Моносорб
Producer: LLC Pharmtekhnologiya Republic of Belarus
Code of automatic telephone exchange: C01DA14
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 0,02 g (20 mg) and 0.04 g (40 mg) of mononitrate isosorbide (in the form of isosorbide of mononitrate divorced).
Excipients: starch corn, talc, silicon dioxide colloid anhydrous, magnesium stearate, lactose monohydrate, cellulose microcrystallic.
The cardiological drug possessing anianginalny, koronaro-and vasodilating action, and also preventing stenocardia attacks.
Pharmacological properties:
Pharmacodynamics. Anti-anginal drug. Isosorbide mononitrate concerns to group of peripheral vazodilatator with preferential influence on venous vessels. Increases the content of nitrogen oxide in an endothelium, stimulates guanylate cyclase and formation of tsGMF. reduces concentration of calcium in cells of unstriated muscles. Causes reduction of need of a myocardium for oxygen due to reduction of a predpagruzka (expansion of peripheral veins and reduction of inflow of blood to the right auricle) and afterloads (OI ICC reduction), 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 mat a blood circulation circle.
At administration of drug of Monosorb the anti-anginal effect is shown in 30 min. and proceeds 2-6 h.
Pharmacokinetics. Absorption. After isosorbide intake mononitrate is quickly and completely absorbed from a GIT. Bioavailability makes 90-100% and does not depend on features of a diet (caloric content, the high or low content of fats) and meal time. Concentration in a blood plasma is directly proportional to the accepted dose. Metabolism. Isosorbide монопитрат almost it biotransformirutsya completely in a liver with formation of inactive metabolites to isosorbide or by means of conjugation with glyukuroiovy acid and education inactive 2 glucuronides.
Removal. It is removed by kidneys preferential in the form of metabolites. 2% - in an invariable look. Ti/2 makes 4-5 h.
Pharmacokinetics in special clinical cases. The pharmacokinetics of isosorbide of mononitrate of nanosecond changes at persons of advanced and senile age, and also at patients with a chronic renal and liver failure.
Indications to use:
- prevention of attacks of stenocardia (including in the postinfarction period);
- 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:
Моносорб accept inside after food, without chewing, washing down with a small amount of liquid. The mode of dosing is set individually. The initial dose makes 10–20 mg 2 times a day (tablets can be divided). If necessary from the 3-5th day of treatment it is possible to increase a dose of drug to 20–40 mg 2 times a day. The maximum daily dose should not exceed 80 mg.
Features of use:
Моносорб do not apply to stopping of attacks of stenocardia.
With care appoint to patients with glaucoma, with the increased intracranial pressure.
Management of transport and mechanisms. 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.
Pregnancy and lactation. 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.
Side effects:
From cardiovascular 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 Monosorba with anti-hypertensive means, beta adrenoblockers, blockers of calcium channels, phosphodiesterase inhibitor - sildsnafily. strengthening of antigipertenzivpy action is possible.
The anti-hypertensive effect is strengthened also by neuroleptics, tricyclic antidepressants and ethanol.
At simultaneous use of Monosorba and dihydroergotamine strengthening of hypertensive action and increase in concentration of dihydroergotamine in a blood plasma is possible.
At simultaneous use of Monosorba and Norepinephrinum (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 hg, diastolic the ABP - less than 60 mm hg);
- hypertrophic subaortic stenosis;
- constructive pericardis;
- cardiac tamponade;
- hematencephalon;
- primary pulmonary hypertensia;
- glaucoma;
- children's and teenage age up to 18 years;
- hypersensitivity to organic nitrates.
Overdose:
About cases of overdose it was not reported. Treatment: in case of overdose it is necessary to cause artificial vomiting, to wash out a stomach, to control hemodynamics indicators.
Storage conditions:
To store in the place protected from moisture and light at a temperature not above +25 °C. To store in the place, unavailable to children. Period of validity 2 years.
Issue conditions:
According to the recipe
Packaging:
Tablets on 20 mg and 40 mg in a blister strip packaging No. 10x3, No. 10x6, in banks polymeric No. 60 and in banks from polyethyleneterephthalate No. 60. Together with a leaf insert the 3 or 6 blister strip packagings, banks polymeric and banks from polyethyleneterephthalate are located in packs from a cardboard.