Монокапс ретард

General characteristics. Structure:

Active ingredient: 40 mg or 50 mg of isosorbide of mononitrate.

Excipients: ethyl cellulose, talc, lactose, sucrose, starch corn.

Structure of a cover of the capsule: gelatin, глицерол, sodium lauryl sulfate, the water purified dyes.

Cardiological drug with preferential anti-anginal and vasodilating action.

Pharmacological properties:

Pharmacodynamics. Isosorbide mononitrate - a peripheral vazodilatator with preferential influence on venous vessels, anti-anginal means.

Increases the content of nitrogen oxide in an endothelium, stimulates guanylate cyclase and education ts-GMF, reduces concentration of calcium in cells of unstriated muscles. Causes reduction of need of a myocardium for oxygen due to reduction of preloading (expansion of peripheral veins and reduction of inflow of blood to the right auricle) and afterloads (reduction of OPSS), and also has coronarodilator effect. Improves a coronary blood stream, promotes its redistribution to ischemic areas, reduces the final diastolic volume of a left ventricle and reduces the systolic tension of its walls. Increases tolerance to an exercise stress at patients with an ischemic heart disease, stenocardia. Reduces pressure in a small circle of blood circulation. 

Active agent of Monokaps ретард consists of 2 parts, one of which acts directly after administration of drug, another – gradually for a long time. Thus, drug works quickly and is long concerning the prevention of attacks of stenocardia. Bioavailability of isosorbide of mononitrate does not depend on features of a diet (caloric content, the high or low content of fats) and meal time.

Pharmacokinetics: After isosorbide intake mononitrate is quickly and completely absorbed from a GIT. Bioavailability makes 90-100%. Concentration in a blood plasma is directly proportional to the accepted dose.

Isosorbide mononitrate almost biotransformirutsya completely in a liver with formation of inactive metabolites by a denitratation to isosorbide or by means of conjugation with glucuronic acid and education inactive 2 glucuronides.

2% - in an invariable look are removed by kidneys preferential in the form of metabolites. TCmax makes 8 h. 

The pharmacokinetics of isosorbide of mononitrate does not change at persons of advanced and senile age, and also at patients with a chronic renal and liver failure.

The special compounding of Monokaps ретард with the slowed-down release of active agent guarantees that after a single daily dose concentration of isosorbide of mononitrate in blood provides therapeutic action for 24 h.

Indications to use:

Монокапс ретард it is shown for prevention and treatment of stenocardia of the III-IV functional class, in the postinfarction period at a spasm of peripheral arteries (an obliterating endarteritis, an angiospastic retinitis).

It is applied as a part of a combination therapy at treatment of chronic heart failure, some forms of pulmonary hypertensia and a pulmonary heart.

Route of administration and doses:

Монокапс ретард accept inside, on 1 capsule in the morning after a breakfast, washing down with a small amount of water.

Frequency of reception and duration of treatment are established individually and depend on indications and efficiency of the carried-out therapy.

Features of use:

Монокапс ретард do not apply to stopping of bad attacks of stenocardia, an acute myocardial infarction. With care appoint the patient with glaucoma, with the increased intracranial pressure, an aortal and/or mitral stenosis, tendency to arterial hypotension, patients with disturbance of cerebral circulation and the expressed renal failures.

At prolonged use tolerance development in this connection it is recommended to do after 3-6 weeks of regular administration of drug a break for 3-5 days is possible, having replaced with this time of Monokaps ретард with other anti-anginal drugs. At administration of drug there can be a temporary anoxemia due to relative redistribution of a blood-groove in the hypoventilated alveolar zones. At patients with an ischemic heart disease it can lead to a temporary hypoxia of a myocardium.

During treatment by Monokaps ретард it is necessary to exclude alcohol intake.

At reception of medicine decline in the ability to concentration of attention and speed of psychomotor reactions, in communication is possible with what the control of vehicles and occupations is not recommended by other potentially dangerous types of activity.

Side effects:

From outside warmly – vascular system: in an initiation of treatment the "nitrate" headache (usually disappearing in several days is possible at treatment continuation). The arterial hypotension (including orthostatic) which is followed by reflex tachycardia, block, dizziness, weakness is possible. Seldom at the expressed arterial hypotension - strengthening of symptoms of stenocardia (paradoxical influence of nitrates); in some cases – a collapse, a bradyarrhythmia, a syncope. From the alimentary system: seldom – nausea, vomiting. Dermatological reactions: perhaps tranzitorny erubescence; in some cases – exfoliative dermatitis. Allergic reactions: skin manifestations are possible. Other: in some cases – reduction in the rate of psychomotor reactions.

Interaction with other medicines:

At simultaneous use of Monokaps ретард with anti-hypertensive means, a beta – adrenoblockers, blockers of calcium channels, phosphodiesterase inhibitor – sildenafily (viagra) strengthening of anti-hypertensive action is possible.

The anti-hypertensive effect is strengthened also by neuroleptics, tricyclic antidepressants and alcohol.

At simultaneous use of Monokaps ретард and dihydroergotamine strengthening of hypertensive action and increase in concentration of dihydroergotamine in a blood plasma is possible.

At simultaneous use of Monokaps ретард and noradrenaline the therapeutic effect of the last decreases.

Barbiturates accelerate biotransformation and reduce concentration of isosorbide of mononitrate in a blood plasma. 

The adsorbents knitting and enveloping means reduce mononitrate isosorbide absorption in a GIT.

Contraindications:

Contraindications to use are:
• acute disorders of blood circulation (shock, vascular collapse);  
• hemorrhagic stroke;
• an acute myocardial infarction with the lowered filling pressure of a left ventricle;
• the expressed arterial hypotension (systolic the ABP less than 90 mm of mercury., diastolic the ABP – less than 60 mm of mercury.);
• hypertrophic subaortic stenosis;
• constructive pericardis;
• cardiac tamponade;
• hematencephalons;
• primary pulmonary hypertensia;
• glaucoma;
• children's and teenage age up to 18 years;
• hypersensitivity to organic nitrates;

At pregnancy and in the period of a lactation appointment is possible only according to strict indications when the expected effect for mother exceeds potential risk for a fruit or the child.

Storage conditions:

Store in the place protected from moisture and light at a temperature from 15 °C to 25 °C. Store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in blister strip packagings, on 3 strip packagings in a cardboard box.