MILDRONATE (Meldonium)

Instructions for MILDRONATE

Latin name MILDRONATE:

MILDRONATE

Active substance MILDRONATE:

Meldonium

Release form MILDRONATE

solution for intravenous, intramuscular and parabulbar administration

Owner / Registrar
GRINDEX, AO

Indications MILDRONATE:

• Withdrawal state
• Transient transient cerebral ischemic attacks [attacks] and related syndromes
• Retinal vascular occlusions
• Background retinopathy and retinal vascular changes
• Retinal hemorrhage
• Diabetic retinopathy (E10-E14 + with common fourth character .3)
• Other diseases of the eyeball
• Angina pectoris [angina pectoris]
• Acute myocardial infarction
• Cardiomyopathy in metabolic disorders
• Improves blood circulation in the brain, has a tonic effect
• Congestive heart failure
• Intracerebral hemorrhage
• Brain infarction
• Consequences of cerebrovascular diseases
• Overwork
• Stress, not elsewhere classified
• Hemophthalmos and retinal hemorrhages of various etiologies.
• Thrombosis of the central vein and retina and its branches
• Retinopathy of various etiologies, diabetic, hypertensive

Pharmacological group MILDRONATE:

Metabolic drug

pharmachologic effect MILDRONATE:

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

In high load conditions Mildronat ® restores the balance between the delivery and demand of cells in oxygen, eliminates the accumulation of toxic products of metabolism in the 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, Mildronate ® 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 case of acute ischemic myocardial injury, Mildronate ® slows down the formation of the 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, Mildronate ® 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 MILDRONATE:

Absorption and distribution
The bioavailability of the drug after intravenous administration is 100%. C max 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. T 1/2 is 3-6 hours.
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.

Overdose MILDRONATE:

MILDRONATE is low-toxic and does not cause side effects hazardous to the health of patients.
Symptoms: a decrease in blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.
Treatment: symptomatic therapy.

Special instructions MILDRONATE:

Many years of experience in the treatment of acute myocardial infarction and unstable angina pectoris in cardiology departments shows that Mildronate ® is not a first-line drug in 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 Mildronate ® on the speed of the psychomotor reaction.

With renal failure
With caution, the drug should be prescribed for kidney disease.
In case of liver dysfunction
The drug should be prescribed with caution for liver 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 MILDRONATE in breast milk and its effect on the health of the newborn have not been studied. If necessary, use of the drug during lactation should stop breastfeeding.

Drug interactions MILDRONATE:

MILDRONATE can be combined with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators.
The drug enhances the action of cardiac glycosides.
In view of the possible development of moderate tachycardia and arterial hypotension, care should be taken when combined with nitroglycerin, nifedipine, alpha-blockers, other antihypertensive drugs and peripheral vasodilators, because Mildronate ® enhances their effect.

How to take MILDRONATE:

In view of the possible development of a stimulating effect, it is recommended to use it in the morning.

MILDRONATE is prescribed intramuscularly, intravenously and parabulbarno. 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.

When CHD (myocardial infarction) composed of combination drug therapy prescribed in / jet of 0.5-1.0 g / d (5.10 ml preparation Mildronate ® ), applying the entire dose at once or by dividing it into 2 administration.

In CAD (stable angina), congestive heart failure and cardiomyopathy dyshormonal in the complex therapy drug administered in / jet of 0.5-1.0 g / d (5.10 ml Mildronate ® ), applying the entire dose at once or by dividing it into 2 administration , or in / m 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 cerebrovascular accidents in the acute phase, the drug is prescribed at 0 : 5 g (5 ml of Mildronate ® ) 1 time / day intravenously for 10 days, followed by switching to oral administration of 0.5-1 g. General course treatment - 4-6 weeks.
In chronic cerebral circulatory insufficiency (discirculatory encephalopathy) , 0.5 g (5 ml of Mildronate ® ) 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 Mildronate ® ) are prescribed parabulbar for 10 days. The drug is used in combination therapy.
In case of mental and physical stress, the drug is administered at 0.5 g (5 ml of Mildronate ® ) intramuscularly or intravenously 1 time / day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.
In chronic alcoholism , 0.5 g (5 ml of Mildronate ® ) is prescribed intramuscularly or intravenously 2 times / day. The course of treatment is 7-10 days.