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 详细处方信息以本药内容附件PDF文件（20118323121129.pdf）的“原文Priscribing Information”为准
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部分中文西拉普利处方资料（仅供参考）

分类名称
 一级分类：循环系统药物 二级分类：心血管扩张药物 三级分类：血管紧张素转换酶抑制药 
 
药品英文名
Cilazapril
 
药品别名
平苏、抑平舒、一平苏、Inhibace、Inibace、Vascace
 
药物剂型
片剂：2.5mg。
 
药理作用
本品是一种新型长效无巯基血管紧张素转换酶(ACE)抑制药。它本身是一个含羧基的前体药，口服后被组织中酯酶转化成滑出代谢物西拉普利拉。后者是一个竞争性ACE抑制药，对血浆和组织ACE的抑制作用较强，具有较高的选择性和特异性。ACE抑制药能抑制血管紧张素Ⅰ转换为血管紧张素Ⅱ，使醛固酮分泌减少，血浆肾素活性增高，从而使血管阻力降低，血压下降。西拉普利拉还能抑制缓激肽的降解，使血管阻力降低，从而有效降低卧位和立位血压。本药在降压时不引起反射性心动过速。长期给药时其降压作用可维持，突然停药不会引起血压迅速上升。西拉普利能扩张动脉和静脉，降低周围血管阻力(后负荷)及肺毛细血管楔压(前负荷)，从而改善心排血量，提高患者的运动耐量，因而也用于心力衰竭的治疗。
 
药动学
口服吸收完全。给药后2h达到峰值浓度，在体内代谢为有活性的双酸代谢物(cilazaprilat)，代谢物80%～90%由尿排出。消除曲线呈双相，第一相半衰期为1.5h，第二相半衰期为50h。
 
适应证
1.原发性高血压和肾性高血压，可单独应用或与其他降压药如利尿药合用。
2.心力衰竭，可单独应用或与强心药、利尿药同用。
 
禁忌证
1.血管神经性水肿，包括：(1)使用其他血管紧张素转换酶(ACE)抑制药曾引起血管神经性水肿；(2)遗传性血管性水肿；(3)特发性血管性水肿。
2.对本药或其他血管紧张素转换酶抑制药过敏。
3.儿童、孕妇及哺乳期妇女。
4.孤立肾、移植肾、双侧肾动脉狭窄伴肾功能减退者。
5.腹水患者。
 
注意事项
1.慎用：(1)多种原因引起的粒细胞减少，如中性粒细胞减少症，发热性疾病、骨髓抑制、使用免疫抑制药治疗、自身免疫性疾病如胶原性血管病、系统性红斑狼疮等引起者。(2)高钾血症。(3)脑或冠状动脉供血不足，血压降低可加重缺血，血压如大幅下降可引起心肌梗死或脑血管意外。(4)肾功能障碍，可致血钾增高，白细胞减少，并使本药潴留。(5)低血压，严重心力衰竭、血容量不足、缺钠的患者，应用本药可能突然出现严重低血压与肾功能恶化。(6)肝功能障碍。(7)严格饮食限制钠盐或进行透析治疗者，首剂可能出现突然而严重的低血压。(8)在进行膜翅目昆虫脱敏时可出现过敏。(9)主动脉瓣狭窄或肥厚性心肌病。(10)咳嗽。(11)外科手术/麻醉。
2.药物对检验值或诊断的影响：(1)血尿素氮、肌酐浓度增高，常为暂时性，在有肾病或严重高血压而血压迅速下降时易出现。(2)偶有血清肝酶增高。(3)血钾轻度增高，尤其在有肾功能障碍者。
3.用药前后及用药时应当检查或监测：(1)用药前应检测血压，血电解质(血钠、血钾，总二氧化碳)、血尿素氮和肌酐，并定期复查。(2)肾功能障碍或白细胞缺乏的患者在最初3个月内应每2周检查白细胞计数及分类计数1次，此后定期复查。(3)尿蛋白检查，每月1次。
4.用血管紧张素转换酶抑制药治疗的患者，在采用高通透性膜(聚丙烯腈)进行血液透析时，曾发生低血压反应，应避免联合应用。
5.食物对本药吸收的影响不大，故可在饭前或饭后服用，注意每天应在同一时间服用。
6.给药剂量须遵循个体化原则，按疗效予以调整。
7.对以往使用利尿药治疗的患者，在开始本药治疗前停用利尿药2～3天，如有必要以后再加用利尿药。对不能停用者，如严重或恶性高血压，应减少本药剂量，在观察下小心增量。
8.已用强心苷与利尿药的心力衰竭患者如有水、钠缺失时，开始用本药时应采用小剂量。
9.发生血管性水肿时应停用本药，并皮下注射肾上腺素，静脉注射氢化可的松或地塞米松。
10.老年患者开始宜用小剂量，或根据肾功能调整。
11.本药过量时可发生低血压，应予扩容纠正，必要时作透析治疗。
 
