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  药店国别: 德国药房
产地国家: 德国
所属类别: 心血管系统药物->抗高血压药物
处方药:处方药
包装规格: 20片/盒
计价单位:
  点击放大  
生产厂家英文名:
Puren Pharma
该药品相关信息网址1:
https://www.webmd.com/drugs/2/drug-8843/ramipril-oral/details
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Ramipril
原产地英文商品名:
Ramipril Tablet 5mg, 20 Tabs
原产地英文药品名:
ramipril
中文参考商品译名:
雷米普利片 5毫克, 20片
中文参考药品译名:
雷米普利
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Primary hypertension
临床试验期:
完成
中文适应病症参考翻译1:
原發性高血壓
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201883007595139.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文Ramipril处方资料(仅供参考)

雷米普利片 Ramipril tablets

中文别名: 雷米普利片

英文别名: Altace、Delix、Ramace

药品类别: 抗高血压病药

药理药动

雷米普利片2.5mg/片,为淡黄色至黄色带有刻痕的异形片

雷米普利片5mg/片,为粉色带有刻痕的异形片

主要成分及其化学名称:雷米普利

分子式:C23H32N2O5

分子量:416.5

药理毒理:

雷米普利是一个前体药物,从胃肠道吸收后在肝脏水解生成有活性的血管紧张素转化酶(ACE)抑制剂-雷米普利拉,是强效和长时间作用的ACE抑制剂。服用雷米普利会导致血浆肾素活性的升高,和血管紧张素Ⅱ及醛固酮血浆浓度的下降。因为血管紧张素Ⅱ的减少,ACE抑制剂可导致外周血管扩张和血管阻力下降,从而产生有益的血流动力学效应。有证据显示,组织ACE,尤其是血管系统-而不是循环中的ACE,是决定血流动力学效应的主要因素。 同激肽酶Ⅱ一样,血管紧张素转化酶也能降解缓激肽。有证据显示,雷米普利拉引起的ACE抑制,对激肽释放酶-激肽-前列腺素系统能产生某些效应。有人推测这一机制参与了雷米普利的降压和代谢作用。 高血压患者服用雷米普利后导致卧位和立位血压的下降。在服药后的1-2小时内就产生明显的降压效应;峰值效应出现在服药后的3-6小时;已显示治疗剂量的降压效应至少可以维持24小时。 在鼠、兔和猴身上进行的生殖毒理学研究没有发现任何致畸作用。无论雄性还是雌性鼠身上都没有发现对生殖能力的损害。妊娠和哺乳期间的雌鼠,每日给予50mg/kg或更大剂量的雷米普利,会使后代产生不可逆的肾脏损害(肾盂的扩张)。

药代动力学:

雷米普利口服给药后能被迅速地从胃肠道吸收,在1小时之内即可达到血浆峰浓度。其活性代谢产物-雷米普利拉的峰值血浆浓度出现在用药后的2-4小时以内。 雷米普利拉的血浆峰浓度以多相方式下降。如雷米普利5-10mg每日1次给药,经数日后雷米普利拉的有效半衰期是13-17小时;以较低的剂量(雷米普利1.25-2.5mg)给药时,有效半衰期明显延长。这种差异与极低血浆浓度时观察到的雷米普利拉的浓度时间曲线的长终末相有关。这一终末相不依赖于药物剂量,提示同雷米普利拉结合的酶的作用是可饱和的。雷米普利常用剂量,每日1次给药,大约在4天后可达到雷米普利拉的稳态血浆浓度。 雷米普利几乎能被完全地代谢,其代谢产物主要从肾脏排泄(大约60%从尿中排泄,40%从粪便排泄)。除其活性代谢产物-雷米普利拉以外,其它没有活性的代谢产物包括二酮哌嗪酯、二酮哌嗪酸及其耦合物。

适 应 症

-原发性高血压 -急性心肌梗死2-9天后出现的轻到中度心力衰竭(NYHAⅡ和Ⅲ)

用法用量

1.单剂量和每天给药量的剂量学

注意:在雷米普利片治疗初期可能会引起血压过度降低,尤其是患者伴有盐和/或体液流失(如呕吐/腹泻,利尿治疗),心衰-尤其是心肌梗死后-或严重高血压。 如果可能,开始用雷米普利片治疗前,应纠正盐和/或体液流失,减少或停用现正使用的利尿剂(在心衰患者,必须权衡容量负荷过重的风险)。 这些患者的治疗应当以最低单剂量开始,早晨服用1.25mg雷米普利。 首剂后,每当雷米普利片和/或利尿剂剂量增加时,这些病人应给予医疗监护至少8小时,以免发生难以控制的低血压反应。 患有恶性高血压或心衰的患者-尤其是急性心肌梗死后-用雷米普利片治疗时应住院。 除非另有医嘱,以下剂量推荐适用于肾功能正常的患者:

原发性高血压:

起始剂量一般为2.5mg雷米普利片晨服,如果该剂量血压不能恢复正常,可增加至每天5mg。

增加剂量时应该有最小3周的间隔。维持剂量一般为每日2.5~5mg,量大剂量不超过每日10mg。

急性心肌梗死后(2-9)轻中度心衰(NYHAⅡ和Ⅲ)的治疗:

注意:雷米普利片治疗的调节只能在血流动力学稳定的病人住院的情况下进行。 同时服用其它抗高血压药物的患者,必须小心监测,以免发生低血压。 起始每日剂量一般为2.5mg,早晚分服。

如果此起始剂量患者耐受不了(如血压过低),应该降低到1.25mg,早晚分服。

根据患者的情况,剂量可增加。间隔1-2天剂量可加倍,至每日量大剂量5mg雷米普利,早晚分服。 中度肾功能损害患者(肌酐清除率30-60ml/min或血清肌酐浓度>1.2且<1.8mg/dI):老年患者(超过65岁)或糖尿病患者的剂量起始剂量为1.25mg晨服(见起始剂量注意事项),维持量通常为每天2.5mg雷米普利片。每天最大剂量不能超过5mg雷米普利片。

2.给药方法和持续时间

不管什么时候就餐,足量液体吞服即可。依适应症和剂量的不同,指定的每日剂量可在早晨一次完全服用或分成两次(早晚各一次)服用。 加服利尿剂可增强雷米普利片的降压效果。

对急性心肌梗死后出现心衰的患者,不得早于梗死后2日内开始服用雷米普利片,但也不应迟于梗死后10天才开始服用。另外建议给予雷米普利片至少15个月。

不良反应

在使用雷米普利片或其它ACE抑制剂治疗期间,已观察到如下列不良反应:

心血管:

偶尔地,尤其在使用雷米普利片治疗的初始阶段和伴有盐和/或体液流失的患者(如先前的利尿剂治疗)、心衰-尤其是急性心肌梗死后,严重高血压,当雷米普利片和/或利尿剂的剂量增加时,可能会出现血压过度降低(低血压,直立性低血压),伴有头晕、头重脚轻(一些病人注意力丧失)、出汗、虚弱、视觉障碍等症状,罕见意识丧失(晕厥)。 个别病例使用ACE抑制剂发生下列与血压明显下降相关的不良反应:心动过速,心悸,心绞痛,心肌梗死,TIA,脑卒中。可能出现心律失常或者心律失常加重;在用雷米普利片治疗期间,由于血管狭窄引起的循环紊乱可以加重。 肾脏: 偶而可发生肾损害或者肾损害加重,在个别病例导致急性肾功能衰竭。观察发现罕有蛋白尿,有时蛋白尿伴有肾功能恶化。

呼吸道: 有时干咳无痰和支

气管炎,罕见气短、鼻窦炎、鼻炎,个别病例可能发生支气管痉挛、舌炎和口腔干燥。

个别病例ACE抑制剂引起的血管神经性水肿可能进展并累及喉、咽和/或舌。推荐采取下列紧急措施:

立即皮下注射0.3-0.5mg肾上腺素或者在心电图和血压监测下缓慢静脉注射0.1mg肾上腺素,接着糖皮质激素全身给药。 也推荐抗组胺药物和H2受体拮抗剂静脉给药。除肾上腺素外,在已知C1灭活剂(补体C1酯酶抑制剂)缺乏时,可以考虑使用C1灭活剂。

胃肠道/肝脏:

偶尔出现胃肠道副作用,如胃痛、恶心、呕吐、上腹部不适(一些病例胰酶升高)和消化系统紊乱,很少发生呕吐、腹泻、便秘和食欲丧失。 在ACE抑制剂治疗期间,曾有一个综合征的罕见报道,开始时为胆汁郁积型黄疸,接着发展为肝坏死(有时会致命)。该不良反应同用药的关系尚不清楚。 如果出现黄疸或显著的肝酶升高,必须停止用雷米普利片治疗,并将病人置于医疗监护之下。 在用ACE抑制剂治疗期间,个别病例发生肝功能异常、肝炎、胰腺炎和肠梗阻(不全梗阻)。

皮肤,血管:

偶发皮肤过敏反应,如斑丘疹或苔癣疹或皮疹,荨麻疹和瘙痒罕见,可能发生严重的皮肤反应,如多形红斑或累及唇、脸和/或四肢的血管神经性水肿,需要停用雷米普利治疗。也可能发生较轻微的非血管神经性水肿,如踝关节周围。 在使用ACE抑制剂治疗期间,极少见牛皮癣样疹或天疱疮样疹、皮肤对光过敏、面红、结膜刺激、脱发、指甲松离及加重或引起雷诺现象。 个别病例上述皮肤反应可能伴有发热、肌痛、关节痛/关节炎、血管炎、嗜酸性粒细胞增多症和/或抗核抗体滴度增加。 如果怀疑是严重的皮肤反应,立即同医生联系,如果必要,必须中止雷米普利片的治疗。

神经系统:

少见的副作用是头痛和疲劳。罕见的不良反应是困倦和嗜睡、忧郁、睡眠紊乱、软弱无力、性欲下降、感觉异常、平衡失调、神志迷乱、焦虑、神经质、疲乏、颤抖、听力障碍(如耳鸣)、视力模糊和味觉紊乱或者短暂丧失。 血细胞计数的变化,实验室参数: 血红蛋白浓度、红细胞压积、白细胞或血小板计数偶尔可能下降。尤其是肾功能损害,结缔组织病,或同时服用别嘌呤醇、普鲁卡因酰胺或一些抑制免疫反应药物的患者,罕见贫血、血小板减少症、中性粒细胞减少症、嗜酸性粒细胞增多症。个别病例出现粒细胞减少症或全细胞减少症(如引起骨髓抑制的结果)。 有报道个别病例发生同G-6-PDH缺乏相关的溶血/溶血性贫血,尚无证据证明该不良反应同ACE抑制剂有因果关系。 尤其是肾功能损伤的患者,罕见血清尿素氮、肌酐和血钾浓度升高(高钾血症),血钠浓度可能下降。在糖尿病患者已观察到血清钾浓度的升高。 可检出尿蛋白排出量增加。 个别病例可能出现胆红素和肝酶浓度的增加。 注意:在用雷米普利片治疗前和治疗期间,应定期检查上述实验室指标。 建议短期内检查血清电解质、肌酐浓度和血象,尤其是在治疗开始时,以及处于危险中的病人(肾功能损害和结缔组织疾病的患者),或者使用免疫抑制剂、细胞抑制剂、别嘌呤醇、普鲁卡因酰胺治疗的患者。 用雷米普利片治疗期间,如果有发热、淋巴结肿大和/或咽喉疼痛症状,必须立即检查白细胞计数。

注意患者反应:

