Active substanceMolsidomineMolsidomine
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  • Dosage form: & nbspPills.
    Composition:tablet 2 mg:
    active substance:
    molsidomine 2 mg
    Excipients: lactose, sucrose, potato starch, dye-based aluminum dye sunset yellow [E110], povidone K-25, magnesium stearate.
    tablet 4 mg:
    active substance:
    molsidomine 4 mg
    Excipients: lactose, sucrose, potato starch, lacquer aluminum based on the dye crimson [Ponso 4R] [E 124], povidone K-25, magnesium stearate.
    Description:Round tablets, flat on both sides, with bevelled edges, on the one hand risk. Allowed on the surface of the tablets are single inclusions of dark color. Tablets with a dosage of 2 mg are a light orange non-uniform color. Tablets with a dosage of 4 mg - a pink, non-uniform color.
    Pharmacotherapeutic group:Vasodilating agent.
    ATX: & nbsp

    C.01.D.X.12   Molsidomine

    Pharmacodynamics:Molsidomine is a derivative of sidnonimine. The active metabolite of molsidomine is linsidomine (SIN 1A), a compound that reduces the tone of smooth muscles in the walls of blood vessels and has an antiaggregant effect.Relaxation of smooth muscles is facilitated, among other things, by an increase in the volume of veins, thereby increasing the capacity of the vascular bed and reducing venous return, which leads to a decrease in the filling pressure of both ventricles. This, in turn, reduces the burden on the heart and improves hemodynamic conditions in the coronary circulation. Expansion of large coronary arteries causes a decrease in the overall peripheral vascular resistance, decreases the load on the heart and decreases the stress of the wall of the myocardium, which leads to a decrease in myocardial oxygen demand. Besides, molsidomine reduces spasm of the coronary arteries and expands large branches of these arteries. Anti-aggregation effect of molsidomine is of clinical importance in the therapy of coronary heart disease.
    In contrast, from nitrates, molsidomine does not cause tachycardia.
    The effect of molsidomin begins approximately 20 minutes after ingestion, the maximum effect is achieved in 30 to 60 minutes, the duration of action is from 4 to 6 hours.
    Pharmacokinetics:After oral administration molsidomine is absorbed from the gastrointestinal tract by approximately 90%.Bioavailability is about 65%, 11% associated with plasma proteins. Molsidomine biotransformiruetsya in the liver enzymatically to the active metabolite - sidnonimina 1 (SIN-1), which is then not enzymatically transformed to N-morpholino-N-aminoacetonitrile (SIN 1 A) - lansidomina. It is not known whether molsidomine or its metabolites with breast milk. Molsidomine is excreted primarily by the kidneys (90 - 95%, including 2% unchanged) and through the intestine (3 - 4%). The total ground clearance is 40 - 80 l / h, and SIN-1 - is 170 l / h.
    The half-life is 1.6 hours, and in case of severe hepatic insufficiency it increases, for example, with cirrhosis of the liver is about 13.1 hours. The half-life of the metabolite - lisidomine is from 1 to 2 hours and, as in the case of molsidomine, severe hepatic insufficiency (up to about 7.5 h). The drug is not cumulated in the body.
    Indications:- prevention of angina attacks;
    - chronic heart failure (as part of a combination therapy with cardiac glycosides, diuretics).
    Contraindications:- hypersensitivity to molsidomin;
    - shock, collapse;
    - severe arterial hypotension (systolic blood pressure less than 100 mm Hg);
    - lower central venous pressure;
    - low filling pressure of the left ventricle;
    - acute stage of myocardial infarction;
    - Pregnancy;
    - the period of breastfeeding;
    - simultaneous use of inhibitors of phosphodiesterase type 5 (PDE 5) -sildenafil, tadalafil, vardenafil - in connection with a high risk of developing arterial hypotension;
    - age under 18 years (efficiency and safety not established).
    Carefully:With glaucoma (especially closed-angle); patients with impaired cerebral circulation, with an increased intracranial pressure, with a tendency to arterial hypotension in elderly patients after acute myocardial infarction, renal / hepatic failure.
    Pregnancy and lactation:Application of molsidomine in pregnant women, especially during the first trimester, and during breast-feeding is contraindicated.
    If it is necessary to prescribe the drug during lactation, breastfeeding should be abandoned.
    Dosing and Administration:Inside.
    Dilasidoma tablets should be taken at regular intervals with a sufficient amount of liquid (about 1/2 cup). Tablets can be taken regardless of food intake.
    For the prevention of angina attacks usually apply 2 to 4 mg 1 to 2 times a day.
    If necessary, the dose can be increased to 12 - 16 mg per day (1 tablet of 4 mg 3 - 4 times).
    In elderly people, with hepatic or renal insufficiency, as well as low blood pressure, lower doses should be used.
    Side effects:From the cardiovascular system: marked decrease in blood pressure, sometimes right up to the collapse, orthostatic hypotension.
    From the central nervous system: at the beginning of treatment sometimes - a headache, in rare cases - dizziness; slowing the rate of mental and motor reactions (mostly at the beginning of treatment).
    From the gastrointestinal tract: nausea.
    Allergic reactions: reddening of the face, skin rash (very rare), itching, bronchospasm. Very rarely - the development of anaphylactic shock.
    Overdose:Symptoms of overdose are severe headache, marked decrease in blood pressure, tachycardia.
    Treatment: in the event that from the moment of taking a dose of the drug many times greater than the usual single dose, it has not been more than an hour - consider the possibility of gastric lavage.In addition, symptomatic treatment should be started.
    Interaction:With the simultaneous administration of molsidomine with peripheral vasodilators, blockers of "slow" calcium channels, hypotensive drugs and ethanol, the hypotensive effect is enhanced. With the simultaneous use of molsidomine with acetylsalicylic acid, antiplatelet activity increases.
    There is a high risk of developing hypotension with simultaneous use of phosphodiesterase 5 (PDE 5) inhibitors, such as sildenafil, tadalafil, vardenafil. Joint application. PDE 5 with molsidomine is contraindicated.
    Special instructions:The first dose is administered under the control of blood pressure.
    Dilasidum is not applicable for relief of angina attacks!
    Patients with a high risk of developing an antihypertensive reaction should individually approach the dosage of the drug.
    In the acute phase of myocardial infarction, Dilasid can only be used after stabilization of circulatory parameters.
    With renal failure, the concentration of molsidomine in the blood plasma does not change. The drug can be combined with other antianginal agents.
    If the liver function is abnormal, only with a marked decrease (increasing bromsulfalein test to 20-50%) increases the concentration of molsidomine in the blood plasma and the half-life, which may require adjustment of the dose of the drug.
    Taking into account the lactose content, the drug should not be used in patients with a rare form of congenital galactose intolerance, Lappease lactase deficiency or glucose-galactose malabsorption syndrome.
    At the time of treatment should be excluded from taking ethanol (alcohol).
    Effect on the ability to drive transp. cf. and fur:During the treatment period (especially at the beginning of therapy), it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Tablets 2 mg and 4 mg.
    Packaging:For 30 tablets per blister of Al / PVC. 1 blister (1x30) in a cardboard box together with instructions for use.
    Storage conditions:List B.
    Store in a dry, dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children.
    Shelf life:3 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014294 / 02
    Date of registration:29.10.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland
    Manufacturer: & nbsp
    Information update date: & nbsp2016-10-21
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