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枸橼酸西地那非片REVATIO（SILDENAFIL CITRATE）

2013-03-12 14:55:29 作者：新特药房来源：互联网浏览次数：226 文字大小：【大】【中】【小】

简介： 部分中文瑞肺得处方信息（仅供参考）Revatio DescriptionThis form of Sildenafil is used to treat high blood pressure in the lungs (pulmonary arterial hypertension) by blocking a certain enzy ...

关键字：枸橼酸西地那非片瑞肺得 REVATIO

部分中文瑞肺得处方信息（仅供参考）
Revatio Description
This form of Sildenafil is used to treat high blood pressure in the lungs (pulmonary arterial hypertension) by blocking a certain enzyme (phosphodiesterase-PDE5) in the body. Sildenafil works by relaxing the blood vessels in the lungs and the rest of the body.
Decreasing blood pressure in the lungs allows the heart and lungs to work better and improves your ability to exercise.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Sildenafil is also available in other strengths for treating erectile dysfunction in men. Do not substitute one form of this drug for the other.
Revatio Directions
Read the Patient Information Leaflet provided by your pharmacist before you start taking sildenafil and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
To treat high blood pressure in the lungs, take this medication by mouth as directed by your doctor, usually 3 times a day (about 4-6 hours apart) with or without food.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.
The dosage is based on your medical condition and response to treatment. Consult your doctor or pharmacist for more details.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.
Tell your doctor if your condition does not improve or if it worsens.
Revatio Cautions
Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, high or low blood pressure, a severe loss of body water (dehydration), history of painful/prolonged erection (priapism), eye problems (such as decreased vision in one or both eyes, retinitis pigmentosa), heart problems (such as heart attack or irregular heartbeat in the past 6 months, heart failure, chest pain/angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), kidney disease, liver disease, fluid in the lungs (pulmonary edema), problem with shape of penis (such as angulation, fibrosis/scarring, Peyronie's disease), stroke in the past 6 months.
This drug may make you dizzy or cause vision problems. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, sildenafil should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Revatio Side Effects
Dizziness, lightheadedness, headache, flushing, heartburn, nosebleeds, trouble sleeping, or swollen hands/ankles/feet (edema) may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rarely, a sudden loss of eyesight in one or both eyes (NAION) may occur. This may or may not be due to sildenafil. Get medical help right away if this occurs. You have a slightly greater chance of developing this serious eye problem if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), or high blood pressure, or if you smoke or are over 50.
For males, in the unlikely event you have a painful or prolonged erection lasting 4 or more hours, get medical help right away or permanent problems could occur.
Rarely, sildenafil may cause sudden hearing problems (such as decrease/loss of hearing in one or both ears, ringing in the ears). Get medical help right away if these effects occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Revatio Active Ingredients
Sildenafil

药物成分：西地那非
药理作用：
西地那非是一种环状单磷酸鸟苷(cGMP)特异性第五型磷酸二酯酶(phospho-diesterase type 5, PDE5)的选择性抑制剂。PDE5负责分解细胞内的cGMP。西地那非可抑制PDE5，增加肺血管平滑肌细胞内的cGMP，促使血管扩张。
药物动力学：
口服吸收迅速，但经胃肠黏膜与肝脏代谢，绝对生体可用率约40％。在空腹状态下服药，可于30至120分钟(中位数60分钟)内到达最大血中浓度。当与高脂饮食并服，吸收速率减慢，但吸收总量不变。体内分布很广，稳定状态之分布体积为105公升。血浆蛋白结合率约96％。主要经由肝脏酵素CYP3A4和CYP2C9代谢；其主要代谢物对磷酸二酯酶的选择性与西地那非类似，约20％的药理作用来自于此代谢物。主要以代谢物形式经粪便排除(约为口服剂量的80％)，少部份由尿液排除(约为口服剂量的13％)。排除半衰期约4小时。
适应症：
治疗肺动脉高血压，改善运动能力。
不良反应：
常见的不良反应包括头痛、潮红、鼻塞、失眠、晕眩、眼睛周围疼痛、消化不良、腹泻、皮疹、肌肉疼痛、视觉异常。视觉异常一般是视觉发生轻微而短暂的变色，对光敏感度增加或视力模糊。
注意事项
1.Sildenafil用于有下列患者应特别谨慎：
(1)最近6个月内发生心肌梗塞、中风或危及生命心律不整的患者。
(2)发生不稳定型心绞痛之冠状动脉疾病患者。
(3)严重高血压 (BP>170/110mmHg)或低血压(BP<90/50mmHg) 患者。
(4)肺静脉阻塞性疾病(PVOD)患者。
(5)阴茎构造畸形(如阴茎弯曲、海绵体纤维变性或Peyronie氏病)或容易引起阴茎异发性骨髓瘤或白血病) 患者。若发现阴茎持续勃起超过4小时，需立即寻求医疗协助，以免造成组织伤害，丧失勃起能力。
(6)色素性视网膜炎患者。
(7)出血性疾病或活动性消化性溃疡患者。
2.Sildenafil与α阻断剂并用时须小心，可能会对血压下降产生加成效应。
3.在结缔组织继发的肺动脉高血压患者中，使用sildenafil发生鼻出血机率高于原发性肺动脉高血压患者。
4.合并使用口服维生素K拮抗剂的患者，发生鼻出血的机率较高。
5.服药期间若出现单眼或双眼视力减退，应立即就医。
禁忌
1.正在使用任何剂型的有机硝酸盐患者(无论常规或间歇性服用)。
2.对药品成份过敏者。
3.同时服用蛋白酶抑制剂ritonavir(强效之CYP-3A4 抑制剂)，会使sildenafil血清浓度大幅升高，故不建议并用。
交互作用
西地那非主要由肝脏酵素CYP3A4和CYP2C9代谢，因此，这类酵素抑制剂(如：itraconazole、ketoconazole、cimetidine、saquinavir、ritonavir…)会减少sildenafil的清除，而酵素诱导剂(如：rifampin、carbamazepine、phenytoin、 bosentan…)则会增加sildenafil的清除。
剂量及用法
1.若有特殊情况的病人（如肝肾功能不全、老年人等）需详细说明，密切监测药物的副作用和毒性。注射剂需详细说明给药方法及输注时间。
2.建议剂量：每日三次，每次服用20毫克。每次给药需间隔4到6小时，随餐或空腹服用皆可。肝、肾脏功能不全患者不需调整剂量。

FDA警告：西地那非禁用于肺动脉高压儿童
8月30日，美国食品与药物管理局（FDA）发布安全信息称，不推荐Revatio（有效成分：西地那非) 用于年龄在1~17岁的患肺动脉高压（PAH）儿童。
该推荐是基于一项儿科长期临床试验得出的，该试验结果显示，
1、服用大剂量Revatio的儿童比服用小剂量该药的儿童死亡危险高；
2、小剂量Revatio并不改善患者运动功能。Revatio的药物标签也将增加上述相关信息。
FDA表示，Revatio从未获准用于治疗PAH儿童，FDA的警告是针对该药的标签外使用。Revatio是获准用于改善成人运动功能和延缓其PAH临床恶化的药物。目前Revatio药物标签推荐的成人药物剂量为20 mg，每日服用3次。成人长期应用该药对死亡危险关系尚未知。FDA也正要求该药生产厂家（辉瑞制药公司）评估这一效应。
FDA还建议患者在未咨询医务人员情况下勿自行改变服用剂量或停止治疗。
Revatio是通过扩张肺部血管降低血压的用于治疗PAH的磷酸二酯酶—5抑制剂。Revatio具有与治疗男性勃起功能障碍药物万艾可（Viagra）相同的有效成分。同时，FDA不赞成这一安全信息适用于万艾可（Viagra），因为两药的适用人群和推荐剂量均不同。
附件:

20101610274628.pdf

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产地国家: 美国
原产地英文商品名:
REVATIO 20 MG TABLET MINIMUMS APPLY
原产地英文药品名:
SILDENAFIL CITRATE
原产地英文化合物名称:
1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate
中文参考商品译名:
瑞肺得20毫克/片最低适用
中文参考药品译名:
枸橼酸西地那非
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER