Mildovel solution for injection 100mg/ml 5ml ampoules, 10pcs

Composition

Per 1 ml:

Active ingredient: meldonium dihydrate (trimethylhydrazinium propionate dihydrate – – 100.0 mg.

Auxiliary substance: water for injection.

Pharmacological action

Pharmacotherapeutic group: metabolic agent

ATX Code: C01EB

Pharmacological properties

Pharmacodynamics

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

Under conditions of increased stress, meldonium restores the balance between the delivery and demand of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; it also has a tonic effect. As a result of its application, the body acquires the ability to withstand the load and quickly restore energy reserves. Due to these properties, meldonium is used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to increase physical and mental performance. As a result of a decrease in the carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized.

In the case of acute ischemic myocardial injury, meldonium slows down the formation of the 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 the cerebral circulation, meldonium improves blood circulation in the focus of ischemia, promotes blood redistribution in favor of the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal symptoms.

Pharmacokinetics

After intravenous use, the bioavailability is 100%. The maximum concentration of the drug in blood plasma (Cmax) is reached immediately after its use.

It is metabolized in the body with the formation of two main metabolites, which are excreted by the kidneys. The elimination half-life is 3-6 hours.

Trace concentrations of meldonium remain in the body for a long time.

Indications

Pharmacotherapeutic group: metabolic agent

ATX Code: C01EB

Pharmacological properties

Pharmacodynamics

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

Under conditions of increased stress, meldonium restores the balance between the delivery and demand of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; it also has a tonic effect. As a result of its application, the body acquires the ability to withstand the load and quickly restore energy reserves. Due to these properties, meldonium is used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to increase physical and mental performance. As a result of a decrease in the carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized.

In the case of acute ischemic myocardial injury, meldonium slows down the formation of the 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 the cerebral circulation, meldonium improves blood circulation in the focus of ischemia, promotes blood redistribution in favor of the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal symptoms.

Pharmacokinetics

After intravenous use, the bioavailability is 100%. The maximum concentration of the drug in blood plasma (Cmax) is reached immediately after its use.

It is metabolized in the body with the formation of two main metabolites, which are excreted by the kidneys. The elimination half-life is 3-6 hours.

Trace concentrations of meldonium remain in the body for a long time.

Use during pregnancy and lactation

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

Isolation of the drug with milk and its effect on the health of the newborn have not been studied. If it is necessary to use the drug, stop breastfeeding.

Contraindications

-hypersensitivity to the components of the drug;

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

– pregnancy and lactation;

– age up to 18 years (efficacy and safety have not been established).

With caution

For liver and/or kidney diseases.

Side effects

Classification of adverse reactions by frequency according to the World Health Organization recommendations: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (

Immune system disorders

Rare: skin rash, angioedema.

Nervous system disorders Rare: psychomotor agitation.

Disorders of the heart and blood vessels

Rarely: tachycardia, low or high blood pressure.

Gastrointestinal disorders are rare: dyspeptic disorders.

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

Laboratory and instrumental data Very rare: eosinophilia.

Interaction

Enhances the action of cardiac glycosides.

It can be combined with antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmic drugs, diuretics, bronchodilators.

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

How to take, course of use and dosage

Due to the possible development of an excitatory effect, it is recommended to use the drug in the first half of the day.

The drug is administered intravenously, intramuscularly, parabulbar. The method of use, dose and duration of treatment are set individually, depending on the indications, severity of the condition, etc.

Cardiovascular diseases

As part of complex therapy: coronary heart disease (myocardial infarction) intravenously jet 0.5-1 g per day (5-10 ml of the drug); coronary heart disease (stable angina); chronic heart failure and cardiomyopathy against the background of dishormonal disorders intravenously jet 0.5-1 g per day (5-10 ml of the drug) or intramuscularly 0.5 g 1-2 times a day. The course of treatment is 10-14 days, followed by switching to oral use of the drug. The general course of treatment is 4-6 weeks.

Impaired cerebral circulation

As part of complex therapy in the acute phase,0.5 g (5 ml of the drug) once a day intravenously for 10 days, followed by switching to oral use of 0.5-1 g. The general course of treatment is 4-6 weeks.

For chronic cerebrovascular insufficiency (dyscirculatory encephalopathy),0.5 g (5 ml of the drug) intramuscularly or intravenously 1 time a day for 10 days, followed by switching to taking the drug inside 0.5 g. The general course of treatment is 4-6 weeks.

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

Ophthalmology

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

0.05 g (0.5 ml of the drug) parabulbarno for 10 days. It is also used in combination therapy.

Mental and physical overload

0.5 g (5 ml of the drug) intramuscularly or intravenously 1 time a day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.

Chronic alcoholism

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

Overdose

Symptoms

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

Treatment

Treatment is symptomatic.

Meldonium is low-toxic and does not cause adverse reactions that are dangerous to the health of patients.

Description

Clear, colorless liquid.

Special instructions

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

Since January 1,2016, meldonium has been included in the World Anti-Doping Agency’s list of banned substances.

Influence on the ability to drive vehicles and mechanisms

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

Storage conditions

In a place protected from light at a temperature of no more than 25 degrees. Keep out of reach of children.

Shelf life

3 years

Do not use after the expiration date.

Active ingredient

Meldonium

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection