Meldonium instructions for use and why. What is meldonium? The effect of meldonium on the human body. Meldonium - the principle of action

Meldonium is the active ingredient of the popular drug mildronate (it will be written about separately here), which is also an independent drug produced by the domestic pharmaceutical plant Pharmstandard. Meldonium triggers at the cellular level a whole cascade of pharmacologically significant reactions, interactions and transformations that affect cellular metabolism and allow the use of this drug both in the "solo" mode and as part of combination therapy in such seemingly completely unrelated areas, as the treatment of cardiovascular and eye diseases, the treatment of withdrawal symptoms and the correction of asthenic conditions. The mechanism of action of this drug is unlikely to be fully understood by a person uninitiated in biochemical mysteries: meldonium inhibits the enzyme gamma-butyrobetaine hydroxygenase, which is involved in the synthesis of carnitine, resulting in an increase in the production of gamma-butyrobetaine, which has vasodilating properties. But this is not all the advantages of meldonium: it inhibits the movement of long-chain fatty acids through the cell membrane, actively counteracts the presence and multiplication in cells of active forms of unoxidized fatty acids, which are derivatives of acyl coenzyme A and acyl carnitine. And if for the time being most readers are not yet very clear what is the use of all this, then you should be a little patient and continue reading. One of the main clinically significant effects of meldonium is the correction of the disturbed balance between oxygen delivery to cells and its consumption under adverse conditions of ischemia (the Great Soviet Encyclopedia gives a very apt and clear definition of this pathological condition - local anemia).

The drug prevents the violation of the transport of the main energy substrate of the cell - ATP, while simultaneously activating anaerobic glycolysis with this good deed. With ischemia of the heart muscle, meldonium slows down the formation of the necrosis zone, shortens the rehabilitation period. In case of insufficiency of the function of the heart, it increases the contractility of the heart muscle, endows the patient with the ability to endure more impressive physical exertion, and reduces the frequency of angina pectoris. At the level of self-awareness, meldonium increases efficiency, tones up the central nervous system, activates the immune system, relieves physical and mental overstrain.

Meldonium is available in the form of capsules and solution for injection. The oral dosage form is taken before meals. The dose, frequency and duration of administration are determined by a specific disease and can vary over a fairly wide range: for example, the duration of meldonium intake in heart failure, stable angina pectoris or cerebrovascular accident is 4-6 weeks, with cardialgia - 12 days, with alcohol withdrawal - 7- 10 days, with reduced performance and as an aid in sports - 10-21 days.

Pharmacology

Means that improves metabolism, an analogue of gamma-butyrobetaine. Suppresses gamma-butyrobetaine hydroxynase, inhibits the synthesis of carnitine and the transport of long-chain fatty acids through cell membranes, prevents the accumulation in cells of activated forms of unoxidized fatty acids - derivatives of acylcarnitine and acylcoenzyme A.

Under conditions of ischemia, it restores the balance of the processes of oxygen delivery and its consumption in cells, prevents the violation of ATP transport; at the same time, it activates glycolysis, which proceeds without additional oxygen consumption. As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized. The mechanism of action determines the diversity of its pharmacological effects: increased efficiency, reduced symptoms of mental and physical overstrain, activation of tissue and humoral immunity, cardioprotective effect.

In the case of acute ischemic myocardial damage, it slows down the formation of a necrotic zone, shortens the rehabilitation period. In heart failure, it increases myocardial contractility, increases exercise tolerance, and reduces the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral circulation, it improves blood circulation in the focus of ischemia, promotes the redistribution of blood in favor of the ischemic area. Effective in vascular and dystrophic pathology of the fundus. It has a tonic effect on the central nervous system, eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 78%. C max in plasma is achieved 1-2 hours after administration. Biotransformed in the body with the formation of two main metabolites, which are excreted by the kidneys. T 1/2 is 3-6 hours and depends on the dose.

Release form

5 ml - ampoules (5) - plastic cell packaging (1) - cardboard packs.
5 ml - ampoules (10) - plastic blister packs (1) - cardboard packs.
5 ml - ampoules (5) - plastic blister packs (2) - cardboard packs.
5 ml - ampoules (5) - plastic cell packaging (15) - cardboard packs.
5 ml - ampoules (5) - plastic cell packaging (20) - cardboard packs.

Dosage

In connection with the possibility of developing an exciting effect, it is recommended to use it in the morning. The dose is set individually depending on the indications and route of administration.

When taken orally, a single dose is 0.25-1 g, the frequency of administration and the duration of treatment depend on the indications.

When administered intravenously, the dose is 0.5-1 g 1 time / day, the duration of treatment depends on the indications.

Parabulbarno enter 0.5 ml of injection with a concentration of 500 mg / 5 ml for 10 days.

Interaction

When used together, meldonium enhances the effect of antianginal drugs, some antihypertensive drugs, and cardiac glycosides.

With the simultaneous use of meldonium with nitroglycerin, nifedipine, alpha-blockers, antihypertensive agents and peripheral vasodilators, moderate tachycardia, arterial hypotension may develop (with these combinations, caution is required).

Side effects

Since the cardiovascular system: rarely - tachycardia, changes in blood pressure.

From the side of the central nervous system: rarely - psychomotor agitation.

From the digestive system: rarely - dyspeptic symptoms.

Allergic reactions: rarely - itching, redness, rash, swelling.

Indications

For oral or intravenous administration: as part of complex therapy for coronary artery disease (angina pectoris, myocardial infarction), chronic heart failure, dyshormonal cardiomyopathy; as part of the complex therapy of acute and chronic disorders of cerebral circulation (strokes and cerebrovascular insufficiency); decreased performance, physical overstrain (including in athletes), postoperative period to speed up rehabilitation; withdrawal syndrome in chronic alcoholism (in combination with specific alcoholism therapy).

For parabulbar administration: acute circulatory disorders in the retina, hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (including diabetic and hypertensive) - only for parabulbar administration.

Contraindications

Increased intracranial pressure (including in violation of venous outflow, intracranial tumors), pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age, hypersensitivity to meldonium.

Application features

Use during pregnancy and lactation

During pregnancy and lactation (breastfeeding), the use of the drug is contraindicated.

Application for violations of liver function

Application for violations of kidney function

Use with caution in kidney disease, especially for a long time.

Use in children

In children and adolescents under the age of 18, the efficacy and safety of meldonium has not been established.

Meldonium in the form of capsules is contraindicated for use in children and adolescents under the age of 18; in the form of syrup - in children under the age of 12 years.

special instructions

Use with caution in diseases of the liver and / or kidneys, especially for a long time.

Many years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments shows that meldonium is not a first-line drug in acute coronary syndrome.

Formula: C6H14N2O2, chemical name: 3-(2,2,2-trimethylhydrazinium) propionate (monohydrate).
Pharmacological group: metabolites / other metabolites.
Pharmachologic effect: cardioprotective, metabolic, antianginal, adaptogenic, antihypoxic, improves cerebral circulation.

Pharmacological properties

Meldonium is a structural synthetic analog of gamma-butyrobetaine (precursor of carnitine). Meldonium inhibits gamma-butyrobetaine hydroxylase, reduces the transport of long-chain fatty acids through cell membranes and the production of carnitine. Meldonium prevents the cellular accumulation of active forms of non-oxidized fatty acids (including acylcarnitine, which blocks the delivery of adenosine triphosphate to cell structures). Meldonium improves metabolic processes. Activates glycolysis and prevents a violation of the transport of adenosine triphosphate during ischemia. By reducing the production of carnitine, meldonium increases the content of gamma-butyrobetaine, which has a vasodilatory effect. Meldonium in acute myocardial infarction shortens the rehabilitation period, slows down tissue necrosis. In chronic and acute disorders of cerebral circulation, it improves blood circulation in the ischemic focus, participating in the redistribution of blood flow to ischemic areas. In heart failure, it increases exercise tolerance, improves contractility of the heart muscle. Meldonium increases humoral and cellular immunity. In chronic alcoholism, it eliminates the withdrawal syndrome. Reduces the symptoms of physical and mental overstrain, increases efficiency, improves endurance. With an increased load, meldonium eliminates the accumulation of toxic metabolic products in cells, protects cells from damage, restores the balance between the need and delivery of oxygen to cells, and also has a tonic effect.
After oral administration, meldonium is well absorbed in the gastrointestinal tract. Bioavailability is approximately 78% (with intravenous administration - 100%). The maximum concentration is reached in 1 - 2 hours (with intravenous administration - immediately). Meldonium is metabolized in the body, with the formation of two main metabolites, which are excreted by the kidneys. The half-life is 3-6 hours.

Indications

Physical overstrain, including in athletes; reduced performance; to speed up rehabilitation in the postoperative period.
As part of complex treatment - chronic heart failure, coronary heart disease (myocardial infarction, angina pectoris), cardialgia with dyshormonal myocardial dystrophy, chronic and acute disorders of cerebral circulation (cerebrovascular insufficiency, stroke).
In ophthalmology - thrombosis of the central retinal vein and its branches, hemorrhages in the retina and hemophthalmia of various origins, retinopathy of various origins (hypertensive, diabetic) - only for parabulbar administration.
Withdrawal syndrome in chronic alcoholism (together with specific treatment).

Method of application of meldonium and doses

Meldonium is taken orally, administered intramuscularly, intravenously, parabulbarno. Doses, route of administration, duration of therapy are set individually depending on the indications, the severity of the condition and other factors. For adults, the average doses are: when taken orally - 2-4 times a day, 250 mg, parabulbarno - 50 mg per day, parenterally - 500 mg per day.
Athletes are prescribed according to special schemes along with other drugs.
In acute coronary syndrome, meldonium is not a first-line drug and its use is not urgently needed.
Due to the possibility of developing an exciting effect, meldonium is recommended to be taken in the morning.

Contraindications for use

Hypersensitivity, lactation period, pregnancy, increased intracranial pressure (with intracranial tumors, impaired venous outflow), age up to 18 years (safety and effectiveness of use have not been established).

Application restrictions

Impaired liver and/or kidney function.

Use during pregnancy and lactation

The use of meldonium is contraindicated in pregnancy, as the safety of using the drug in pregnant women has not been studied. At the time of therapy with meldonium, breastfeeding should be stopped.

Meldonium side effects

Dyspepsia, agitation, tachycardia, allergic reactions (drying, redness, itching, swelling), decrease or increase in blood pressure, eosinophilia, general weakness.

Interaction of meldonium with other substances

Caution is required when using meldonium with nifedipine, nitroglycerin, alpha-blockers, antihypertensive drugs, peripheral vasodilators, since meldonium enhances their effect. Meldonium is compatible with anticoagulants, antianginal agents, antiplatelet agents, bronchodilators, antiarrhythmics, diuretics. Meldonium enhances the action of cardiac glycosides.

Overdose

With an overdose of meldonium, hypotension, headache, tachycardia, dizziness, and general weakness develop. Symptomatic treatment is necessary.

Thank you

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!

Names, forms of release, composition and dosage of Mildronate

The composition of all three dosage forms of Mildronate includes the same active substance - meldonium. This active ingredient is also called mildronate or trimethylhydrazinium propionate dihydrate. In some instructions for use attached to the drug, the name of the active substance (INN) is meldonium, in others - mildronate, and in the third - trimethylhydrazinium propionate dihydrate. However, in all cases we are talking about the same chemical substance, which is indicated by different names.

Mildronate capsules contain gelatin, titanium dioxide, silicon dioxide, calcium stearate and potato starch as excipients. The solution for injection does not contain any excipients, since it contains only meldonium and purified water. Mildronate syrup contains the following excipients:

• Methyl parahydroxybenzoate;
• Propyl parahydroxybenzoate;
• propylene glycol;
• Glycerol;
• Citric acid monohydrate;
• cherry essence;
• Allura Red dye (E129);
• Dye Brilliant Black BN (E151);

Mildronate capsules are often called pills. However, since the drug does not have such a dosage form, the term "tablets" means a variety of Mildronate for oral administration, and these are capsules. Therefore, in this case, capsules = tablets. To indicate the required dosage of capsules, short names are usually used, such as Mildronate 250 And Mildronate 500, where the number corresponds to the dose of the active substance. To refer to a solution for injection in everyday life, short forms of names are often used, such as Mildronate injections And Mildronate ampoules.

Therapeutic action of Mildronate

• Cardioprotective action – protection of heart cells from negative influences and improvement of their viability;
• Antianginal action - a decrease in the oxygen demand of myocardial cells (due to this effect, even a small amount of oxygen supplied under ischemia is enough for myocardial cells, which reduces the severity of pain, reduces the frequency of angina attacks and increases the tolerance of physical and emotional stress);
• Antihypoxic action - reducing the negative impact of oxygen deficiency;
• Angioprotective action - protection and ensuring the integrity of the walls of blood vessels;
• Tonic action.

Mildronate injection solution is available in one concentration of 100 ml / ml and is intended for intravenous, intramuscular or parabulbar administration. That is, the same solution is used for any type of injection.

Ampoules with a solution should be opened immediately before the injection. Do not store open solution either outdoors or in the refrigerator. If the ampoule with the solution was opened in advance and stood for more than 20 minutes, then such a drug cannot be used, it should be discarded and a new ampoule opened.

Before opening the ampoule, carefully inspect the solution for cloudiness, flakes and other inclusions. If there are any, then the solution cannot be used. For injection, only a clear and completely transparent solution can be used.

Injections must be done in the morning, since Mildronate has a stimulating effect. If you need to make several injections per day, then the last of them should be made at least 4 to 5 hours before going to bed.

Intramuscular injections can be done independently at home, and intravenous and parabulbar injections can only be done in a clinic or hospital. Intravenous injections at home can only be given by a qualified nurse.

Dosages and rules for the introduction of Mildronate intramuscularly and intravenously

So, if you need the drug to act quickly and the effect occurs within a short period of time, then the solution is administered intravenously. This is usually necessary in acute conditions. If it is necessary to ensure a long-term effect of the drug with a not very rapid development of the clinical effect, then the solution is administered intramuscularly. This is usually justified in the treatment of chronic conditions. Thus, it can be briefly summarized that intravenous injections are used in acute conditions, and intramuscular injections in the treatment of chronic diseases. Parabulbar injections are used only in the treatment of eye diseases.

The standard dosage of solutions for intravenous and intramuscular injections is 500 mg per day (5 ml of solution), and for parabulbar ones - 50 mg per day (0.5 ml). However, these dosages may vary depending on the severity of the person's condition and the type of disease for which the drug is used. Consider the dosage, frequency and duration of intravenous and intramuscular injections of Mildronate for various diseases and conditions.

For unstable angina or myocardial infarction Mildronate should be administered intravenously at 500-1000 mg (5-10 ml of solution) per day. This dosage can be administered at one time or divided into two. That is, if a person does not tolerate injections well, then it is better to administer the entire daily dosage of 500-1000 mg at once. If a person normally tolerates intravenous injections, then it is better to divide the daily dosage equally into 2 parts and inject a solution of 250-500 mg twice a day.

Injections are required only for one day, after which the person can be transferred to receive Mildronate in the form of tablets or syrup. However, if for some reason a person cannot take pills or syrup, or their effectiveness will be low due to diseases of the digestive tract, then the further course of treatment is continued with intramuscular injections. In this case, within 4-6 weeks, 500-1000 mg per day is already administered intramuscularly every 3 days. The daily dose can also be administered at one time or divided into two.

With chronic heart failure Mildronate is administered intravenously at 500-1000 mg (5-10 ml of solution) 1 time per day or intramuscularly at 500 mg (5 ml of solution) 2 times per day for 10-14 days. After completing the course of intravenous or intramuscular injections, they switch to taking Mildronate in the form of tablets or syrup for another 3 to 4 weeks.

In the acute period of cerebrovascular accident Mildronate is administered intravenously at 500 mg (5 ml) once a day for 10 days. After that, the person is transferred to taking the drug in the form of tablets or syrup, or to intramuscular injections. Intramuscular injections are made at 500 mg (5 ml of solution) once a day for 2 to 3 weeks.

With chronic disorders of cerebral circulation Mildronate can be taken in the form of tablets or administered intramuscularly. In such cases, the choice of the method of using the drug (taking pills or intramuscular injections) is determined by the personal preferences of the person, as well as his objective condition and the body's ability to absorb drugs when taken orally. For example, if a person cannot swallow tablets, or they are poorly absorbed due to diseases of the digestive tract, then he should prefer intramuscular injections. If there are no obstacles to taking the pills, then it is better to choose this particular method of using the drug.

So, in chronic disorders of cerebral circulation, it is necessary to inject 500 mg (5 ml of solution) of Mildronate intramuscularly 1 time per day for 2 to 3 weeks. The course of therapy can be repeated 2-3 times a year.

With pain in the heart against the background of dyshormonal myocardial dystrophy Mildronate is administered intravenously at 500 - 1000 mg (5 - 10 ml of solution) 1 time per day, or intramuscularly at 500 mg (5 ml of solution) 2 times a day for 10 - 14 days. With incomplete disappearance of pain after the completion of the course of injections of Mildronate, the drug is prescribed in tablets for another 12 days.

With mental and physical overload or to speed up rehabilitation after surgery Mildronate can be administered intravenously, intramuscularly, or taken as tablets. The choice of method of administration is based on the same criteria as for chronic cerebrovascular accidents. Intravenously or intramuscularly, Mildronate is administered at 500 mg (5 ml of solution) 1-2 times a day for 10-14 days. If necessary, the course of therapy is repeated after 2 to 3 weeks.

With chronic alcoholism Mildronate is administered intravenously for severe lesions of the nervous system. In this case, 500 mg (5 ml of solution) is administered 2 times a day for 7 to 10 days.

With pathology of the vessels of the fundus or retinal dystrophy Mildronate is administered parabulbarno 500 mg (5 ml of solution) once a day for 10 days. In the presence of an inflammatory process in the eyes, Mildronate is combined with intravenous or also parabulbar administration of corticosteroid hormones (Prednisolone, Dexamethasone, Betamethasone, etc.). And with retinal dystrophy, it is rational to combine Mildronate with the use of drugs that improve microcirculation.

special instructions

People suffering from chronic diseases of the liver and kidneys, with prolonged use of Mildronate, should periodically monitor the functioning of these organs.

In myocardial infarction, Mildronate is not a first-line drug, the use of which is mandatory for the effective treatment of an acute condition.

The inclusion of Mildronate in the complex therapy of patients suffering from chronic heart failure increases their tolerance to physical and emotional stress.

In clinical studies, it was found that Mildronate reduces the concentration of atherogenic lipid fractions ("bad cholesterol") in the blood.

Since there are no scientifically confirmed data on the safety of Mildronate for children, it is recommended to refrain from using this drug in children under 12 years of age.

Influence on the ability to control mechanisms

Overdose

• Decreased blood pressure;
• Tachycardia (palpitations);
• General weakness.

Interaction with other drugs

Mildronate is well combined and improves the severity of the clinical effect of the following drugs:

• Antianginal agents (Sustak, Nitrong, Betaloc, Kordanum, Trental, Dipyridamole, Riboxin, etc.);
• Anticoagulants (Warfarin, Thrombostop, etc.);
• Antiplatelet agents (Prostacycline, Aspirin Cardio);
• Antiarrhythmic drugs (Adenocor, Amiodarone, Bretilat, Difenin, Kordaron, Moratsizin, Propanorm, Ritalmex, Rhythmiodarone, etc.);
• Diuretic drugs (Veroshpiron, Diakarb, Furosemide, etc.);
• Bronchodilators (Ventolin, Berotek, etc.).

• Increased intracranial pressure (against the background of impaired venous outflow or in the presence of intracranial tumors);
• Pregnancy and breastfeeding (due to lack of evidence of complete safety);
• Hypersensitivity or allergic reactions to the components of tablets, syrup or solution;
• Age under 12 years old.

Some instructions for use indicate that Mildronate is contraindicated for children under 18 years of age, however, such terms are reinsurance on the part of the drug manufacturer.

Meldonium - analogues

Analogues of Mildronate in the domestic pharmaceutical market are two groups of drugs - synonyms and actual analogues. Synonyms are called drugs containing, like Mildronate, meldonium as an active substance. Analogues are drugs that have similar therapeutic effects, but contain different active substances.

Synonyms of Mildronate are the following drugs:

• Angiocardil solution for injection;
• Vasomag capsules and solution for injection;
• Idrinol solution for injection;
• Cardionate capsules and injection;
• Meldonium capsules and injection;
• Midolat capsules;
• Mildrakor injection solution (only in Ukraine);
• Mildrocard capsules (only in Belarus);
• Melfor capsules;
• Medatern capsules.

