Active substanceMeldoneyMeldoney
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  • Dosage form: & nbspinjection
    Composition:

    For 1 ml of solution:

    active substance: meldonia dihydrate 100 mg / ml;

    Excipients: water for injection up to 1.0 ml.

    5 ml solution (1 ampoule) contains 500 mg meldonium dihydrate (500 mg / 5 ml).

    Description:A clear, colorless liquid.
    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 structural analogue of gamma-butyrobetaine, inhibits gamma-butyrobetaine hydroxynase, reduces the synthesis of carnitine, which leads to a decrease in the transport of long chain fatty acids through mitochondrial membranes; prevents the accumulation in the cells of activated forms of unoxidized fatty acids - derivatives of acylcarnitine and acylcoenzyme A, thus preventing their negative effect.

    Under conditions of ischemia, it optimizes 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.As a result of a decrease in the concentration of carnitine, the synthesis of gamma-butyrobetaine is enhanced, which leads to an increase in the content of nitric oxide II and causes endothelium-dependent vasodilation.

    The mechanism of action determines the variety of pharmacological effects of meldonia: increasing efficiency, reducing the symptoms of mental and physical overstrain, 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 chronic alcoholism during the period of withdrawal.

    Pharmacokinetics:

    With intravenous administration, bioavailability is 100%. The maximum concentration in plasma is achieved immediately after administration. Metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life (T1/2) is 3-6 hours.

    Indications:

    - In the complex therapy of coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure; dyshormonal cardiomyopathy.

    - In the complex therapy of acute and chronic disorders of cerebral circulation (stroke, cerebrovascular insufficiency).

    - In the complex treatment of vascular pathology of the fundus and retina of various etiologies (hemophthalmia and hemorrhage into the retina of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (including diabetic and hypertensive)).

    - Reduced performance, mental and physical overload.

    - Syndrome of withdrawal from chronic alcoholism (in combination with specific therapy of alcoholism).

    Contraindications:

    - Hypersensitivity to any of the components of the drug;

    - Increase in intracranial pressure (with violation of venous outflow and intracranial tumors);

    - pregnancy and lactation;

    - Children under 18 years of age (efficacy and safety not established).

    Carefully:Chronic liver and kidney disease.
    Pregnancy and lactation:

    The safety of use in pregnant women has not been studied, therefore, to avoid possible adverse effects on the fetus, the use of the drug is contraindicated.

    The isolation of Vasomag with milk and its effect on the health of the newborn have not been studied, therefore, if necessary, use should stop breastfeeding.

    Dosing and Administration:

    In view of the possible development of an exciting effect, it is recommended to apply the drug in the morning.

    Vasomag is prescribed intramuscularly (in / m), intravenously (iv) and parabulbar.

    The method of administration, dose and duration of treatment are set individually, depending on the indications, the severity of the condition, etc.

    Cardiovascular diseases

    In complex therapy:

    - ischemic heart disease (myocardial infarction) - in / in jet for 500-1000 mg (5-10 ml of Vasomag preparation) once a day, applying the entire dose at once or dividing it into 2 injections;

    - coronary artery disease (stable angina), chronic heart failure and dyshormonal cardiomyopathy - in / in jet 500-1000 mg per day (5-10 ml of Vasomag preparation), applying the whole dose at once or dividing it into 2 injections, or IM 500 mg 1-2 times a day. The course of treatment is 10-14 days, with the subsequent transition to oral administration. The general course of treatment is 4-6 weeks.

    Disorders of cerebral circulation

    In complex therapy in the acute phase of 500 mg (5 ml of Vasomag) 1 time per day IV for 10 days, switching to oral administration of 500-1000 mg. The general course of treatment is 4-6 weeks.

    With chronic cerebral circulatory insufficiency (dyscirculatory encephalopathy) of 500 mg (5 ml of Vasomag) in / m or IV once a day for 10 days, then 500 mg orally. The general course of treatment is 4-6 weeks.

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

    Ophthalmology (hemophthalmia and hemorrhage into the retina of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (including diabetic and hypertensive))

    For 50 mg (0.5 ml of Vasomag) is parabulbar for 10 days. Including used in combination therapy.

    Mental and physical overloads

    For 500 mg (5 ml of Vasomag) in / m or iv once a day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.

    Chronic alcoholism

    For 500 mg (5 ml of Vasomag) in / m or iv twice a day. The course of treatment is 7-10 days.

    Side effects:

    Rarely - allergic reactions (redness, rash, itching, swelling) and dyspepsia, tachycardia, decreased or increased blood pressure, arousal.

    Rarely - eosinophilia, general weakness.

    Overdose:

    Cases of overdose are not established. The drug is low in toxicity and does not cause side effects, which are dangerous for the health of patients.

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

    Treatment: symptomatic.

    Interaction:

    Do not use simultaneously with other medicines containing meldoon (risk of aggravation of side effects).

    Strengthens the coronarodilating and hypotensive drugs, cardiac glycosides.

    Due to the possible development of moderate tachycardia and hypotension, caution should be exercised when combined with nitroglycerin,nifedipine, alpha-adrenoblockers, other antihypertensive drugs and peripheral vasodilators.

    You can combine with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmic drugs, diuretics, bronchodilators.

    Special instructions:

    Many years of experience in the treatment of acute myocardial infarction and unstable angina in cardiac units shows that the meldonia dihydrate is not I series preparation in acute coronary syndrome and its use is not an urgent need.

    Meldonium is included in the Prohibited List of Substances of the World Anti-Doping Code.

    Effect on the ability to drive transp. cf. and fur:

    There are no data on the adverse effect of the drug on the ability to drive vehicles.

    Form release / dosage:

    Solution for injection, 100 mg / ml.

    Packaging:

    5 ml of the drug into neutral glass ampoules.

    10 ampoules per contour cell pack of polyvinylchloride film.

    On 1 contour acheikova packing together with the instruction on application place in a pack from a cardboard.

    Storage conditions:

    At a temperature of no higher than 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:LP-000578
    Date of registration:02.09.2011 / 07.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Olainfarm, AOOlainfarm, AO Latvia
    Manufacturer: & nbsp
    Representation: & nbspOLAINFARM JSC OLAINFARM JSC Latvia
    Information update date: & nbsp05.02.2017
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