Active substanceMeldoneyMeldoney
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  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance: meldonia dihydrate - 500 mg;

    Excipients: potato starch dried - 27.2 mg, silicon dioxide - 10.8 mg, calcium stearate - 5.4 mg;

    capsule (body and lid): titanium dioxide (E 171) - 2%, gelatin - up to 100%.

    Description:

    Hard gelatin capsules № 00, body and lid of white color. The contents are a white crystalline powder with a faint 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 a synthetic analogue of gamma-butyrobetaine, a substance that is found in every cell of the human body. Inhibits the gamma butyrobetainehydroxinase, 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 - derivatives of acylcarnitine and acylcoenzyme A.

    Cardioprotective agent, normalizing myocardial metabolism.Under conditions of ischemia meldoon restores the equilibrium between the processes of oxygen delivery and its consumption in cells, prevents disruption of the transport of adenosine triphosphate (ATP); simultaneously, it activates glycolysis, which proceeds without additional consumption of oxygen. As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is synthesized intensively. The mechanism of action determines the variety of its pharmacological effects: an increase working capacity, reducing the symptoms of mental and physical overstrain, the activation of tissue and humoral immunity, cardioprotective action.

    In the case of acute ischemic injury of the myocardium meldoon 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 vessels 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 chronic alcoholism with withdrawal syndrome.

    Pharmacokinetics:

    After oral administration meldoon quickly absorbed, bioavailability - 78%. Time to reach the maximum concentration in the blood plasma -1-2 hours after ingestion. Metabolized mainly in the liver with the formation of two major, metabolites, which are excreted by the kidneys. The half-life (T1/2) when taken orally depends on the dose, is 3-6 hours.

    Indications:

    In the complex therapy of coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure and dyshormonal cardiomyopathy, as well as in the complex therapy of subacute and chronic disorders of the blood supply to the brain (after stroke, cerebrovascular insufficiency).

    Reduced efficiency; mental and physical overload (including athletes).

    Abstinence syndrome with chronic alcoholism (in combination with specific therapy).

    Contraindications:

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

    Carefully:In diseases of the liver and / or kidney.
    Pregnancy and lactation:

    The safety of the drug during pregnancy is not established. To avoid possible adverse effects on the fetus, MILDRONAT® is not recommended during pregnancy.

    It is not known whether meldoon in breast milk. If treatment with MILDRON® for the mother is necessary, then breastfeeding is stopped.

    Dosing and Administration:

    In view of the possible development of an exciting effect, it is recommended to apply in the first half of the day and not later than 17.00 at reception several times a day.

    1. Ischemic heart disease (angina pectoris, myocardial infarction), chronic heart failure and dyshormonal cardiomyopathy

    In the complex therapy of 500 mg - 1 g per day inside, applying the entire dose at once or dividing it by 2 times. The course of treatment is 4 to 6 weeks.

    Dyshormonal cardiomyopathy - as part of complex therapy, 500 mg orally, per day. The course of treatment is 12 days.

    2. Subacute and chronic disorders of blood supply to the brain (after a stroke, cerebrovascular insufficiency)

    As part of complex therapy after the termination of the course of injection therapy with MILDRONAT®, the drug continues to take 500 mg - 1 g per day, applying the entire dose immediately or dividing it by 2 times. The course of treatment is 4 to 6 weeks.

    With chronic disorders - in the complex therapy of 500 mg orally per day. The general course of treatment is 4 to 6 weeks.

    Repeated courses (usually 2-3 times a year) are possible after consultation with a doctor.

    3. Reduced performance; mental and physical overload (including athletes)

    For adults, take 500 mg twice a day. A course of treatment - 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.

    To sportsmen on 500 mg - 1 g inside 2 times a day prior to trainings. The duration of the course in the preparatory training period is 14-21 days, during the competition - 10-14 days.

    4. Abstinence syndrome with chronic alcoholism (in combination with specific therapy)

    Inside for 500 mg 4 times a day.The course of treatment is 7 - 10 days.

    Side effects:

    Rarely - allergic reactions (reddening and itching of the skin, skin rash, hives, angioedema), as well as - dyspeptic phenomena, tachycardia, decreased or increased blood pressure, increased excitability.

    Very rarely - eosinophilia, general weakness.

    Overdose:

    Symptoms: lowering blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.

    Treatment: symptomatic.

    Interaction:

    Strengthens the action of coronary arthritis, some hypotensive drugs, cardiac glycosides. Can be combined with prolonged forms of nitrates; other antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators.

    In view of the possible development of tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin (for sublingual use) and antihypertensive agents (especially alpha-blockers and short-acting nifedipine forms).

    Special instructions:

    Patients with chronic liver and kidney disease should be careful with prolonged use of the drug.

    There is insufficient data on the use of MILDRONAT® in children under 18 years of age.
    Effect on the ability to drive transp. cf. and fur:

    There is no evidence of the adverse effects of MILDRON® on the ability to drive vehicles and mechanisms.

    Form release / dosage:Capsules 500 mg.
    Packaging:

    10 capsules in a contour acrylic package of polyvinyl chloride film with polyvinylidene chloride coating and aluminum foil. For 2 or 6 contour packagings together with the instructions for use are placed in a cardboard box.

    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    4 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001115
    Date of registration:12.05.2011 / 21.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia
    Information update date: & nbsp09.06.2018
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