Analogues of Mildronate are the following drugs:

• Angiosil retard tablets;
• Antisten and Antisten MB tablets;
• Biosint lyophilisate for solution for injection;
• Bravadin tablets;
• Valeocor-Q10 tablets;
• Vero-Trimetazidine tablets;
• Gistochrome solution for injections;
• Deprenorm MB tablets;
• Dibikor tablets;
• Dinaton solution for injection;
• Doppelherz Cardiovital tablets;
• Ezafosfin lyophilizate and ready solution;
• Inosie-F and Inosin-Eskom solution for injection;
• Carditrim tablets;
• Koraksan tablets;
• corona pellets;
• Kudevita capsules;
• Kudesan drops;
• Medarum 20 and Medarum MB tablets;
• Mexicor capsules and injection;
• Metaguard tablets;
• Sodium adenosine triphosphate (ATP) solution for injection;
• Neoton lyophilisate for solution for injection;
• Orocamag capsules;
• Pedea solution for injection;
• Predizin tablets;
• Preductal and Preductal MB tablets;
• precard tablets;
• Ranex tablets;
• Riboxin capsules, tablets and injection;
• Rimecor and Rimecor MV tablets;
• Taufon tablets;
• Triducard tablets;
• Trimectal capsules;
• Trimectal MB tablets;
• Trimet tablets;
• Trimetazid tablets and capsules;
• Trimetazidine and Trimetazidine MB tablets;
• Trimitard MV tablets;
• Ubinon capsules;
• Firazir solution for injection;
• Fosfaden tablets and solution for injection;
• Ethoxydol tablets.

Mildronate - reviews

Almost all reviews of Mildronate are positive, due to the effectiveness of the drug in improving the functioning of the cardiovascular system. The entire set of positive reviews can be divided into two groups - concerning the use of the drug in severe chronic diseases and the use of the drug for functional disorders or overloads.

So, in positive reviews regarding the use of the drug for serious illnesses, people indicate that they took or periodically take Mildronate for vegetative-vascular dystonia, hypertension, heart failure or angina pectoris. With vegetative-vascular dystonia, Mildronate for 3-5 months completely normalized the condition of a person who practically forgot about his illness for this period. When the symptoms of dystonia reappear, people take a course of Mildronate and are satisfied with the result.

With hypertension, angina pectoris and heart failure, Mildronate is taken as part of complex therapy. In the reviews, people who took Mildronate for these diseases noted that the drug relieves fatigue, eliminates shortness of breath, a feeling of weakness, hopelessness and apathy, reduces the frequency of angina attacks, increases the overall endurance of the body and the tolerance of physical and emotional stress.

People who took Mildronate for functional disorders of the cardiovascular system (for example, low blood pressure, pain in the heart due to stress or high loads, darkening before the eyes when moving from a sitting to standing position, etc.), note in the reviews, that the drug quickly and completely eliminated their problem, instead of weakness and fatigue, lightness, energy, vigor, clarity in the head and a desire to live appeared.

Many reviews note that Mildronate helped to cope with high mental and physical stress, increasing efficiency and speeding up recovery after work. Athletes note that when using Mildronate, it becomes much easier to breathe during aerobic training and endurance increases significantly.

Negative reviews about Mildronate are literally single and they are usually associated with the development of a side effect that was poorly tolerated by a person, and therefore forced to stop using the drug.

one capsule contains: active substance: meldonium - 250 mg or 500 mg.

Excipients: magnesium stearate, potato starch, colloidal silicon dioxide.

The composition of the capsule shell: gelatin, glycerin, purified water, titanium dioxide, sodium lauryl sulfate.

Description

Capsules hard gelatin cylindrical shape with hemispherical ends of white color (for a dosage of 250 mg).

Capsules hard gelatin cylindrical shape with hemispherical ends of white color (for a dosage of 500 mg).

Pharmacotherapeutic group

Other drugs for the treatment of heart disease.

ATS code: C01EB22.

Indications for use

As part of combination therapy in the following cases:

Cardiovascular diseases - stable angina pectoris, chronic heart failure (NYHA I-III functional class), cardiomyopathy, functional disorders of the cardiovascular system; acute and chronic ischemic disorders of cerebral circulation; reduced performance, physical and psycho-emotional overload; the recovery period after cerebrovascular accidents, head injuries and encephalitis.

Dosage and administration

For internal use. Due to the possible tonic effect, it is recommended to use the drug in the morning.

Adults appoint 0.5- (2-4 capsules of 250 mg or 1-2 capsules of 500 mg) per day, using the entire dose at once or dividing it into 2 times. The maximum daily dose is.

The duration of the course of treatment is 4-6 weeks. Treatment courses can be repeated 2-3 times a year.