用此药治疗需要定期医学检查。由于个体反应的差异,一些患者的反应可以发生明显的改变,以至于他们驾车、操作机器或者工作时没有扶手或者安全支点的能力受到损害,在用药初期、增加剂量时或者改变剂型或者同时饮酒时尤其如此。 禁忌症

下列情况不能给予雷米普利:

-对雷米普利或任何其它成份过敏者。

-已知的血管神经性水肿病史(如先前用ACE抑制剂治疗发生血管神经性水肿)。

-肾动脉狭窄(双侧或单肾患者)。

-肾移植后

-血流动力学相关的主动脉或二尖瓣狭窄,或肥厚性心肌病。

-原发性醛固酮增多症。

-妊娠(开始治疗之前必须排除妊娠的可能

性,并采取避孕措施)。

-哺乳(需要断奶)

当雷米普利片用于急性心肌梗死后轻到中度心力衰竭时,有下列额外禁忌症:

-持续的低血压(收缩压低于90mmHg)

-直立性低血压(坐位1分钟后收缩压降低≥20mmHg)

-严重心衰(NYHA Ⅳ)

-不稳定心绞痛

-威胁生命的室性心律失常

-肺原性心脏病

由于缺乏治疗经验,雷米普利片不能用于下列情况:

-严重的肾损害(肌酐清除率<30ml/min)

-透析

-原发性肝脏疾病或肝功能损害

-未经治疗的、失代偿性心力衰竭

-儿童

用雷米普利片治疗期间,不能使用聚丙烯腈或甲基烯丙基硫化钠高通量滤膜(如AN69)透析或血液过滤。

如果急需透析或血液过滤,须先转换成另一类(非AcE抑制剂)抗高血压或者急性心肌梗死后治疗心力衰竭的药物,或者必须使用一种不同的透析膜(见“注意事项”)。 口服ACE抑制剂的患者,在使用硫酸葡聚糖进行LDL(低密度脂蛋白)分离清除时,可能发生威胁生命的过敏样反应。

育龄期妇女在给予雷米普利片之前必须排除妊娠,在使用雷米普利片治疗期间这些妇女必须采取适当的避孕措施。如果在使用雷米普利片治疗期间发生了妊娠,在咨询医生后必须采取对儿童危险较低的其它治疗,这是因为孕期服用雷米普利片,尤其是怀孕的最后6个月,可能导致胎儿损伤。

如果在哺乳期间需要使用雷米普利片治疗,必须停止母乳喂养。

儿童用药:

雷米普利片没有进行儿童用药的研究,因此不推荐用于这一年龄组的患者。

老年患者用药:

在同时使用利尿剂,有充血性心力衰竭或肾功能或肝功能不全的老年人,雷米普利片的使用应该谨慎。应根据血压控制的需要仔细调节剂量。

药物相互作用

与雷米普利片或其它ACE抑制剂联合用药有如下相互作用:

-氯化钠能减弱雷米普利片的降压和缓解心衰症状的效果。

-抗高血压药物(尤其利尿剂)和其它具有潜在降压作用的药物(如硝酸盐、三环类抗抑郁药、麻醉剂)增强雷米普利片的降压效果。

-镇痛药、抗炎药物(如乙酰水杨酸、吲哚美辛)可能减弱雷米普利片的降压效果。

-钾盐、保钾利尿剂(如螺旋内酯、阿米洛利、氨苯蝶啶)和其它可导致血钾浓度升高的药物(如肝素)可显著升高血清钾浓度。

-锂盐可导致血清锂浓度增高(需要定期监测)。

-乙醇提高雷米普利的降压能力,雷米普利加强酒精的效应。

-催眠剂、麻醉药能使降压效果更加明显(用雷米普利治疗应通知麻醉师)

-别嘌呤醇、细胞生长抑制剂、免疫抑制剂、有全身作用的皮质醇类、普鲁卡因酰胺能降低血液白细胞数;白细胞减少症。

-雷米普利能增强口服降糖药(如磺脲类/双胍类)和胰岛素的降糖效果。

Ramipril tablets Ramipril tablets

Chinese alias: Ramipril film

English alias: Altace, Delix, Ramace

 

Drug Category: Antihypertensives

 

Pharmacological action

Ramipril tablets 2.5mg/tablet, light yellow to yellow with scored shaped tablets

Ramipril tablets 5mg/tablet, pink with scored shaped tablets

Main ingredients and their chemical name: Ramipril

Molecular formula: C23H32N2O5

Molecular weight: 416.5

Pharmacology and Toxicology:

Ramipril is a prodrug that is hydrolyzed in the liver after absorption from the gastrointestinal tract to produce an active angiotensin-converting enzyme (ACE) inhibitor, ramipril, which is potent and long-acting ACE inhibition. Agent. Taking ramipril resulted in an increase in plasma renin activity and a decrease in plasma concentrations of angiotensin II and aldosterone. Because of the decrease in angiotensin II, ACE inhibitors can cause peripheral vasodilation and decreased vascular resistance, resulting in beneficial hemodynamic effects. There is evidence that tissue ACE, especially the vascular system - rather than circulating ACE - is a major factor in determining hemodynamic effects. Like kininase II, angiotensin-converting enzymes also degrade bradykinin. There is evidence that ACE inhibition by ramipril has certain effects on the kallikrein-kinin-prostaglandin system. It has been speculated that this mechanism is involved in the antihypertensive and metabolic effects of ramipril. The use of ramipril in patients with hypertension leads to a decrease in blood pressure in the supine and standing positions. A significant antihypertensive effect occurs within 1-2 hours after administration; the peak effect occurs 3-6 hours after administration; the antihypertensive effect of the therapeutic dose has been shown to be maintained for at least 24 hours. Reproductive toxicology studies in rats, rabbits, and monkeys did not reveal any teratogenic effects. No damage to fertility was found in either male or female rats. Female rats during pregnancy and lactation, given a daily dose of 50 mg/kg or more of ramipril, can cause irreversible kidney damage (expansion of the renal pelvis).

Pharmacokinetics:

Ramipril can be rapidly absorbed from the gastrointestinal tract after oral administration, and the peak plasma concentration can be reached within 1 hour. The peak plasma concentration of its active metabolite, ramipril, occurs within 2-4 hours after administration. The plasma peak concentration of remiprilat decreased in a multi-phase manner. If ramipril 5-10mg is administered once a day, the effective half-life of ramipril is 13-17 hours after a few days; when administered at a lower dose (remipril 1.25-2.5mg) The effective half-life is significantly prolonged. This difference is related to the long terminal phase of the concentration time curve of remiprril observed at very low plasma concentrations. This terminal phase is independent of the drug dose, suggesting that the enzyme that binds to ramipril is saturable. The usual dose of ramipril, administered once a day, reaches the steady-state plasma concentration of ramipril after approximately 4 days. Ramipril is almost completely metabolized, and its metabolites are mainly excreted from the kidneys (about 60% excreted from the urine and 40% excreted from the feces). In addition to its active metabolite, remiprril, other inactive metabolites include diketopiperazine, diketopiperic acid and its conjugates.

Adaptation

  - essential hypertension - mild to moderate heart failure 2-9 days after acute myocardial infarction (NYHAII and III)

Usage and Usage

  

1. Dosage of single dose and daily dose

Note: In the early stages of treatment with ramipril tablets, excessive blood pressure may be caused, especially in patients with salt and / or fluid loss (such as vomiting / diarrhea, diuretic treatment), heart failure - especially after myocardial infarction - or severely high blood pressure. If possible, before starting treatment with ramipril tablets, salt and / or fluid loss should be corrected, and the diuretics currently in use should be reduced or discontinued (in patients with heart failure, the risk of excessive capacity overload must be weighed). Treatment for these patients should start with the lowest single dose and 1.25 mg ramipril in the morning. After the first dose, each time the dose of ramipril tablets and/or diuretics increases, these patients should be given medical supervision for at least 8 hours to avoid an uncontrollable hypotensive response. Patients with malignant hypertension or heart failure - especially after acute myocardial infarction - should be hospitalized when treated with ramipril tablets. Unless otherwise prescribed, the following doses are recommended for patients with normal renal function:

Intensive hypertension:

The starting dose is usually 2.5 mg of ramipril tablets. If the blood pressure does not return to normal, it can be increased to 5 mg per day.

There should be a minimum interval of 3 weeks when increasing the dose. The maintenance dose is generally 2.5 to 5 mg per day, and the large dose does not exceed 10 mg per day.

Treatment of mild to moderate heart failure (NYHAII and III) after acute myocardial infarction (2-9):

Note: The regulation of ramipril tablets can only be performed in patients with hemodynamically stable patients. Patients who take other antihypertensive drugs at the same time must be carefully monitored to avoid hypotension. The initial daily dose is usually 2.5 mg, which is divided into morning and evening.

If this initial dose of patients can not tolerate (such as low blood pressure), it should be reduced to 1.25mg, morning and evening.

The dose can be increased depending on the condition of the patient. The dose can be doubled at intervals of 1-2 days, to a daily dose of 5 mg of ramipril, morning and evening. Patients with moderate renal impairment (creatinine clearance 30-60 ml/min or serum creatinine >1.2 and <1.8 mg/dI): The dose starting dose for elderly patients (over 65 years) or diabetic patients is 1.25 mg morning dress ( See starting dose precautions), the maintenance amount is usually 2.5 mg of ramipril tablets per day. The maximum dose per day should not exceed 5 mg of ramipril tablets.

2. Method of administration and duration

Whenever you eat, you can swallow enough liquid. Depending on the indication and dose, the specified daily dose can be taken completely in the morning or divided twice (in the morning and evening). Adding a diuretic can enhance the antihypertensive effect of ramipril tablets.

In patients with heart failure after acute myocardial infarction, ramipril tablets should not be taken as early as 2 days after infarction, but should not be taken 10 days after infarction. It is also recommended to give ramipril tablets for at least 15 months.

Adverse reactions

  During the treatment with ramipril tablets or other ACE inhibitors, adverse reactions such as the following have been observed:

Cardiovascular:

Occasionally, especially in the initial stages of treatment with ramipril tablets and patients with salt and / or fluid loss (such as previous diuretic treatment), heart failure - especially after acute myocardial infarction, severe hypertension, when Increased dose of ramipril tablets and/or diuretics may result in excessive blood pressure reduction (hypotension, orthostatic hypotension), with dizziness, top-heavy (some patients with loss of attention), sweating, weakness, vision Symptoms such as obstacles, rare loss of consciousness (syncope). In some cases, ACE inhibitors have the following adverse effects associated with a significant drop in blood pressure: tachycardia, palpitations, angina pectoris, myocardial infarction, TIA, stroke. Arrhythmias may occur or arrhythmia may worsen; during treatment with ramipril tablets, circulatory disturbances due to stenosis may be aggravated. Kidney: Occasionally, kidney damage or increased kidney damage can occur, leading to acute renal failure in individual cases. Observed rare proteinuria, sometimes proteinuria accompanied by deterioration of renal function.

Respiratory: Sometimes dry cough without phlegm and support

bronchitis, rare shortness of breath, sinusitis, rhinitis, bronchospasm, glossitis and dry mouth may occur in some cases.

Angioedema caused by ACE inhibitors in individual cases may progress and involve the larynx, pharynx and/or tongue. The following emergency measures are recommended:

Immediately subcutaneous injection of 0.3-0.5 mg of epinephrine or slow intravenous injection of 0.1 mg of epinephrine under electrocardiogram and blood pressure monitoring followed by systemic administration of glucocorticoids. Antihistamines and H2 receptor antagonists are also recommended for intravenous administration. In addition to adrenaline, the C1 inactivating agent can be considered when a C1 inactivating agent (complement C1 esterase inhibitor) is known to be deficient.

