸酯 处方资料（仅供参考）
英文名：Isosorbide Mononitrate
商品名：Nitorol Spray 
中文名：异山梨醇二硝酸酯 喷雾剂
生产商：卫材
药品简介
Nitorol Spray（Isosorbide Dinitrate）是一种具有血管扩张活性的有机硝，具有血管扩张活性的有机硝酸盐。为预防和治疗冠心病引起的心绞痛发作。
ニトロールスプレー1.25mg
药物类别名称
心绞痛发作缓解的口腔内喷雾
批准日期：2008年６月
商標名
Nitorol
一 般 名
硝酸イソソルビド（Isosorbide Dinitrate)
化 学 名
1, 4：3, 6‐Dianhydro‐D‐glucitol dinitrate
分 子 式
C6H8N2O8
分 子 量
236.14
構 造 式
物理化学的性状
硝酸异二苯二酯是一种白色晶体或结晶粉末,没有异味,或有微闻像硝酸。
本产品n,极可溶于N-二甲基甲酰或丙酮,易溶于氯仿或甲苯、甲醇、乙醇(95)或微溶于二乙醚,几乎不溶于水。
本产品在快速加热或产生冲击时爆炸。
药用药理学
1. 减少预载荷和后载荷
在与麻醉狗的实验中,药物通过延长静脉容量血管,导致静脉反流减少,肺动脉楔形压力和左心室膨胀端压降低(减少预载荷)。通过同时延伸外周动脉,降低整体外周血管阻力(减少后负荷)。这些行动减少了心肌的氧气需求。
2. 冠状血管扩张
在麻醉狗的实验中,该药物延伸了相对厚的冠状动脉(导电血管),减少冠状血管阻力,延长侧继发性血液循环。 虽然冠状动脉血流量增加幅度较小,但缺血性心肌,特别是随着血流量供给的再分配,到心内膜下心肌,增加心肌的氧供应。
3. CGMP生产
与KCl预,将药物添加到收缩小腿的切除冠状动脉中,cGMP的产生与冠状动脉的松弛作用成比例增加。
适应症
缓解心绞痛发作
用法与用量
通常,成人,一旦一次喷雾(1.25毫克)被注射到口腔。
在效果不足的情况下,只要一次喷雾就添加。
用途和剂量说明
(使用)
为了充分获得此代理的效果,正确使用它非常重要。
(1)取下保护盖,按右图所示保持容器支架,用力按压喷雾塞吹气(通常为2-3次),以确认药物正常喷剂。
(2) 每隔3天或以上使用时,吹空后喷。
(3) 将喷口距离口腔靠近2厘米。
张开嘴屏住呼吸时,用力按压喷雾塞,将其喷入嘴里,并立即合上嘴。
此时不要深吸。
(请医生和药剂师)
请务必向患者提供患者说明(对于使用硝基喷雾剂 1.25mg的患者)。
临床表现
1. 临床效果
在双盲试验和心绞痛患者一般临床试验中,该药物的有效率为66.4%(91/137例)。在血液动力学研究中,当该剂在1分钟内出现肺动脉压力的变化时,在同索比德片剂亚语言中硝酸盐需要4分钟。在双盲试验中,与异种片剂亚语言分量硝酸盐相比,该剂在异种硝酸片剂中表现优异。
2. 缓解心绞痛发作的时间
由于批准时进行的临床试验和商业后使用结果,在大多数情况下,在药物服用后五分钟内观察到癫痫发作的缓解。
包装
喷雾 1.25mg (10g: 约 100 倍): 5罐
制造和销售
卫材株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
http://www.info.pmda.go.jp/go/pack/2171700R1034_1_03/
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Nitorol Spray（Isosorbide dinitrate）
Nitorol Spray 1.25mg（ニトロールスプレー1.25mg） 
Brand name : Nitorol Spray 1.25mg
　Active ingredient: Isosorbide dinitrate
　Dosage form: spray
　Print on wrapping: ニトロールスプレー1.25mg, １ｇ中硝酸イソソルビド16.35ｍｇ含有, 100回用
Effects of this medicine
This medicine dilates the venous and peripheral vascular systems to reduce the work load of the heart and dilates the coronary arteries to increase the oxygen supply to the heart, alleviating oxygen shortage in the heart promptly. It relieves the symptoms such as feeling of tightness in the chest or sharp chest pain due to cardiac ischemia.
It is usually used for treatment of ischemic heart disease such as angina or myocardial infarction.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reaction(itch, rash, etc.) to any medicine.
If you have hypotension, cardiogenic shock, glaucoma, anemia, head trauma, brain hemorrhage, pulmonary hypertension or cardiomyopathy.
If you are taking sildenafil citrate (Viagra, Revatio), vardenafil hydrochloride hydrate (Levitra), tadalafil (Cialis, Zalutia, Adcirca) or riociguat (Adempas).
•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>>
•In general, for adults, take 1 to 2 tablets (5 to 10 mg as the active ingredient) at a time, 3 to 4 times a day orally or sublingually, to be adjusted depending on the disease, symptom severity or age. Strictly follow the instructions.
During angina attack: In general, for adults, take 1 to 2 tablets (5 to 10 mg as the active ingredient) at a time sublingually, to be adjusted depending on symptom severity or age. Strictly follow the instructions.
•If you miss a dose, take a dose as soon as possible if you remember that you missed a dose 6 hours or over before the next dose. If it is 6 hours or less before the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•This medicine may cause attention deficit or loss of concentration/reflexes. Avoid operating a motor vehicle or machinery.
•Use caution when consuming alcoholic beverages, since consuming too much alcohol while on this medication may cause headache, dizziness or dizziness on standing up.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, headache and dizziness. If any of these symptoms occur, consult with your doctor or pharmacist.
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 this medicine out of the reach of children and away from direct sunlight, heat or moisture.
•If you have leftover medicines, dispose of them appropriately and do not keep any unused medicine.
Eisai Co., Ltd.External
Revised: 7/2014
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.