45．德脉宁

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254页（8049字）

【中文释文】：

缓释胶囊(40mg)

别名：5-单硝异山梨醇酯缓释胶囊

〔成分〕

每粒胶囊内含5-单硝异山梨醇酯40mg

其它成分：蔗糖、玉米淀粉、硬酯酸-棕榈酸、乙基纤维素、滑石粉、色素E171、E172等。

〔适应证〕

用于心血管血流障碍(冠状血管性心脏病)的持续治疗。

心绞痛的预防和治疗；

心肌梗塞治疗后心绞痛的康复治疗；

肺循环性高压；

严重的心肌损害(慢性心功能不全)；

与强心甙和／或利尿剂联合应用治疗慢性心功能不全。

〔禁忌证〕

对硝酸酯类药物过敏者；

休克状态、严重低血压；

肥厚性梗阻性心肌病；

狭窄性心包炎、心包填赛；

急性心肌梗塞并发舒张压降低者。

〔注意事项〕

尽管本药在动物实验中无胚胎损害作用，孕妇还是应慎遵医嘱，因为缺乏有关用药经验。

长期连续用药会出现耐药性。为避免这种情况连续用药时应尽量低剂量维持。

原因不明性肺循环高压者(原发性肺动脉高压者)用药后可能会出现动脉含氧量减少，因为流经肺下部(肺泡换气量较差的区域)的血液增多，这也特别多见于冠状动脉血流障碍者。

〔副作用〕

用药初期常有头痛(所谓硝酸盐性头痛)，多数会在继续服药几天后消失；初次或高剂量用药时会出现血压下降，伴有反射性脉搏加快、眩晕及乏力等；偶见恶心、呕吐及皮肤过敏等现象。

〔剂量和用法〕

主要取决于病情并遵照医嘱。一般每日1次，每次1粒胶囊，特别情况每日2次，每次1粒胶囊。饭后伴少许饮液吞服(勿嚼)。长期服药后停药时避免骤然停药，应逐渐减量，否则会出现停药反应。

〔包装〕

每盒30粒缓释胶囊。

〔生产厂家〕

德国Merckle GMBH生产。

(附本品别名：长效心痛治，异乐定，异山梨糖醇单硝酸酯，Elantan，Pentacard)

【外文释文】：

Active ingredient：isosorbide 5-mononitrate

Composition

Medicinally active component

1 sustained-release capsule contains：

Isosorbide 5-mononitrate 40 mg

Other components：

Sucrose，corn starch，stearic-palmitic acid，ethyl cellulose，talcum，pigmengs E171，E172

Indications

·Chronic treatment of ciruclatory disturbances of the coronary vessels of the heart(coronary heart disease)

·Prophylaxis of angina pectoris attacks(heart pain)

·Treatment after heart attack when there is existing angina pectoris

·High presure in the pulmonary(lung)circulation

·Treatment of severe weakness of the heart muscles(cardiac insufficiency)，in combination with cardiac glycosides and／or diuretics

Contraindications

Is 5 mono retard-ratiopharm 40 must not be taken in caes of

·Hypersensitivity to nito compounds

·Acute heart attack with low filling pressure

·Restricted function of the left chamber of the heart(left cardiac insufficiency)with low filling pressure

·States of shock

·Very low blood pressure

·Heart muscle disease with constriction of the internal volume of the heart(hypertrophy，obstructive cardiomyopathy)

·Constrictive inflammation of the heart membrane(constrictive pericarditis)

·Heart tamponade(pericardial tamponade)

Note

The administration of IS 5 mono retard-ratiopharm 40-particularly to patients with high lung circulation pressure of unknown orign(primary hulmonary hypertension)-can lead to a temporary reduction in the oxygen content of the arterial blood(hypoxaemia)as a result of a relative increase in the blood supply to underventilated sections of the lung(hypoventilated alveolar areas)．This is particularly the case for patients with circulatory disturbances of the coronary vessels of the heart(coronary heart disease)．

Particularly careful medical supervision is necessary in cases of

·Aortal and／or mitral stenosis

·Tendency towards disturbances of circulatory regulation(orthostatic circulatory regulation disturbances)

·Disease accompained by elevated pressure within the skull(intracranial pressure)(a further increase in pressure has until now only been observed after the high dose i．v．administration of glycerol trinitrate)

·Patients with severe disturbances of kidney function．

IS 5 mono retard-ratiopharm 40 is not suitable for the treatment of acute angina pectoris．

Administration during pregnancy and breast feeding：

Although no embryotoxic effects have been observed in animal experiments isosorbide 5-mononitrate should only be taken during pregnancy and when breast feeding if it is specifically medically prescribed since no experience is available of admini-stration to pregnant women and nursing mothers．

Side effects

Headaches(“nitrate headaches”)frequently occur at the start of treatment：experience has shown that these usually disappear after a few days if treatment is continued．Particularly with the first treatment，but also when the dose is increased，there is frequently a fall in blood pressure，which can be associated with a reflex increase in the pulse rate and with a feeling of dizziness and lassitude．Occasionally there can be neusea，vomiting，transient reddening of the skin with a hot sensation(flush)and allergic skin reactions．In rare cases there can be a severe drop in blood pressure with an increase in the severity of the angina pectoris symptoms(paradoxical nitrate effect)and／or marked paradoxical bradycardia(slowing of the pulse rate)．There have been occasional reports of states of collaps and syncope(sudden loss of consciousness)．An exfoliative dermatitis(inflammatory skin disease)can occur in individual cases．There hve been descriptions of the development of tolerance and the occurrence of cross-tolerance with other nitro compounds under continuous chronic treatment with high doses of isosorbide 5-mononitrate．Continuous high doses should be avoided in order to prevent weakening or loss of effectivity．

Special note：

Even when taken as prescribed this medicament can alter the reactions to such a degree that it affects the ability to taken an active part in road traffic or to operate machinery．This is true to a greater extent in combination with alcohol．

Interactions with other preparations

The simultaneous taking of preparations to lower the blood pressure(antihypertensives)，β-blockers，calcium antagonists，other vessel-expanding preparations(vasodilators)，neuroleptics or tricyclics antidepressives or alcohol can increase the blood pressure-reducing effect of IS 5 mono retard-ratiopharm 40．

The blood pressure-reducing effect of dihydroergotamine can be increased by the simultaneous taking of IS 5 mono retard-ratiopharm 40．

It cannot be excluded that simultaneously taking nonsteroid antirheumatics may cause a reduction in the effect of IS 5 mono retard-ratiopharm 40．

Dosage instructions

Unless otherwise prescribed，1 time 40 mg isosorbide 5-mononitrate(corresponding to 1 time 1 sustained-release capsule)per day．In exceptional cases the dose can be increased to 2 times 40 mg isosorbide 5-mononitrate(corresponding to 2 times 1 sustained-release capsule)per day．

Note：

When the daily dose is 2 times 40 mg isosorbide 5 mononitrate(corresponding to 2 times 1 sustained-release capsule)，then the 2nd capsule should be taken not more than 8 hours after the 1st capsule in order to maintain the full effect of the medica-ment．

Mode and duration of administration

The sustained-release capsules should be taken unchewed with a little fluid after meals．Treatment with IS 5 mono retard-ratio-pharm 40 should be ended gradually and not abruptly，since the ppssibility of rebound phenomena cannot be excluded．The preparation must not be used after the expiry date．

Store out of reach of childrenl

Manufacturer

Merckle GmbH，Germany