Монокапс
Producer: Minskinterkaps Unitary Enterprise Republic of Belarus
Code of automatic telephone exchange: C01DA14
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: 20 mg or 40 mg of isosorbite of mononitrate.
Excipients: magnesium stearate, potato starch, lakyotoz.
Structure of a cover of the capsule for a dosage of 20 mg: gelatin, glycerin, sodium lauryl sulfate, the water purified titanium dioxide.
Structure of a cover of the capsule for a dosage of 40 mg: gelatin, glycerin, sodium lauryl sulfate, the water purified titanium dioxide, dye red ocharovatelyyony E-129.
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
At mononitrate isosorbide reception the anti-anginal effect is shown in 30 minutes after reception and 2-6 hours proceed. 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. T1/2 makes 4-5 hours.
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.
Indications to use:
Монокапс it is shown for prevention of attacks of stenocardia, in the postinfarction period. 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:
Frequency of reception and duration of treatment are established individually. Монокапс accept inside 20 - 40 mg on reception 2-3 times a day with an interval of 7 - 8 hours after food.
Features of use:
Монокапс do not apply to stopping of attacks of stenocardia. With care appoint the patient with glaucoma, with the increased intracranial pressure.
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.
Others: in some cases – reduction in the rate of psychomotor reactions.
Interaction with other medicines:
At simultaneous use of Monokaps 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 and dihydroergotamine strengthening of hypertensive action and increase in concentration of dihydroergotamine in a blood plasma is possible.
At simultaneous use of Monokaps and noradrenaline the therapeutic effect of the last decreases.
Barbiturates accelerate biotransformation and reduce concentration of isosorbide of mononitrate in a blood plasma.
Contraindications:
• 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 the blister, on 3 blisters in a pack.