不良反应
本品耐受性好，大多数不良反应轻微且短暂，不需要停药。较常见的不良反应有：头痛、眩晕、疲乏、嗜睡、恶心、咳嗽。最常见的停药原因为头痛和咳嗽。少见的不良反应有：症状性低血压、直立性低血压、晕厥、心悸、周围性水肿、皮疹、皮炎、便秘、胃炎、焦虑、失眠、感觉异常、关节痛、肌痛、哮喘等。血管神经性水肿罕见，如出现即应停药。
 
用法用量
原发性高血压，开始每天2.5～5mg，酌情2～4周调整剂量，一般最大剂量每天5mg。肾性高血压、充血性心衰的老年患者或合用利尿剂的患者，初始剂量应从0.5mg开始。根据个体情况进行调整。
 
药物相应作用
1.与其他降压药同用时降压作用加强，其中与引起肾素释放或影响交感活性的药物同用呈大于相加的作用，与β-受体阻滞药同用不会加强其降压效应。
2.与利尿药同用降压作用增大，可引起严重低血压。在开始本药治疗前原利尿药应停用或减量，本药开始剂量宜小，以后再根据血压情况逐渐调整。
3.与其他扩血管药同用可能致低血压，如拟合用，应从小剂量开始。
4.与钾盐，潴钾利尿药如螺内酯、氨苯蝶啶、阿米洛利同用可能引起血钾过高。
5.卡托普利与布比卡因合用，由于对肾素-血管紧张素系统的抑制，可引起严重心动过缓和低血压，甚至意识丧失。本药如与布比卡因合用，也应严密监测。
6.其他ACE抑制药如卡托普利与别嘌醇同用可引起超敏反应。使用本药时也应注意。
7.硫唑嘌呤与ACE抑制药合用可加重骨髓抑制。
8.与环孢素合用可使肾功能下降。
9.非甾体类抗炎药尤其吲哚美辛可抑制肾前列腺素合成，引起水、钠潴留，从而减弱本药的降压效果。阿司匹林使用抗炎剂量(1～2g)时也可明显降低本药的降压作用，同用时应注意。
10.麻黄含麻黄碱和伪麻黄碱，可降低抗高血压药的疗效。使用本药治疗的高血压患者应避免使用含麻黄制剂。
11.本药与普奈洛尔无明显相互作用。

Vascace (cilazapril)
Main use：High blood pressure, heart failure
Active ingredient：Cilazapril monohydrate
Manufacturer：Roche
   
How does it work?
Vascace tablets contain the active ingredient cilazapril, which is a type of medicine called an ACE inhibitor.

ACE inhibitors work by blocking the action of a compound in the body called angiotensin converting enzyme (ACE). Normally ACE produces another compound called angiotensin II, as part of the body's natural control of blood pressure. Angiotensin II causes blood vessels to constrict and narrow, which increases the pressure within the blood vessels.

As cilazapril blocks the action of ACE, it reduces the production of angiotensin II. This means that the blood vessels are allowed to relax and widen. The overall effect of this is a drop in blood pressure, hence cilazapril can be used to lower high blood pressure.

The reduced pressure within the blood vessels means that the heart doesn't have to work as hard to pump the blood around the body. This means that ACE inhibitors such as cilazapril can also be used to improve the symptoms of heart failure, where the heart is not pumping as efficiently as it should be.

What is it used for?
High blood pressure with no known cause (essential hypertension).
Heart failure.

Warning!
Some people may experience dizziness caused by low blood pressure in the first few days of taking this medicine and in particular the first dose. For this reason, the first dose should preferably be taken at bedtime. Your doctor may want you to take the first dose of this medicine under medical supervision in hospital if you are aged over 70 years, have low blood pressure, low levels of fluids or salt in your blood (eg due to dehydration), severe or unstable heart failure, kidney problems, or are taking high doses of diuretic medicines, multiple diuretic medicines, or certain other medicines that dilate your blood vessels.
If you feel dizzy during treatment this can be relieved by lying down until the symptoms pass. If affected you should avoid performing potentially hazardous tasks such as driving or operating machinary. If you frequently feel dizzy you should let your doctor know, as your dose of this medicine may need reducing.
Alcohol may enhance the blood pressure lowering effect of this medicine, which can increase dizziness and may increase the risk of fainting.
ACE inhibitors can sometimes cause an allergic reaction called angioedema. Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue, throat, hands, feet or ankles while taking this medicine. This type of allergic reaction has been reported more frequently in people of Afro-Caribbean origin.
Your blood pressure, kidney function and the amount of potassium in your blood should be regularly monitored while you are taking this medicine.

Use with caution in
Elderly people.
Decreased liver function.
Decreased kidney function.
Narrowing of the arteries that supply blood to the kidneys (renal artery stenosis).
People with hardening of the arteries (athersclerosis), eg in the heart (cardiovascular disease), brain (cerebrovascular disease) or legs (peripheral vascular disease).
People with low fluid volume or salt levels in the body, eg due to diuretic therapy, low-sodium diet, diarrhoea or vomiting.
People taking other medicines for high blood pressure, particularly diuretics (see end of factsheet).
Narrowing of the main artery of the body (aortic stenosis).
Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
Severe heart failure.
Diabetes.
Diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus or rheumatoid arthritis (collagen vascular diseases).
People with kidney failure requiring a certain type of haemodialysis (high-flux membrane).
People receiving therapy to remove certain types of fat from the blood using a machine (LDL apheresis).
People undergoing therapy to decrease allergy to bee or wasp stings (desensitisation).

