Mildovel, 100 mg/ml 5 ml 10 pcs

Pharmacotherapeutic group: metabolic agent

ATX code: C01EB

Pharmacological properties

Pharmacodynamics

Meldonium is a structural analog of γ-butyrobetaine, a substance found in every human cell.

Meldonium restores the balance between cellular oxygen supply and demand, eliminates the accumulation of toxic products of metabolism in cells, protecting them from damage; it also has a tonic effect. As a result of its use the body acquires the ability to withstand the load and quickly restore energy reserves. Meldonium is used for treating various cardiovascular, cerebral blood flow, and physical and mental performance disorders. The reduction of carnitine concentration results in the increased synthesis of γ-butyrobetaine, which has vasodilatory properties.

In case of acute ischemic myocardial damage, meldonium slows down the formation of the necrotic zone and shortens the rehabilitation period. In heart failure, it increases myocardial contractility, increases tolerance to physical load, and reduces the frequency of angina attacks. For acute and chronic ischemic disturbances of cerebral circulation Meldonium improves blood circulation in ischemic area, promotes redistribution of blood in favor of ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.

Pharmacokinetics

After intravenous administration the bioavailability is 100%. Maximum concentration of the drug in plasma (Cmax) is reached immediately after administration.

It is metabolized in the body to form two major metabolites, which are excreted by the kidneys. The elimination half-life is 3-6 hours.

The trace concentrations of meldonium persist in the body for a long time.

Indications

Pharmacotherapeutic group: metabolic agent

ATX code: C01EB

Pharmacological properties

Pharmacodynamics

Meldonium is a structural analog of γ-butyrobetaine, a substance found in every human cell.

Meldonium restores the balance between cellular oxygen supply and demand, eliminates the accumulation of toxic products of metabolism in cells, protecting them from damage; it also has a tonic effect. As a result of its use the body acquires the ability to withstand the load and quickly restore energy reserves. Meldonium is used for treating various cardiovascular, cerebral blood flow, and physical and mental performance disorders. The reduction of carnitine concentration results in the increased synthesis of γ-butyrobetaine, which has vasodilatory properties.

In case of acute ischemic myocardial damage, meldonium slows down the formation of the necrotic zone and shortens the rehabilitation period. In heart failure, it increases myocardial contractility, increases tolerance to physical load, and reduces the frequency of angina attacks. For acute and chronic ischemic disturbances of cerebral circulation Meldonium improves blood circulation in ischemic area, promotes redistribution of blood in favor of ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.

Pharmacokinetics

After intravenous administration the bioavailability is 100%. Maximum concentration of the drug in plasma (Cmax) is reached immediately after administration.

It is metabolized in the body to form two major metabolites, which are excreted by the kidneys. The elimination half-life is 3-6 hours.

The trace concentrations of meldonium persist in the body for a long time.

Active ingredient

How to take, the dosage

Because of the possible development of an excitatory effect, it is recommended to use the drug in the morning.

The drug is administered intravenously, intramuscularly, parabulbar. The method of administration, dosage and duration of treatment shall be determined individually, depending on the indication, severity of the condition, etc.

Cardiovascular diseases

In complex therapy: coronary heart disease (myocardial infarction) intravenously by jetting 0.5-1 g per day (5-10 ml of the drug); coronary heart disease (stable angina pectoris); chronic heart failure and cardiomyopathy on the background of dishormonal disorders intravenously by jetting 0.5-1 g per day (5-10 ml of the drug) or intramuscularly by 0.5 g 1-2 times a day. The course of treatment is 10-14 days with subsequent transition to oral administration. The total course of treatment is 4-6 weeks.

Brain circulation disorder

In combination therapy in acute phase by 0.5 g (5 ml of the preparation) once a day by intravenous injection for 10 days with subsequent change to oral administration of the preparation 0.5-1 g. The course of treatment during 4-6 weeks.

In chronic insufficiency of cerebral circulation (discirculatory encephalopathy) 0.5 g (5 ml of preparation) by intramuscular or intravenous injection once a day during 10 days with subsequent change to intravenous administration of 0.5 g. The total course of treatment is 4-6 weeks.

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

Ophthalmology

Hemophthalmia and retinal hemorrhages of various etiologies, central retinal vein thrombosis and its branches, retinopathy of various etiologies (diabetic and hypertensive).

In 0.05 g (0.5 ml of the drug) parabulbar for 10 days. It is also used as part of combined therapy.

Mental and physical overload

Please 0.5 g (5 ml of the drug) intramuscularly or intravenously once a day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.

Cronic alcoholism

0.5 g (5 ml of the drug) intramuscularly or intravenously 2 times a day. The course of treatment is 7-10 days.

Interaction

It enhances the effect of cardiac glycosides.

May be combined with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmic drugs, diuretics, bronchodilators.

Because of the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combining with nitroglycerin, nifedipine, α-adrenoblockers, other hypotensive drugs and peripheral vasodilators because meldonium increases their effect.

Special Instructions

Years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments show that meldonium is not a first-line drug for acute coronary syndrome and its use is not strictly necessary.

Meldonium has been on the World Anti-Doping Agency’s list of banned substances since January 1, 2016.

Influence on ability to drive and operate vehicles

There are no data on adverse effects of the drug on the speed of psychomotor reactions.

Synopsis

Contraindications

– hypersensitivity to the components of the drug;

– increased intracranial pressure (with impaired venous outflow, intracranial tumors);

– pregnancy and breastfeeding period;

– age under 18 years (effectiveness and safety are not established).

With caution

In case of liver and/or kidney disease.

Side effects

Classification of adverse reactions by frequency of occurrence according to World Health Organization recommendations: Very common (≥10%), common (≥1% and < 10%), infrequent (≥0.1% and < 1%), rare (≥0.01% and < 0.1%), very rare (< 0.01%), including individual reports, frequency unknown – cannot be determined from available data.

Immune system disorders

Rare: skin rash, angioedema.

Nervous system disorders Rare: psychomotor agitation.

Cardiovascular disorders

Rarely: tachycardia, decreased or increased blood pressure.

Gastrointestinal disorders Rare: dyspeptic disorders.

Skin and subcutaneous tissue disorders Rarely: skin itching, redness of the skin. General disorders and disorders at the site of administration Very rare: general weakness.

Laboratory and instrumental data Very rare: eosinophilia.

Overdose

Symptoms

Lower blood pressure accompanied by headache, tachycardia, dizziness, general weakness.

Treatment

The treatment is symptomatic.

Meldonium is mildly toxic and does not cause adverse reactions hazardous to patients.

Pregnancy use

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

The excretion of the drug in milk and its effect on the health of the newborn have not been studied. Breast-feeding should be stopped if the drug has to be used.

Similarities