| 简介：
部分中文他达拉非处方资料（仅供参考）
英文名：tadalafi
商标名：Adcirca Tablets
中文名：他达拉非片
生产商：礼来公司
アドシルカ錠20mg
药用类别名称
磷酸二酯酶5抑制剂
批准日期：2009年12月
商標名
Adcirca
一般名：
タダラフィル（JAN）
Tadalafil
化学名：
(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione
分子式：
C22H19N3O4
分子量：
389.40
構造式：
性 状：
它是一种白色粉末。
易溶于亚甲基亚硫酸甲酯, 几乎不溶于乙腈, 几乎不溶于乙醇 (99.5), 不易溶于水。
分布系数:
2.89 (1-octanol/ins)
批准条件
由于日本的临床试验病例极为有限, 在制造和销售之后, 直到积累了一定数量的病例数据, 通过对所有病例进行使用等级调查, 掌握使用这种药物的患者的背景信息, 在早期阶段收集有关该制剂安全性和有效性的数据, 并采取必要措施正确使用该制剂。
药用药理学
1. PDE5抑制作用 (体外)
他达拉非是一种选择性 pde5 抑制剂。与pde6和 Pde6 相比, ic 50值分别为约1nm、700倍和14倍的抑制人重组 Pde6 的选择性是其他 pde 亚型的9000倍以上。
2. 对肺动脉高压模型的影响 (体内)
肺动脉高压的抑制作用:
在单色氨酸致肺动脉高压大鼠模型中, 他达拉非对全身血压、肺动脉压无显著影响, 右心室压力明显抑制。
延长寿命的作用:
他达拉非显著提高了单色性肺动脉高压大鼠的生存率。
3. 作用机制 (前活力)
选择性抑制 pde5 是肺血管平滑肌中的一种主要cgmp降解酶, 表达血管松弛反应显著增加肺组织中的 cgmp。
适应症
肺动脉高压
用法与用量
通常情况下, 成人口服40毫克, 每天一次作为他达拉非。
包装
錠剤20mg：60錠PTP（10錠×6）
制造和销售来源
日本礼来有限公司
注：以上中文处方不够完整，使用者以原处方为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/2190030F1029_1_17/
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Important Safety Considerations for ADCIRCA® (tadalafil) tablets
You should discuss all of your medical conditions and all medications with your healthcare provider before starting ADCIRCA
Do not take ADCIRCA if you take any medications that contain nitrates (often used for chest pain), as the combination could cause a sudden, unsafe drop in blood pressure
Do not take ADCIRCA if you are allergic to tadalafil or any other ingredient in ADCIRCA
If you experience chest pain after taking ADCIRCA, contact your healthcare provider
ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor (PDE-5i). PDE-5is can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your healthcare provider before taking ADCIRCA, as these conditions may be affected by the action of ADCIRCA
If you have ever had blockage in the veins of your lungs, known as pulmonary veno-occlusive disease (PVOD), ADCIRCA is not recommended for you
Taking ADCIRCA with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (light-headedness or fainting)
Do not take ADCIRCA if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both ADCIRCA and ritonavir (Norvir®) at the same time, your dose of ADCIRCA will need to be adjusted. Inform your healthcare provider if you have kidney or liver problems before taking ADCIRCA
ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED, impotence) and the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). If you are taking ADCIRCA, do not take Cialis or other PDE-5is
In rare cases, patients reported side effects such as decreased eyesight or loss of vision in one or both eyes (NAION), or sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you experience any of these side effects after taking ADCIRCA, seek medical attention right away
In rare cases, men taking PDE-5is (including tadalafil) for erectile dysfunction reported side effects such as an erection lasting more than four hours. If you experience a prolonged erection, seek medical attention right away
The most common side effects of ADCIRCA are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose |
