Mildronate solution for injection 100mg / ml, 5ml No. 10

• in the complex therapy of ischemic heart disease (angina pectoris, myocardial infarction);

• chronic heart failure;

• dyshormonal cardiomyopathy;

• in the complex therapy of acute and chronic disorders of the blood supply to the brain (stroke and cerebrovascular insufficiency);

• hemophthalmos and retinal hemorrhages of various etiologies;

• thrombosis of the central retinal vein and its branches;

• retinopathy of various etiologies (diabetic, hypertensive);

• reduced performance;

• mental and physical stress (including in athletes);

• withdrawal syndrome in chronic alcoholism (in combination with specific therapy for alcoholism).

• In view of the possible development of an exciting effect, it is recommended to use it in the first half of the day.

  MildronateЃ is prescribed i / m, i / v and parabulbar. The route of administration, doses and duration of the course of treatment are set individually, depending on the indications, the severity of the condition and other factors.

  In case of ischemic heart disease (myocardial infarction), as part of complex therapy, the drug is prescribed intravenously in a stream at 0.5-1.0 g / day (5-10 ml of MildronateЃ), applying the entire dose at once or dividing it into 2 injections.

  In case of ischemic heart disease (stable angina pectoris), chronic heart failure and dyshormonal cardiomyopathy, as part of complex therapy, the drug is prescribed intravenously in a stream at 0.5-1.0 g / day (5-10 ml of MildronateЃ), applying the entire dose at once or dividing it into 2 injections , or intramuscularly 0.5 g 1-2 times / day, the course of treatment is 10-14 days, followed by a switch to taking the drug inside. The general course of treatment is 4-6 weeks.

  As part of the complex therapy of cerebral circulation disorders in the acute phase, the drug is prescribed at 0: 5 g (5 ml of MildronateЃ) 1 time / day intravenously for 10 days, followed by switching to oral administration for 0.5-1 g. General course treatment - 4-6 weeks.

  In chronic cerebral circulatory insufficiency (discirculatory encephalopathy) , 0.5 g (5 ml of MildronateЃ) is prescribed intramuscularly or intravenously 1 time / day for 10 days, then 0.5 g orally. The general course of treatment is 4-6 weeks. Repeated courses (usually 2-3 times a year) are possible after consulting a doctor.

  For hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic, hypertensive) , 0.05 g (0.5 ml of MildronateЃ) is prescribed parabulbar for 10 days. Incl. used in combination therapy.

  In case of mental and physical stress, the drug is administered at 0.5 g (5 ml of MildronateЃ) intramuscularly or intravenously 1 time / day. The course of treatment is 10-14 days. If necessary, repeat the treatment after 2-3 weeks.

  In chronic alcoholism , 0.5 g (5 ml of MildronateЃ) is prescribed intramuscularly or intravenously 2 times / day. The course of treatment is 7-10 days.

Solution for intramuscular, intravenous and parabulbar administration is transparent, colorless.

1 ml 1 amp. meldonium dihydrate 100 mg, 500 mg in 5 ml

Excipients : water d / i.

5 ml - ampoules of colorless glass (5) - cell plastic packaging (2) - cardboard packs.
5 ml - ampoules of colorless glass (5) - cell plastic packaging (4) - cardboard packs.

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

• age up to 18 years (efficacy and safety have not been established);

• pregnancy;

• lactation period;

• hypersensitivity to the components of the drug.

With caution: in case of liver and / or kidney diseases.

Release form, packaging and composition of the drug MildronateЃ

Solution for intramuscular, intravenous and parabulbar administration is transparent, colorless.

1 ml 1 amp. meldonium dihydrate 100 mg, 500 mg in 5 ml

Excipients : water d / i.

5 ml - ampoules of colorless glass (5) - cell plastic packaging (2) - cardboard packs.
5 ml - ampoules of colorless glass (5) - cell plastic packaging (4) - cardboard packs.

Clinical and pharmacological group: Metabolic drug

Pharmaco-therapeutic group: Metabolic agent

pharmachologic effect

Meldonium is a structural analogue of gamma-butyrobetaine, a substance that is found in every cell of the human body.

Under conditions of increased load, MildronateЃ 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; also has a tonic effect. As a result of its use, the body acquires the ability to withstand stress and quickly restore energy reserves. Due to these properties, MildronateЃ 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 concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized.

In the case of acute ischemic damage to the myocardium, MildronateЃ slows down the formation of a necrotic zone, shortens the rehabilitation period. In case of 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, MildronateЃ improves blood circulation in the ischemic focus, 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

Absorption and distribution

The bioavailability of the drug after intravenous administration is 100%. Cmax in blood plasma is reached immediately after its administration.

Metabolism and excretion

It is metabolized in the body with the formation of two main metabolites, which are excreted by the kidneys. T1 / 2 is 3-6 hours.

