Active substanceMeldoneyMeldoney
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  • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    Active substance:

    Meldonium dihydrate
    in terms of dihydrate without adsorbed moisture - 100 mg; in terms of anhydrous substance - 80.2 mg.

    Excipient:

    Water for injection up to 1 ml.
    Description:Transparent 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:

    Synthetic analogue of gamma-butyrobetaine, suppresses gamma-butyrobetaine hydroxynase. Under conditions of ischemia, it restores the balance of the processes of oxygen delivery and its consumption in cells. The mechanism of action determines the diversity of its pharmacological effects: increase ability to work, reducing the symptoms of mental and physical overstrain, the activation of tissue and humoral immunity.

    Cardioprotective action: in case of acute ischemic damage to the myocardium, slows the formation of the necrotic zone, shortens the rehabilitation period.With heart failure increases myocardial contractility, increases tolerance to physical activity, reduces frequency 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 chronic alcoholism with withdrawal syndrome.

    Pharmacokinetics:

    After intravenous administration, the maximum concentration of the drug (CmOh) in the blood plasma is achieved immediately after its administration. There are no data on the bioavailability of the drug after intramuscular injection. 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:

    - Reduced performance, increased physical activity, postoperative period to accelerate rehabilitation.

    - In the complex therapy of coronary heart disease, chronic heart failure; cardialgia against the background of dyshormonal myocardial dystrophy.

    - As part of complex therapy for disorders of cerebral circulation (cerebral blood flow disorders of the ischemic type, especially the acute phase, chronic cerebral circulatory insufficiency).

    - Complex therapy of abstinence alcohol syndrome.

    - Acute circulatory disorders in the retina, 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).

    Contraindications:

    Hypersensitivity, increased intracranial pressure (with violation of venous outflow and intracranial tumors), pregnancy, lactation.

    Not applicable in children under 18 due to lack of data.

    Carefully:

    Chronic liver and kidney disease.

    Pregnancy and lactation:

    The safety of the drug during pregnancy is not proven. To avoid possible adverse effects on the fetus, do not prescribe the drug during pregnancy.

    It is not known whether the drug is excreted in breast milk.If you need to use the drug Melfor® during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Increased mental and physical activity: intravenously, 500 mg (5 ml) once a day. The course of treatment is 10-14 days. If necessary, repeat the course after 2-3 weeks. In cardiovascular diseases (as part of complex therapy): intravenously, 500-1000 mg (5-10 ml) of injection solution. The course of treatment is 10-14 days.

    Violation of the cerebral circulation of the ischemic type, especially the acute phase (as part of a combination therapy): intravenously 500 mg (5 ml) once a day for 7-10 days, then switch to oral administration.

    Chronic insufficiency of cerebral circulation: intramuscularly 500 mg (5 ml) once a day. The course of treatment - 10-14 days, then switch to oral intake. An abstinent alcoholic syndrome: intravenously - on 500 mg (5 ml) 2 times a day. The course of treatment is 7-10 days.

    Vascular pathology of the fundus and retinal dystrophy: 50 mg (0.5 ml) of injection solution are administered retrobulbarno and subconjunctivally for 10 days.

    Side effects:

    Rarely - allergic reactions (redness, skin rash, itching, swelling), dyspepsia, tachycardia, decrease or increase in blood pressure, agitation.

    Very rarely - eosinophilia, general weakness.

    Overdose:

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

    Treatment: symptomatic.

    Interaction:

    Strengthens the coronary arthritis and some antihypertensive medications, cardiac glycosides. You can combine with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmic drugs, diuretics, bronchodilators. In view of the possible development of a moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-adrenoblockers, antihypertensive drugs and peripheral vasodilators.

    Special instructions:

    Melfor® is not a first-line drug in acute coronary syndrome and its use is not an urgent need.

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

    There is no evidence of the unfavorable effect of Melfor® on the reaction rate.

    Form release / dosage:Solution for injection 100 mg / ml.
    Packaging:

    5 ml into neutral glass ampoules.

    5 ampoules per contour cell pack.

    For 1 or 2 contour mesh packages (with foil or without foil), along with instructions for the use of the drug, a knife or scarifier ampoule in a pack of cardboard. When packing ampoules with rings or break points, knives or scarifier ampoules do not.

    For 20, 50 or 100 contour cell packs with foil, together with 20, 50 or 100 instructions for the use of the drug, respectively, with knives or ampoule scalers placed in a box of cardboard or in a box of corrugated cardboard (for inpatient).

    When packing ampoules with rings or break points, knives or scarifier ampoules do not.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001664
    Date of registration:19.04.2012 / 30.11.2012
    The owner of the registration certificate:AVISTA, LLC AVISTA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.03.2016
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