英文药名：ALPROSTADIL INJECTION SYRINGE(alprostadil)

中文药名：前列地尔预充注射器

生产厂家：东和制药
治疗类别名称
前列腺素E1製剤
欧文商標名
ALPROSTADIL INJECTION 5μg SYRINGE "TOWA
ALPROSTADIL INJECTION 10μg SYRINGE "TOWA
一般名：アルプロスタジル（Alprostadil）
化学名：7-{(1R,2R,3R)-3-Hydroxy-2-[(1E,3S)-3-hydroxyoct-1-en-1-yl]-5-oxocyclopentyl}heptanoic acid
分子式：C20H34O5
分子量：354.48
構造式：

性　状：
它是一种白色晶体或结晶粉末。乙醇（99.5），或易溶于四氢呋喃和微溶于乙腈中，几乎不溶于水。
熔点：
114〜118℃
药效药理
1.药效学试验
(1) 对血小板聚集的作用
对于前列地尔注10μg的注射器“TOWA”和标准制剂，采用全血的血小板凝集能力测定装置的措施在人全血中的血小板聚集，需要一个胶原浓度以诱导50％的聚集压力作为比较的结果，显示了血小板凝集抑制作用，这两种药物的效果被确定生物等效。
(2) 颈动脉血流和血压的影响
前列地尔注10μg的注射器“TOWA”和标准配方（0.1微克/公斤）从在正常犬右股静脉（1组26只）在麻醉下，最大血流量变化和平均血压在颈总动脉给药你在哪里相比下降的最大量，这两种药物还显示出增加和降血压效果的血流量，分别的动作被判断为生物等效。
(3) 外周血流量和血压的影响
前列地尔注10μg的注射器“TOWA”和标准配方（3微克/公斤）从尾静脉施用菌素（STZ）诱导的糖尿病大鼠（第1组15只动物），下后腿足垫的最大血流量变化和平均血压的最大下降量进行比较研究的结果，这两种药物还显示出增加和降血压效果的血流量的作用的，分别被判断为生物等效。
2. 作用机序
它作用于前列腺素类受体在血管平滑肌，改善外周循环障碍表明通过增加细胞内cAMP一个血管扩张活性。此外，它还具有血小板聚集抑制作用。
适应症
改善慢性动脉闭塞症（血栓闭塞性脉管炎，动脉硬化闭塞症）肢体溃疡和疼痛在休息
而改善皮肤溃疡的以下疾病
进行性全身性硬化症
系统性红斑狼疮
改进皮肤溃疡糖尿病
改进与末梢血液循环障碍振动病以及外周循环的恢复及神经运动功能障碍相关的主观症状
在动脉导管未闭，动脉导管未闭，先天性依赖心脏疾病的通畅
用法用量
慢性动脉闭塞性疾病（伯格氏病，闭塞性动脉硬化症），进行性全身性硬化症，全身性红斑狼疮，糖尿病，振动病的情况下
普通，成人每天一次1〜2毫升的静脉（5〜10微克的前列地尔），慢慢地通过直接混合或滴注，或静脉滴注。此外，将根据症状调整。
- 在动脉导管依赖型先天性心脏疾病的情况下，
混合输液指连续静脉作为起始前列地尔5NG/千克/分钟，其后它是一种有效的最小量增加，或适于根据症状减少。
包装规格
注射器：5微克“TOWA”：1毫升×5注射器

注射器：10微克“TOWA”：2毫升×5注射器

生产商：
东和制药有限公司
http://www.info.pmda.go.jp/go/pack/2190406G2070_1_02/
http://www.info.pmda.go.jp/go/pack/2190406G1058_1_02/2190406G1058_1_02?view=body
ALPROSTADIL INJECTION SYRINGE（Alprostadil）
ALPROSTADIL INJECTION 10mcg SYRINGE "TOWA" [arterial duct-dependent congenital heart disease]（アルプロスタジル注10μgシリンジ「トーワ」［動脈管依存性先天性心疾患］） 
Brand name : ALPROSTADIL INJECTION 10mcg SYRINGE "TOWA" [arterial duct-dependent congenital heart disease]
　Active ingredient: Alprostadil
　Dosage form: injection
　Print on wrapping: 
ALPROSTADIL INJECTION 10mcg SYRINGE "TOWA" [chronic arterial obstruction, progressive systemic sclerosis, systemic erythematosus, diabetes mellitus, vibration disease]（アルプロスタジル注10μgシリンジ「トーワ」［慢性動脈閉塞症、進行性全身性硬化症、全身性エリテマトーデス、糖尿病、振動病］） 
Brand name : ALPROSTADIL INJECTION 10mcg SYRINGE "TOWA" [chronic arterial obstruction, progressive systemic sclerosis, systemic erythematosus, diabetes mellitus, vibration disease]
　Active ingredient: Alprostadil
　Dosage form: injection
　Print on wrapping: 
ALPROSTADIL INJECTION 5mcg SYRINGE "TOWA" [arterial duct-dependent congenital heart disease]（アルプロスタジル注5μgシリンジ「トーワ」［動脈管依存性先天性心疾患］）
Brand name : ALPROSTADIL INJECTION 5mcg SYRINGE "TOWA" [arterial duct-dependent congenital heart disease]
　Active ingredient: Alprostadil
　Dosage form: injection
　Print on wrapping: 
ALPROSTADIL INJECTION 5mcg SYRINGE "TOWA" [chronic arterial obstruction, progressive systemic sclerosis, systemic erythematosus, diabetes mellitus, vibration disease]（アルプロスタジル注5μgシリンジ「トーワ」［慢性動脈閉塞症、進行性全身性硬化症、全身性エリテマトーデス、糖尿病、振動病］） 
Brand name : ALPROSTADIL INJECTION 5mcg SYRINGE "TOWA" [chronic arterial obstruction, progressive systemic sclerosis, systemic erythematosus, diabetes mellitus, vibration disease]
　Active ingredient: Alprostadil
　Dosage form: injection
　Print on wrapping: 
ALPROSTADIL INJECTION 5mcg SYRINGE "TOWA" [superior mesenteric arterial portography]（アルプロスタジル注5μgシリンジ「トーワ」［経上腸間膜動脈性門脈造影］）
Brand name : ALPROSTADIL INJECTION 5mcg SYRINGE "TOWA" [superior mesenteric arterial portography]
　Active ingredient: Alprostadil
　Dosage form: injection
　Print on wrapping: 
Effects of this medicine
This medicine dilates the vessel to intensify the effect of contrast dye during portography.
It is usually used to improve imaging ability on superior mesenteric arterial portography.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have heart disease, bleeding (black stool, vomiting of blood), glaucoma, elevated eye pressure, interstitial pneumonia, renal disease, bleeding tendency, esophageal varices.
If you have stomach ulcer or have a history of it.
If you are pregnant, breastfeeding or possibly pregnant.
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, inject into superior mesenteric artery 30 seconds before contrast dye injection.
Precautions while taking this medicin
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nausea, stomachache, vomiting, diarrhea, abdominal bloating/discomfort, blood pressure reduction, vasculitis, hot flush in face, feeling of chest tightness, chest pain, elevated blood pressure, asthma, fever, headache, rash, itch, exacerbation of renal failure (swelling, decreased urine output, headache), vascular pain/redness at the injection site, bleeding (nose/eyeground/conjunctiva/subcutaneous bleeding, bloody urine) or feeling of warmth. 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.
hives, swelling of larynx, respiratory distress [shock, anaphylactoid symptoms]
loss of conciousness [loss of conciousness]
palpitation, chest tightness, respiratory distress [heart failure, pulmonary edema]
fever, dry cough, respiratory distress [interstitial pneumonia]
chest pain, feeling of chest tightness [myocardial infarction]
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.
TOWA PHARMACEUTICAL CO., LTD. Injection
Published: 12/2012
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.