46.长效易顺脉

出处:按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第258页(10158字)

【中文释文】:

冠心病治疗剂

〔成分〕

长效易顺脉20mg,每个胶囊内含20mg缓释持续起作用的二硝酸异山梨醇酯。长效易顺脉40mg,每个胶囊内含40mg缓释持续起作用的二硝酸异山梨醇酯。

〔特点〕

长效易顺脉迅速起作用后,可减少心脏的前后负荷,使心脏的血流动力学以及心脏需氧状况得到长时间的改善。这样可预防心绞痛的发作。通过一种特别缓释制剂,其活性物质可持续缓慢释放出来。机体的耐受性通常良好。

〔适应证〕

可持久地用于治疗冠心病的冠脉血流障碍,预防心绞痛发作,心肌梗塞后心绞痛的续后治疗,肺动脉高压治疗,和强心甙或利尿剂合并使用治疗严重心肌功能不全(慢性心力衰竭)。

〔禁忌证〕

禁忌证指的是不能服用某些药物的疾病和情况,或者指可能出现对机体有损害而必须经医生衡量得失后才能使用者。因此,医生必须询问病人的既往病史,并存的疾病,合并用药和病人的生活习惯和特点,以便决定是否有禁忌证。有些禁忌证可能在接受治疗才出现,如果这样要及时通知医生。

消心痛不能用于:

对有机硝酸酯脂过敏者;

急性心肌梗塞伴低充盈压者;

左室功能不全伴低充盈压者;

休克;

血压非常低者。

由于心脏内部狭窄而出现的心肌功能不全(阻塞性心力衰竭)例如:主动脉瓣狭窄、二尖瓣狭窄或缩窄性心包炎。小气道畸形者(例如肺泡性低氧血症)出现的冠脉循环障碍者,因为此时肺部通气较好部位的血流可由于流向通气不良的部位而减少。

下列情况用药时应加以注意:

由于低血压而出现循环张力调节障碍者(直立性低血压)。

伴有颅内压升高的疾病(虽然既往只观察到静脉给予大剂量硝酸甘油时才会升高颅内压)。另外应注意,孕妇必须在医生的指导下才能使用长效易顺脉,虽然动物实验未见到它对胎儿有任何的损害。

此制剂不宜用于心绞痛急性发作期的治疗。

〔副作用〕

除了临床需要的作用以外,药物所产生的临床不需要的作用被称为副作用。下述的副作用常在服用长效易顺脉后出现,但并不是所有的病人都会出现。

由于长效易顺脉的血管扩张作用,开始给药时可出现头痛,继续给药数天后头痛常可消失。

血压可略有下降,尤其是开始给药或增加剂量时。

此外,恶心、呕吐、头晕、无力、心率增快、皮肤潮红均可在开始治疗时出现。

过敏性皮肤反应和/或剥脱性皮炎(炎症性皮肤反应)偶见。

有报道个别病例出现虚脱和晕厥。

偶见伴有血压急剧下降而出现的心绞痛加剧(有机硝酸酯反常反应)。

尽管按照用药原则使用此药,有时可能出现一些其他副作用,例如可能影响司机或机器操作工人的反应能力,尤其是与酒精一起服用时。

〔与其他药物的相互作用〕

有些药物与此药同用时会互相影响。因此病人应将其常用的药物,新近加用的药物告诉医生。或者将这些药物合在一起使用时应该与医生商量。医生会告知你这样做是否会减低药物的效应,或者是否需要调整剂量。

下列的药物可能产生相互作用:

联用抗高血压药、钙拮抗剂、其他血管扩张药、精神安定剂或三环类抗抑郁药、酒精等,均可加重长效易顺脉的降低血压效应。

联用长效易顺脉可增强二氢麦角胺的增压作用。

未能排除长效易顺脉可以减低非激素类抗风湿药的作用强度。

〔剂量及用法〕

长效易顺脉20mg:一般为1粒,每天2次,如需用大剂量有机硝酸酯,可改每日3次。胶囊和水吞服,不能嚼破。

疗程由医生决定。

长效易顺脉40mg:一般为1粒,每日1次,部分病人可每日3次。为了获得药物的全效作用,第二次服药间歇不超过第一次的6h后,胶囊和水吞服,不能嚼破。

疗程由医生决定。

〔注意〕

有效期后的药物不能服用,有时胶囊未满但药量可保证。

贮存于25℃以下,保持干燥。

药物应小心保存!不能被儿童触及!

〔生产厂家〕

德国Heinrich Mack生产

(附本品别名:异舒吉)

【外文释文】:

Active agent:Isosorbide dinitrate Coronary therapeutic agents

Composition

Iso Mack Retard 20 mg

1 capsule with sustained action contains: 20 mg

Isosorbide dinitrate

Iso Mack Retard 40 mg

1 capsule with sustained action contains:

Isosorbide dinitrate 40 mg

Properties

After a rapid onset of action Lso Mack Retard 20 mg and Iso Mack Retard 40 mg reduce the preload and the afterload,producing long-lasting haemodynamic heart relief and thereby lowering the myocardial oxygen requirement.This prevents the onset of angina pectoris attacks.The active substance is continuously released by a special retard formulation.Tolerability is generally good.