Precautionary measures

For patients with liver and/or kidney failure

it is necessary to reduce the dose of meldonium.

Elderly patients with liver and/or kidney failure the dose of meldonium must be reduced.

Children under the age of 18 meldonium is not used due to the lack of data on safety and efficacy.

Many years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments shows that meldonium is not a first-line drug in acute coronary syndrome.

Use during pregnancy or lactation

The safety of the drug during pregnancy has not been proven. To avoid possible adverse effects on the fetus, it is not prescribed during pregnancy.

In connection with the release of meldonium into mother's milk, in cases where the drug is used during lactation, breastfeeding should be discontinued.

Interaction with other drugs

The drug Meldonium-MIC can be used (together with long-acting nitrates and other antianginal agents, cardiac glycosides and diuretic drugs. It can also be combined with anticoagulants, antiplatelet agents, antiarrhythmic drugs and other drugs that improve microcirculation.

It should be borne in mind that Meldonium-MIC can enhance the effect of drugs containing glyceryl trinitrates, nifedipine, beta-blockers, other antihypertensive drugs and peripheral vasodilators.

Do not use together with other drugs containing meldonium, as the risk of side effects may increase.

Side effect

The drug is usually well tolerated. However, in sensitive patients, as well as in cases of overdose, side effects are possible.

The following side effects are classified according to the organ system groups and the frequency of occurrence of MedDRA: very often (> 1/10), often (> 1/100, 1/1000, 1/10 000 to

Blood and lymphatic system disorders

Not known: eosinophilia.

Immune System Disorders

Often: allergic reactions.

Cardiac disorders:

In some cases: tachycardia.

Circulatory system disorders

In some cases: low blood pressure.

Gastrointestinal disorders

Often: dyspepsia.

Nervous System Disorders

Often: headaches.

Not known: arousal.

Respiratory disorders, diseases of the chest and mediastinum

Not known: dyspnea.

General violations

Not known: general weakness.

Overdose

No cases of overdose have been reported. The drug is low toxic and does not cause severe side effects.

Symptoms: in case of low blood pressure, headaches, dizziness, tachycardia, general weakness are possible.

Treatment: symptomatic.

In case of severe overdose, it is necessary to monitor the functions of the liver and kidneys. Hemodialysis is not essential in case of an overdose of meldonium due to its pronounced protein binding.

Contraindications

hypersensitivity to meldonium or to any other component of the drug; increased intracranial pressure (in violation of venous outflow, intracranial tumors); hepatic or renal insufficiency (there is no sufficient data on the safety of use); During pregnancy and breastfeeding; children under 18 years of age (safety not tested).

Influence on the ability to drive vehicles and managemechanisms

Meldonium is a drug that will now be associated with scandals in sports.

At the same time, this is a drug that is prescribed not only for athletes with increased physical exertion, but also for people suffering from a lack of oxygen or ischemic pathologies.

In 2012, Russia included Meldonium in the list of vital means.

Reviews about the drug can be read at the end of the article.

Meldonium is an IB-class antiarrhythmic agent. It improves metabolism - metabolic processes in the human body.

It acts by suppressing gamma-butyrobetaine-hydroxynase, inhibiting the production of carnitine, which is called related to the B vitamin group, the transfer of acylcarnitine derivatives, acetylcoenzyme A.

Meldonium has the following effect:

• vasodilating;
• eliminates the symptoms of overstrain - both mental and physical;
• protects the heart
• increases myocardial contractility;
• tones the central nervous system;
• with alcoholism eliminates disturbances in the work of the central nervous system, if the patient has refused alcohol;
• protects the integrity of the walls of blood vessels;
• reduces the oxygen demand of myocardial cells;
• reduces the effects of oxygen starvation;
• stimulates tissue and humoral immunity, increases resistance to infections.

Indications

Meldonium, prescribed for myocardial infarction, inhibits the development of tissue necrosis in the heart, due to which the dying zone expands more slowly, and accelerates the patient's recovery.

The drug is well absorbed from the gastrointestinal tract if administered in oral dosage forms. The maximum concentration is observed 60-120 minutes after consumption.

Bioavailability is 78%. In the body, it breaks down into two metabolites, which are excreted by the kidneys.