Gastrointestinal/Liver:

Occasionally gastrointestinal side effects such as stomach pain, nausea, vomiting, upper abdominal discomfort (increased pancreatic enzymes in some cases) and digestive disorders, vomiting, diarrhea, constipation and loss of appetite are rare. During the treatment of ACE inhibitors, there was a rare report of a syndrome that initially started with cholestasis-type jaundice and then developed into liver necrosis (sometimes fatal). The relationship between this adverse reaction and medication is unclear. If jaundice or significant elevation of liver enzymes occurs, treatment with ramipril tablets must be discontinued and the patient placed under medical supervision. During treatment with ACE inhibitors, liver dysfunction, hepatitis, pancreatitis, and intestinal obstruction (incomplete obstruction) occurred in individual cases.

Skin, blood vessel:

Occasional skin allergic reactions such as maculopapular or mossy rash or rash, urticaria and itching are rare, and severe skin reactions such as polymorphous erythema or angioedema involving the lips, face and/or extremities may need to be discontinued. Ramipril treatment. Minor non-angiopathic edema may also occur, such as around the ankle joint. During treatment with ACE inhibitors, psoriasis-like rash or pemphigus-like rash, skin allergies, flushing, conjunctival irritation, hair loss, nail loosening and aggravation or Raynaudation are rare. In some cases, the above skin reactions may be accompanied by an increase in fever, myalgia, arthralgia/arthritis, vasculitis, eosinophilia, and/or antinuclear antibody titers. If you suspect a serious skin reaction, contact your doctor immediately and, if necessary, discontinue treatment with ramipril tablets.

Neural system:

The rare side effects are headache and fatigue. Rare adverse reactions are drowsiness and lethargy, depression, sleep disturbance, weakness, loss of libido, paresthesia, balance disorders, confusion, anxiety, nervousness, fatigue, tremors, hearing impairment (such as tinnitus), blurred vision and dysphoria Or a short loss. Changes in blood cell count, laboratory parameters: Hemoglobin concentration, hematocrit, white blood cell or platelet count may occasionally decrease. Especially in patients with impaired renal function, connective tissue disease, or concurrent allopurinol, procainamide or some immunosuppressive drugs, rare anemia, thrombocytopenia, neutropenia, eosinophilia disease. Individual cases have neutropenia or whole-cell depletion (as a result of myelosuppression). It has been reported that hemolysis/hemolytic anemia associated with G-6-PDH deficiency has occurred in individual cases, and there is no evidence that the adverse reaction has a causal relationship with ACE inhibitors. Especially in patients with impaired renal function, rare serum urea nitrogen, creatinine and serum potassium levels (hyperkalemia), blood sodium concentration may decline. An increase in serum potassium concentration has been observed in diabetic patients. An increase in urine protein excretion can be detected. An increase in bilirubin and liver enzyme concentrations may occur in individual cases. Note: The above laboratory indicators should be checked regularly before and during treatment with ramipril tablets. It is recommended to check serum electrolytes, creatinine concentrations and blood levels in the short term, especially at the beginning of treatment, as well as patients at risk (patients with impaired renal function and connective tissue disease), or with immunosuppressive agents, cytostatics, allopurinol , patients treated with procainamide. White blood cell counts must be checked immediately if there is fever, swollen lymph nodes, and/or sore throat symptoms during treatment with ramipril tablets.

Note patient response:

Treatment with this drug requires regular medical examination. Due to differences in individual responses, some patients' responses can change significantly, so that their ability to drive, operate, or work without armrests or safety points is compromised, at the beginning of the dose, when adding doses, or when changing dosage forms or drinking at the same time. This is especially true. Contraindications  

Ramipril cannot be given in the following cases:

-A person who is allergic to ramipril or any other ingredient.