Indications of the drug MildronateЃ

• in the complex therapy of ischemic heart disease (angina pectoris, myocardial infarction);

• chronic heart failure;

• dyshormonal cardiomyopathy;

• in the complex therapy of acute and chronic disorders of the blood supply to the brain (stroke and cerebrovascular insufficiency);

• hemophthalmos and retinal hemorrhages of various etiologies;

• thrombosis of the central retinal vein and its branches;

• retinopathy of various etiologies (diabetic, hypertensive);

• reduced performance;

• mental and physical stress (including in athletes);

• withdrawal syndrome in chronic alcoholism (in combination with specific therapy for alcoholism).

  Dosage regimen

  In view of the possible development of an exciting effect, it is recommended to use it in the first half of the day.

  MildronateЃ is prescribed i / m, i / v and parabulbar. The route of administration, doses and duration of the course of treatment are set individually, depending on the indications, the severity of the condition and other factors.

  In case of ischemic heart disease (myocardial infarction), as part of complex therapy, the drug is prescribed intravenously in a stream at 0.5-1.0 g / day (5-10 ml of MildronateЃ), applying the entire dose at once or dividing it into 2 injections.

  In case of ischemic heart disease (stable angina pectoris), chronic heart failure and dyshormonal cardiomyopathy, as part of complex therapy, the drug is prescribed intravenously in a stream at 0.5-1.0 g / day (5-10 ml of MildronateЃ), applying the entire dose at once or dividing it into 2 injections , or intramuscularly 0.5 g 1-2 times / day, the course of treatment is 10-14 days, followed by a switch to taking the drug inside. The general course of treatment is 4-6 weeks.

  As part of the complex therapy of cerebral circulation disorders in the acute phase, the drug is prescribed at 0: 5 g (5 ml of MildronateЃ) 1 time / day intravenously for 10 days, followed by switching to oral administration for 0.5-1 g. General course treatment - 4-6 weeks.

  In chronic cerebral circulatory insufficiency (discirculatory encephalopathy) , 0.5 g (5 ml of MildronateЃ) is prescribed intramuscularly or intravenously 1 time / day for 10 days, then 0.5 g orally. The general course of treatment is 4-6 weeks. Repeated courses (usually 2-3 times a year) are possible after consulting a doctor.

  For hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic, hypertensive) , 0.05 g (0.5 ml of MildronateЃ) is prescribed parabulbar for 10 days. Incl. used in combination therapy.

  In case of mental and physical stress, the drug is administered at 0.5 g (5 ml of MildronateЃ) intramuscularly or intravenously 1 time / day. The course of treatment is 10-14 days. If necessary, repeat the treatment after 2-3 weeks.

  In chronic alcoholism , 0.5 g (5 ml of MildronateЃ) is prescribed intramuscularly or intravenously 2 times / day. The course of treatment is 7-10 days.

  Side effect

  Depending on the frequency of occurrence, the following groups of unwanted adverse reactions according to WHO are distinguished: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000 and <1/1000), very rare (<1/10 000), the frequency is unknown (the frequency cannot be estimated from the available data).

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

  From the side of the cardiovascular system: rarely - tachycardia, decrease or increase in blood pressure.

  From the digestive system: rarely - dyspeptic symptoms.

  Others: rarely - excitement; very rarely - eosinophilia, general weakness.

  Contraindications for use

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

  • age up to 18 years (efficacy and safety have not been established);

  • pregnancy;

  • lactation period;

  • hypersensitivity to the components of the drug.

  With caution: in case of liver and / or kidney diseases.

  Application during pregnancy and lactation

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

  The excretion of MildronateЃ in breast milk and its effect on the health of the newborn have not been studied. If necessary, the use of the drug during lactation should stop breastfeeding.

  Application for violations of liver function

  The drug should be prescribed with caution for liver diseases.

  Application for impaired renal function

  With caution, the drug should be prescribed for kidney disease.

  Application in children

  Contraindicated in patients under the age of 18, because efficacy and safety have not been established.

  special instructions

  Many years of experience in the treatment of acute myocardial infarction and unstable angina pectoris in cardiology departments shows that MildronateЃ is not a first-line drug for acute coronary syndrome and its use is not urgently needed.

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

  Influence on the ability to drive vehicles and mechanisms

  There is no data on the adverse effect of MildronateЃ on the speed of the psychomotor reaction.

  Overdose

  MildronateЃ is low-toxic and does not cause adverse reactions hazardous to the health of patients.

  Symptoms: a decrease in blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.

  Treatment: carrying out symptomatic therapy.

  Drug interactions

  MildronateЃ can be combined with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators.

  The drug enhances the action of cardiac glycosides.

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

  Storage conditions of the drug MildronateЃ

  The drug should be stored out of the reach of children at a temperature not exceeding 25 ? C; do not freeze.

  Shelf life of the drug MildronateЃ

  The shelf life is 5 years. Do not use after the expiration date printed on the package.

  Terms of sale

  The drug is available with a prescription.