The doctor prescribes Meldonium as part of a comprehensive treatment for such diseases:

• abstinence syndrome in those suffering from chronic alcoholism;
• rehabilitation after surgery;
• impaired cerebral circulation of acute and chronic forms as a result of strokes and cerebrovascular insufficiency;
• deterioration in working capacity, significant physical exertion, including in people involved in sports.

Meldonium is effective in eye diseases (parabulbar administration is prescribed):

• impaired blood flow of the retina in the acute phase;
• hemophthalmus, when blood penetrates into the vitreous body or into the surrounding space;
• the formation of blood clots in the central retinal vein or branching vessels;
• retinopathy, including those arising as a consequence of diabetes mellitus and hypertension.

Mode of application

Athletes are prescribed Meldonium in combination with other drugs according to an individual scheme. The same if the use of the remedy is caused by a disease. These daily doses have been established.

Patients after surgery, with overload, during the rehabilitation period: capsules inside 0.25 g 2 to 4 times, intramuscularly (in / m) - 0.5 g up to 2 times. Duration of therapy - from 10 to 14 days, therapy can be repeated after 14-21 days.

With stable angina, the first 3-4 days are prescribed 0.25 g 3 times. Then it is taken orally twice a week at a daily dosage of 0.25 g 3 times. The duration of therapy is from 4 to 6 weeks.

With unstable angina and myocardial infarction Meldonium is used intravenously in a jet way, 0.5 g or 1 g once a day. In the future, it is prescribed orally: 3-4 days - 0.25 g 2 times, then 2 days a week, 0.25 g 3 times a day.

With chronic heart failure the drug is administered intramuscularly by jet method once a day at a dose of 0.5-1 g or replaced by an intramuscular injection of 0.5 g up to 2 times a day. After 10–14 days of treatment, the patient is transferred to 0.5 g capsules, which he takes 1 time in the morning. The course of treatment is from 4 to 6 weeks.

With cardialgia, associated with dyshormonal myocardial dystrophy, the drug is administered intravenously by jet method 1 time per day, 0.5–1 g, or intramuscularly up to 2 times a day, 0.5 g each. After 10–14 days, an encapsulated form is prescribed at 0 25 mg in the morning and in the evening, treatment is continued for another 12 days.

With impaired cerebral circulation Meldonium is recommended during the period of exacerbation, 0.5 g once a day for 10 days, then in encapsulated form - 0.5 g daily for 14–21 days. In the chronic form of cerebral circulatory disorders, a course of treatment lasting 14–21 days is prescribed. The solution for injection is administered intramuscularly at 0.5 g 1 time per day or administered orally at 0.25 g (the frequency of administration depends on the severity of the patient's condition).

withdrawal syndrome requires a course of Meldonium therapy for 7-10 days. Then the patient is shown a four-time intake of the drug during the day, 0.5 g orally or twice - intravenously.

With vascular diseases of the fundus, retinal dystrophy Meldonium is prescribed retrobulbar and subconjunctival in a dose of 0.05 g for 10 days.

Since the drug causes excitation of the nervous system, it is advisable to take it no later than lunch.

Release form, composition

Meldonium is available in several dosage forms:

• solution for injection with a concentration of 100 mg / ml, ampoules 5 ml, in a package of 5 or 10 ampoules;
• solution for injection with a concentration of 500 mg / 5 ml, in a package from 5 to 100 ampoules;
• capsules 250, 500 mg in a blister, 3, 6 packs in a carton;
• syrup.

Interaction with other substances

Meldonium is carefully prescribed with vasodilators, antihypertensive agents, in particular, with nitroglycerin, alpha-blockers, nifedipine.

In such cases, the development of undesirable effects is likely - a clinically significant decrease in blood pressure, moderate tachycardia.

Meldonium potentiates the action of cardiac glycosides, as well as antianginal, some drugs to lower blood pressure.

Application features

Meldonium is characterized by good tolerance. However, there are some warnings about it.

Side effects

Meldonium usually has a mild effect on the body. But patients rarely developed such side effects:

In the heart and blood vessels	tachycardia (a symptom manifested in a heart rhythm disorder), changes in blood pressure.
In the central nervous system	psychomotor agitation.
In the digestive tract	symptoms of indigestion.
The immune system	allergic reactions, rash, swelling, redness of the skin.

Contraindications

Meldonium is not prescribed to the patient if he has increased intracranial pressure, including due to impaired venous outflow, intracranial neoplasms.