Not to be used in
Allergy to other ACE inhibitor medicines.
History of swelling of the lips, face or tongue (angioedema) caused by previous use of an ACE inhibitor medicine.
People with fluid accumulation in the abdomen (ascites).
Pregnancy.
Breastfeeding.
Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Vascace tablets contain lactose).
This medicine is not recommended for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used during pregnancy as it may be harmful to the developing baby. Seek further medical advice from your doctor. If you get pregnant while taking this medicine, stop taking it and consult your doctor immediately.

It is not known if this medicine passes into breast milk. The manufacturer states that it should not be taken by women who are breastfeeding. Seek further medical advice from your doctor.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Headache.
Dizziness.
Dry cough.
Fatigue.
Low blood pressure (hypotension).
Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
Rash.
Alteration in taste.
Increased heart rate (tachcardia).
Awareness of your heart beat (palpitations).
Chest pain.
Increased sensitivity of the skin the sunlight (photosensitivity).
Hair loss.
Shortness of breath.
Inflammation of the sinuses or lining of the nose (sinusitis/rhinitis).
Inflammation of the pancreas (pancreatitis).
Severe swelling of lips, face, tongue or throat (angioedema - see warning above).
Problems with kidney function.
Disturbances in the normal levels of blood cells in the blood (tell you doctor if you get a sore throat, mouth ulcers, high temperature (fever), or feel tired or generally unwell while taking this medicine).
Problems with liver function, including jaundice or hepatitis (consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Cilazapril has an additive effect with other medicines that decrease blood pressure, particularly other medicines used to treat high blood pressure (antihypertensives). In people taking antihypertensive medicines it may cause a large drop in blood pressure with the first dose, particularly in people taking diuretic medicines such as furosemide. This may cause dizziness, which can usually be relieved by lying down until the symptoms pass. If you are taking a diuretic medicine, your doctor may reduce your dose or ask you to stop taking it for a few days before starting cilazapril. This is to prevent your blood pressure from dropping too low. If you frequently feel dizzy while taking this medicine in combination with other blood pressure lowering medicines you should let your doctor know, as your doses may need adjusting. Other medicines that decrease blood pressure include the following:
other ACE inhibitors, eg captopril
aldesleukin
alpha-blockers such as prazosin
alprostadil
angiotensin II receptor antagonists such as losartan
antipsychotics
benzodiazepines, eg temazepam, diazepam
baclofen
beta-blockers such as propranolol
calcium-channel blockers such as verapamil, nifedipine
clonidine
diazoxide
diuretics, eg furosemide, bendroflumethiazide
dopamine agonists, eg bromocriptine, apomorphine
hydralazine
levodopa
MAOI antidepressants, eg phenelzine
methyldopa
minoxidil
moxonidine
moxisylyte
nicorandil
nitrates, eg glyceryl trinitrate
tizanidine.

Non-steroidal anti-inflammatory drugs (NSAIDs, eg indometacin, aspirin, diclofenac, ibuprofen) may reduce the blood pressure lowering effect of cilazapril, and may increase the risk of a decline in kidney function. You should avoid taking this type of painkiller unless recommended by your doctor.

There may be a risk of raised potassium levels in the blood (hyperkalaemia) if any of the following medicines are taken with cilazapril, hence these are not normally recommended for use in combination with cilazapril. If you are taking any of the following with this medicine you should have regular blood tests to monitor the amount of potassium in your blood:
angiotensin II receptor antagonists, eg losartan
ciclosporin
drospirenone
epoetin (this may also oppose the blood pressure lowering effect of enalapril)
heparin
potassium-containing salt substitutes (eg Lo-Salt)
potassium salts, eg potassium citrate for cystitis
potassium-sparing diuretics (eg spironolactone, triamterene, amiloride)
potassium supplements.
Cilazapril may increase the blood level of the medicine lithium and for this reason, it is not normally recommended for people taking lithium. People taking this medicine in combination with lithium should have the level of lithium in their blood closely monitored.

Cilazapril may possibly enhance the blood sugar lowering effect of insulin and oral antidiabetic medicines, and so could increase the risk of low blood sugar (hypoglycaemia). People with diabetes should therefore carefully monitor their blood sugar while taking this medicine, particularly in the first few weeks of treatment.

There may be an increased risk of a drop in the normal numbers of white blood cells in the blood if this medicine is taken in combination with any of the following medicines:
allopurinol
azathioprine
immunosuppressant therapy
procainamide.

If you are taking any of these in combination with this medicine, you should have regular blood tests to monitor the levels of your blood cells in your blood, particularly if you also have any kidney problems or diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus or rheumatoid arthritis (collagen vascular diseases). Tell your doctor if you experience any signs of infection, such as fever, sore throat or mouth ulcers, as these could be signs of problems with your white blood cells.

Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain cilazapril as the active ingredient.

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 详细处方信息以本药内容附件PDF文件（20118323121129.pdf）的“原文Priscribing Information”为准
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