Indications

Long-term treatment of circulatory disturbances in the coronary vessels(coronary heart disease).Prevention of angina pectoris attacks(cardialgia).Follow-up treatment of myocardial infarction when angina pectoris exists.Pulmonary hypertension.Treatment of severe myocardial insuffi-ciency(chronic heart failure),in combination with cardiac glycosides and/or diuretics.

Contra indications

Contra indications are diseases or conditions in which certain drugs must not be taken,or may be used only after careful consideration by the physician,as the anticipated benefit in such cases is generally out of proportion to the possible damage.The physician should be informed of previous diseases,concomitant diseases,any concomitant treatment,and of your particular lifestyle and habits,so that he can check whether there are any contra-indications.Contra indications may also occur or become known only after treatment with this drug has started.In these cases too your physician should be informed.

Isosorbide dinitrate must not be used in cases of:

Hypersensitivity to nitro compounds.

Acute myocardial infarction with low filling pressures.

Left-ventricular insufficiency with low filling pressures.

States of shock.

Very low blood pressure.

Myocardial insufficiency due to constriction of the interior of the heart(obstructive heart failure),e.g.in aortic or mitral stenosis or constrictive pericarditis.

Patients with circulation disturbances in the coronary vessels who are suffering from malformations of the lesser airways(e.g.alveolar hypoxia),since the blood flow to undersupplied regions may be increased at the expense of better-ventilated parts of the lung.

Particularly careful medical supervision is necessary in cases of:

Tendency to circulatory regulation disturbances due to low blood pressure(orthostatic circulatory regulation disturbances).

Diseases accompanied by elevated intracranial pressure(a further increase in pressure has in the past been observed only after i.v.administration of high doses of glycerol trinitrate).

As a special precaution,isosorbide dinitrate should only be taken during pregnancy on the express instructions of your physician.Studies in animals have not shown any evidence of damage to the embryo.

The products are not suitable for the treatment of acute angina pectoris attacks.

Side effects

In addition to the desired main effects,drugs can also produce adverse effects,so-called side effects.The following side effects linked in time with the administraiton of isosorbide dinitrate have been observed,though they do not necessarily occur in all patients:

Because of the vasodilating action of isosorbide dinitrate,headaches may occur at the beginning of treatment;these usually disappear when the drug has been taken for a further few days.

A drop in blood pressure may occur,particularly on first use,but also when the dose is increased.In addition,nausea,vomiting,a feeling of dizziness and weakness,increased pulse rate and reddening of the skin(flush)may occur at the beginning of therapy.

Allergic skin reactions and/or exfoliative dermatitis(inflammatory skin reaction)may occasionally occur.

Collapse and syncope(loss of consciousness)have been reported in isolated cases.

In rare instance the angina pectoris symptoms may be intensified,with a sharp fall in blood pressure(paradoxical nitrate reaction).

Even used according to instructions these drugs may change the reactivity to such an extent as to impair the ability to operate a motor vehicle or mchinery.This applies particularly in combination with alcohol.

Interaetions with other substances

The effects of some drugs can be influenced by concomitant use of other drugs.You should therefore consult your physician if you are taking other drugs regularly,have recently used other drugs,or if you wish to use them concomitanly with these druge.Your physician will be able to tell you whether intolerance can be expected in these circumstances,or wheter special measures such as the establishment of a new dose are necessary if you take this drug.

The following interactions with these drugs should be noted:

Concomitant use of antihypertensives,calcium antagonists,other vasodilators,neuroleptics or tricyclic antidepressants,and alcohol can potentiate the blood lowering action of Iso Mack Retard 20 mg and Lso Mack Retard 40 mg.

The blood pressure increasing action of dihydroergotamine may be potentiated by the concomitant use of Iso Mack Retard 20 mg or Iso Mack Retard 40 mg.

A weakening of action as a result of taking non-steroidal antirheumatics cannot be ruled out.

Dosage and administration

Iso Mack Retard 20 mg

Unless otherwise prescribed,1 capsule of Iso Mack Retard 20 mg twice daily.In cases of a higher nitrate requirement,the daily dose may be increased to 1 capsule three times daily.The capsule should be taken unchewed with some liquid after mels.

The duration of treatment should be determined by the physician.

Iso Mack Retard 40 mg

Unless otherwise prescribed,1 capsule of Iso Mack Retard 40 mg once daily.In exceptional cases the dose may be increased to 1 capsule twice daily.To obtain the full effect of the drug,patients receiving a dose of 1capsule twice daily should take the second dose not more than 6 hours after the first.The capsules should be taken unchewed with some liquid after meals.

The duration of treatment should be determined by the physician.

Note

Iso Mack Retard 20 mg and Lso Mack Retard 40mg should not be used after the expiry date stated on the package.

Even though the capsules are not completely filled,their contents correspond in all cases to the declared amount of active substance.

Do not store above 25℃(77°F).Keep dry.

Medicines should be stored with care.Keep away from children.

Manufacturer

Heinrich Mack Nachf.

Illertissen Fed.Rep.of Germany

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