-A history of known angioedema (eg, angioedema previously treated with an ACE inhibitor).

- Renal artery stenosis (bilateral or single kidney patients).

-After kidney transplantation

-hemodynamically related aortic or mitral stenosis, or hypertrophic cardiomyopathy.

- Primary aldosteronism.

-Pregnant (precaution of pregnancy must be ruled out before starting treatment and contraceptive measures are taken).

-Breastfeeding (need to be weaned)

When ramipril tablets are used for mild to moderate heart failure after acute myocardial infarction, the following additional contraindications apply:

-Continuous hypotension (systolic blood pressure below 90mmHg)

-Orthostatic hypotension (systolic blood pressure decreased by ≥20mmHg after 1 minute of sitting position)

-Severe Heart Failure (NYHA IV)

-Unstable angina

-Life-threatening ventricular arrhythmia

-Pulmonary heart disease

Ramipril tablets cannot be used in the following situations due to lack of treatment experience:

-Severe renal damage (creatinine clearance <30ml/min)

-dialysis

-Primary liver disease or liver damage

-Untreated, decompensated heart failure

-Children

Diafiltration or hemofiltration of polyacrylonitrile or methallyl sulfide high-throughput membranes (eg AN69) should not be used during treatment with ramipril tablets.

If dialysis or hemofiltration is urgently needed, it must first be converted to another type of (non-AcE inhibitor) antihypertensive or acute myocardial infarction treatment for heart failure, or a different dialysis membrane must be used (see "Caution" matter"). In patients with oral ACE inhibitors, a life-threatening allergic reaction may occur when LDL (Low Density Lipoprotein) separation is removed using dextran sulfate.

Children of childbearing age must exclude pregnancy before giving ramipril tablets, and these women must take appropriate contraception during treatment with ramipril tablets. If a pregnancy occurs during treatment with ramipril tablets, other treatments that are less dangerous for children must be taken after consulting a doctor because ramipril tablets are taken during pregnancy, especially during the last 6 months of pregnancy. Causes fetal damage.

If ramipril tablets are required during breastfeeding, breastfeeding must be stopped.

Child medication:

Ramipril tablets have not been studied in children and are not recommended for patients in this age group.

Geriatric patient medication:

In the elderly who use diuretics, congestive heart failure or renal function or liver dysfunction, the use of ramipril tablets should be cautious. The dose should be carefully adjusted according to the needs of blood pressure control.

Drug interaction

  

Combination with ramipril tablets or other ACE inhibitors has the following interactions:

-Sodium chloride can attenuate the antihypertensive effect of ramipril tablets and alleviate the symptoms of heart failure.

-Antihypertensive drugs (especially diuretics) and other potentially antihypertensive drugs (such as nitrates, tricyclic antidepressants, anesthetics) enhance the antihypertensive effect of ramipril tablets.

-Analgesics, anti-inflammatory drugs (such as acetylsalicylic acid, indomethacin) may reduce the antihypertensive effect of ramipril tablets.

-potassium salts, potassium-sparing diuretics (such as spironolactone, amiloride, triamterene) and other drugs that cause elevated potassium levels (such as heparin) can significantly increase serum potassium levels.

-Lithium salts can cause an increase in serum lithium concentration (requires regular monitoring).

-Ethanol increases the antihypertensive ability of ramipril, and ramipril enhances the effect of alcohol.

-hypnotics, anesthetics can make the antihypertensive effect more obvious (the anesthesiologist should be notified when treated with ramipril)

-Allopurinol, cytostatics, immunosuppressants, systemic cortisol, procainamide can reduce blood leukocyte count; leukopenia.

-Ramipril enhances the hypoglycemic effect of oral hypoglycemic agents (such as sulfonylureas/biguanides) and insulin.

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 详细处方信息以本药内容附件PDF文件(201883007595139.pdf)的“原文Priscribing Information”为准
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更新日期: 2017-10-20
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