Meldonium - instructions for use, dose, side effects, contraindications

Analogue of gamma-butyrobetaine, suppresses gamma-butyrobetaine hydroxynase, reduces synthesis of carnitine and transport of long chain fatty acids through cell membranes, prevents the accumulation of activated forms of unoxidized fatty acids - acylcarnitine and acylcoenzyme A in cells. Under conditions of ischemia, the equilibrium of oxygen delivery and consumption in cells, prevents disruption of the transport of adenosine triphosphate (ATP); At the same time it activates glycolysis, which proceeds without additional consumption of oxygen.As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is synthesized intensively. The mechanism of action determines the diversity of its pharmacological effects: increasing efficiency, reducing the symptoms of mental and physical stress, activation of tissue and humoral immunity, cardioprotective effect. In the case of acute ischemic damage, the myocardium slows the formation of the necrotic zone, shortens the rehabilitation period. With heart failure (CH) increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral blood circulation improves blood circulation in the ischemic focus, promotes redistribution of blood to the ischemic area. Effective in the case of vascular and dystrophic pathology of the main bottom. It is also characteristic tonic effect on the central nervous system (CNS), the elimination of functional disturbances of somatic and autonomic nervous system in patients with chronic alcoholism during abstinence.

Pharmacokinetics:

With intravenous administration, bioavailability is 100%. The maximum concentration of the drug in plasma (C_max) is achieved immediately after administration. Metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life period depends on the dose, is 3-6 hours.

Indications:

Reduced performance, physical overexertion (including athletes).

As part of complex therapy:

- ischemic heart disease (IHD) (angina pectoris, myocardial infarction), chronic heart failure (CHF), cardialgia against dyshormonal cardiomyopathy.

- disorders of cerebral circulation (ischemic stroke, cerebrovascular insufficiency).

- hemophthalmia and hemorrhages in the retina of various etiologies, thrombosis of the central vein of the retina and ce branches, retinopathy of various etiologies (including diabetic and hypertensive).

Abstinence alcohol syndrome (in combination with specific therapy).

Contraindications:

Hypersensitivity to the drug, increased intracranial pressure (with violation of venous outflow and intracranial tumors), pregnancy, lactation,age under 18 years due to lack of data on efficiency and safety.

Carefully:

Chronic liver and / or kidney disease.

Pregnancy and lactation:

Safety of use in pregnant women ns has been studied, therefore, to avoid possible adverse effects on the fetus, its use is contraindicated. Isolation of the drug Meldoney with milk and its effect on the state of health of the newborn have not been studied, therefore, if necessary, use should stop breastfeeding.

Dosing and Administration:

In view of the possible development of an exciting effect, it is recommended to apply the drug in the morning.

Parabulbarno, intravenously (intravenously), intramuscularly (in / m). The method of administration, dose and duration of treatment are set individually, depending on the indications, the severity of the condition, etc.

Cardiovascular diseases

As part of complex therapy:

- with ischemic heart disease (myocardial infarction) - in / in struyno 500-1000 mg per day (5-10 ml of the drug Meldoney), applying the whole dose at once or dividing it into 2 injections;

- with ischemic heart disease (stable angina); chronic heart failure and dyshormonal cardiomyopathy - in / in jet for 500-1000 mg per day (5-10 ml of the drug Meldoney), applying the whole dose at once or dividing it into 2 injections, or in / m 500 mg 1-2 times a day, the course of treatment 10-14 days, with a subsequent transition to oral administration. The general course of treatment is 4-6 weeks.

Disorders of cerebral circulation

In the complex therapy in the acute phase - 500 mg (5 ml of the drug Meldoney) 1 time per day IV for 10 days, switching to oral administration at 500-1000 mg. The general course of treatment is 4-6 weeks.

With chronic insufficiency of cerebral circulation (dyscirculatory encephalopathy) - 500 mg (5 ml of the drug Meldoney) in / m or iv once a day for 10 days, then 500 mg orally.

The general course of treatment is 4-6 weeks.

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

Ophthalmology (hemophthalmia and hemorrhage into the retina of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertonic).

For 50 mg (0.5 ml of the drug Meldoney) parabulbarically for 10 days. Including used in combination therapy.

Mental and physical overloads

For 500 mg (5 ml of the drug Meldoney) in / m or iv once a day. The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.

Chronic alcoholism

For 500 mg (5 ml of the drug Meldoney) in / m or iv twice a day. The course of treatment is 7-10 days.

Side effects:

The frequency of adverse reactions is determined by the following categories:

Very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10 000, <1/1000), very rarely (<1/10 000).

From the cardiovascular system: rarely - tachycardia, decrease or increase in blood pressure (BP).

From the central nervous system: rarely - psychomotor agitation.

From the digestive system: rarely - dyspeptic disorders.

Allergic reactions: rare skin itching, redness of the skin, skin rash, angioedema; very rarely - eosinophilia.

Other: very rarely - general weakness.

Overdose:

Symptoms: lowering blood pressure, headache, tachycardia, dizziness, general weakness.

Treatment: symptomatic.

Interaction:

Strengthens the coronarodilating and some hypotensive drugs (LS), cardiac glycosides. You can combine antianginal drugs, anticoagulants, antiaggregants, antiarrhythmic drugs, diuretics, bronchodilators. In view of the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combining e with nitroglycerin, nifedipine, alpha-adrenoblockers,hypotensive drugs and peripheral vasodilators.

Special instructions:

Meldonium is not a 1-line drug in acute coronary syndrome and its use is not strictly necessary.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of adverse effects of the drug Meldoney on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Solution for parabulbar, intravenous and intramuscular injection, 100 mg / ml.

Packaging:

By 5 ml into ampoules of neutral glass or from glass of the 1 st hydrolytic class.

5 ampoules are placed in a contiguous cell pack of a polyvinylchloride (PVC) film or a polyethylene terephthalate (PET) film.

1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard for consumer containers.

5 or 10 ampoules together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard with a corrugated liner.

When packing ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

Packing for hospitals. 4, 5 or 10 contour mesh packages together with instructions for use in an amount equal to the number of contour mesh packages are placed in a pack of cardboard for consumer containers.

50 or 100 contour mesh packages, together with instructions for use in an amount equal to the number of contour mesh packages, are placed in a box of corrugated cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003176

Date of registration:07.09.2015 / 05.07.2017

Expiration Date:07.09.2020

The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia

Manufacturer: & nbsp

ELLARA, LTD. Russia

Information update date: & nbsp23.04.2018

Illustrated instructions

Instructions

Meldoney (Meldonium)