Mildronate capsules 500 mg, 60 pcs. (meldonium)

Latin name

Mildronate

Release form

Hard gelatin capsules, size No. 00, white colored capsule contents - white crystalline powder with a slight odor, hygroscopic.



packaging 10 pcs - blister packs (6) - packs of cardboard

Pharmacological action

A drug that improves tissue metabolism and energy supply. Meldonium dihydrate is a synthetic analogue of gamma-butyrobetaine, a substance that is found in every cell in the human body.

The mechanism of action determines the diversity of its pharmacological effects: increased efficiency, decreased symptoms of mental and physical stress, activation of tissue and humoral immunity, cardioprotective effect.

Inhibits gamma-butyrobetaine hydroxy kinase, reduces carnitine synthesis and transport of long chain fatty acids through cell membranes, prevents the accumulation of activated forms of non-oxidized fatty acids in the cells - acyl carnitine derivatives and acyl coenzyme A. Under conditions of ischemia, meldonium restores the balance between the processes of oxygen delivery and consumption prevents the violation of the transport of ATP at the same time activates glycolysis, which proceeds without additional oxygen consumption. As a result of a decrease in carnitine concentration, gamma-butyrobetaine with vasodilating properties is intensely synthesized.

Has a cardioprotective effect, normalizes myocardial metabolism. In acute ischemic myocardial damage, meldonium slows the formation of the necrotic zone, shortens the rehabilitation period. In heart failure, the drug increases myocardial contractility, increases exercise tolerance, and reduces the frequency of angina attacks.

In acute and chronic ischemic disorders of cerebral circulation, improves blood circulation in the focus of ischemia, promotes redistribution of blood in favor of the ischemic site.

Effective with vascular and dystrophic fundus pathology.

It has a tonic effect on the central nervous system, eliminates functional disorders of the somatic and autonomic nervous system in patients with chronic alcoholism with withdrawal syndrome.

Pharmacokinetics

Absorption

After oral administration of meldonium, dihydrate is rapidly absorbed from the digestive tract. Bioavailability is 78%. Cmax in the blood plasma is achieved 1-2 hours after ingestion.

Metabolism and excretion

Metabolized mainly in the liver with the formation of two major metabolites that are excreted by the kidneys. T1 / 2 for oral administration is 3-6 hours and depends on the dose.

Indications

as part of the complex treatment of coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure,

dishormonal cardiomyopathy as part of the complex therapy of subacute and chronic cerebrovascular disorders (stroke and cerebrovascular insufficiency) .

Contraindications

Hypersensitivity to the active substance and other components of the drug, increased intracranial pressure (with impaired venous outflow, intracranial tumors), age up to 18 years (efficacy and safety have not been established), pregnancy, lactation period.

Precautions:

for liver and / or kidney disease.

Use during pregnancy and lactation

The safety of the drug during pregnancy has not been established.

To avoid possible adverse effects on the fetus, Mildronate should not be prescribed during pregnancy.

It is not known whether meldonium dihydrate is excreted in breast milk.

If it is necessary to use the drug Mildronate during lactation, breast-feeding should be discontinued.

Composition

1 caps.

meldonium dihydrate 500 mg

Excipients:

potato starch - 27.2 mg,

silicon dioxide colloidal - 10.8 mg,

calcium stearate - 5.4 mg.

Composition of the capsule shell:

titanium dioxide (E171) - 2%,

gelatin - 98%.

Dosage and administration of

Due to the possibility of developing an exciting effect, the drug is recommended to be used in the morning and no later than 17.00 (when taken several times a day).

In case of IHD (angina pectoris, myocardial infarction), chronic heart failure as part of complex therapy, the drug is prescribed orally at a dose of 0.5-1 g / day, the frequency of use is 1-2 times / day. The course of treatment is 4-6 weeks.

With dishormonal cardiomyopathy, Mildronate as part of complex therapy is prescribed orally at 500 mg / day. The course of treatment is 12 days.

In case of subacute cerebrovascular accidents (stroke and cerebrovascular insufficiency), after the end of the course of injection therapy with the drug Mildronate, they continue to be taken as a part of complex therapy inside for 0.5-1 g / day, applying the entire dose once or dividing it into 2 doses. The course of treatment is 4-6 weeks.

In case of chronic cerebrovascular accident, the drug is taken as part of complex therapy inside of 0.5 g / day. The general course of therapy is 4-6 weeks. Repeated courses are possible after consultation with a doctor (usually 2-3 times a year).

With reduced working capacity, mental and physical stress (including among athletes), 500 mg is prescribed orally 2 times / day. The course of treatment is 10-14 days. If necessary, therapy is repeated after 2-3 weeks.

Athletes are recommended to use 0.5-1 g 2 times / day before training. The duration of the course in the preparatory period is 14-21 days, during the competition period - 10-14 days.

With withdrawal symptoms in chronic alcoholism (in combination with a specific therapy for alcoholism), the drug is prescribed orally 500 mg 4 times / day. The course of treatment is 7-10 days.

Side effects

Rarely, allergic reactions (redness and itching of the skin, skin rash, urticaria, angioedema), as well as dyspeptic symptoms, tachycardia, decreased or increased blood pressure, increased irritability.

Very rarely - eosinophilia, general weakness.

Drug Interaction

Mildronate enhances the action of coronary artery, some antihypertensive drugs, cardiac glycosides.

Mildronate can be combined with prolonged forms of nitrates, other antianginal drugs, anticoagulants and antiplatelet agents, antiarrhythmic agents, diuretic and bronchodilator drugs.

Due to 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 forms of nifedipine).

Overdose

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

Treatment: carrying out symptomatic therapy.

Storage conditions

At a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Expiration

4 years.

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

Deystvuyuschee substances

meldonium

dosage form

dosage form

capsules

Grindeks, Latvia



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