Active substanceMeldoneyMeldoney
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  • Dosage form: & nbspcapsules
    Composition:

    Active substance: meldonium dihydrate (trimethylhydrazinium propionate dihydrate) 250 mg and 500 mg.

    Excipients: potato starch, silicon dioxide colloid (aerosil), calcium stearate.

    Capsule shell composition:

    Dosage of 250 mg

    Hard gelatin capsules №1

    Body and lid: gelatin, titanium dioxide

    Dosage 500 mg

    Hard gelatin capsules №00

    Case: жelatin, titanium dioxide

    Cap: gelatin, titanium dioxide, dye quinoline yellow, dye sunset yellow.

    Description:

    Dosage of 250 mg. Capsules hard gelatin №1 white.

    Dosage 500 mg. Capsules hard gelatinous №00, the case of white color, a lid of yellow color.

    The contents of the capsules are a white crystalline powder with a specific odor. The powder is hygroscopic.

    Pharmacotherapeutic group:Metabolic means
    ATX: & nbsp

    C.01.E.B.22   Meldoney

    C.01.E.B   Other drugs for the treatment of heart disease

    Pharmacodynamics:

    Meldonium is an analog of gamma-butyrobetaine, it suppresses gamma-butyrobetaine hydroxinease,reduces the synthesis of carnitine and the transport of long chain fatty acids through the cell membranes, prevents the accumulation of activated forms of unoxidized fatty acids - the derivatives of acylcarnitine and acylcoenzyme A. As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine is strongly synthesized, which has vasodilating properties.

    Under conditions of ischemia, it restores the equilibrium of the processes of oxygen delivery and its consumption in cells, prevents the violation of ATP transport; simultaneously, it activates glycolysis, which proceeds without additional consumption of oxygen.

    The mechanism of action determines the variety of its pharmacological effects: increasing efficiency, reducing the symptoms of mental and physical overstrain, the activation of tissue and humoral immunity, cardioprotective effect. In the case of acute ischemic damage, the myocardium slows the formation of the necrotic zone, shortens the rehabilitation period. With heart failure increases myocardial contractility, increases exercise tolerance, reduces the incidence of angina attacks.In acute and chronic ischemic disorders of cerebral circulation improves blood circulation in the ischemic focus, promotes redistribution of blood in favor of the ischemic site. Effective in the case of vascular and dystrophic pathology of the fundus. Characteristic is also a tonic effect on the central nervous system, the elimination of functional disorders of somatic and autonomic nervous systems in patients with alcoholism during the period of abstinence.

    Pharmacokinetics:

    After ingestion, the drug is rapidly absorbed, bioavailability is 78%. The maximum concentration in the blood plasma is achieved 1-2 hours after ingestion. Metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life for oral use depends on the dose, is 3-6 hours.

    Indications:

    As a part of combined therapy of coronary heart disease, chronic heart failure, cardialgia against dyshormonal myocardial dystrophy.

    Disorders of the blood supply to the brain (stroke, cerebrovascular insufficiency). Complex therapy of abstinence alcohol syndrome.

    Reduced performance, chronic physical overstrain, postoperative period to accelerate rehabilitation processes.

    Contraindications:

    Hypersensitivity to the drug, increased intracranial pressure (with violation of venous outflow and intracranial tumors), pregnancy, lactation, age under 18 years (efficacy and safety not established).

    Pregnancy and lactation:

    Not recommended in pregnancy (efficacy and safety of use not studied). If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside, before eating.

    Stable angina, chronic heart failure - in the complex therapy of 500-1000 mg per day, applying the entire dose at once or dividing it by 2 times. The course of treatment is 4-6 weeks.

    Cardialgia against the background of dyshormonal myocardial dystrophy - 250 mg twice a day (morning and evening). The course of treatment is 12 days.

    Infringements of a blood supply of a brain (an insult, a cerebrovascular insufficiency) - on 500-1000 mg a day, it is desirable in first half of day. The course of treatment is 4-6 weeks.

    An abstinent alcoholic syndrome - 500 mg 4 times a day. The course of treatment is 7-10 days.

    With a decrease in working capacity and chronic physical overstrain, in the postoperative period to accelerate the rehabilitation processes - 250 mg 4 times a day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks. Athletes are prescribed 500-1000 mg 2 times a day before training. The duration of the course in the preparatory period is 14-21 days, during the competition - 10-14 days.

    Side effects:

    Rarely - allergic reactions (reddening of the skin, itching, swelling), dyspepsia, tachycardia, agitation, lowering blood pressure.

    Overdose:

    There is no information.

    Interaction:

    Strengthens the coronarodilating and some hypotensive drugs, cardiac glycosides. You can combine with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmics, diuretics, bronchodilators. In view of the possible development of moderate tachycardia and arterial hypotension, caution should be exercised in combination with peripheral vasodilators and antihypertensive agents (including nifedipine,alpha-adrenoblockers).

    Special instructions:

    Can give a positive result in the conduct of doping control.

    Form release / dosage:

    Capsules of 250 mg and 500 mg.

    Packaging:

    10 capsules per contour cell package.

    3 or 6 contour squares with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In dry place inaccessible to children at a temperature not exceeding 25 ° C.

    Shelf life:

    4 years. Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000797/09
    Date of registration:06.02.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.04.2018
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