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

Structural analogue of gamma-butyrobetaine - a substance that is present in every cell of the human body. Meldoney inhibits gamma-butyrobetaine hydroxylase, reduces the synthesis of carnitine and transport of long chain fatty acids through the cell membranes, prevents the accumulation of activated forms of unoxidized fatty acids - acylcarnitine and acylcoenzyme A in cells. Under conditions of ischemia, it restores the equilibrium of oxygen delivery and consumption in cells, adenosine triphosphate (ATP). Simultaneously, 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 variety of pharmacological effects of meldonia: increasing efficiency, reducing the symptoms of mental and physical overstrain, the activation of tissue and humoral immunity, cardioprotective action. In the case of acute ischemic damage, the myocardium slows the formation of the necrotic zone, shortens the rehabilitation period. With heart failure increases myocardial contractility, increases exercise tolerance, reduces the incidence of angina attacks. In acute and chronic ischemic disorders of cerebral circulation improves blood circulation in the ischemic focus, promotes redistribution of blood in favor of the ischemic site. Effective in the case of vascular and dystrophic pathology of the fundus. Characteristic is also a tonic effect on the central nervous system, the elimination of functional disorders of somatic and autonomic nervous systems in patients with alcoholism during the period of abstinence.

Pharmacokinetics:

With intravenous administration, bioavailability is 100%. The maximum concentration in the blood plasma 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 is 3-6 hours.

Indications:

- in the complex therapy of coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure; dyshormonal cardiomyopathy;

- in the complex therapy of cerebral circulation disorders (ischemic stroke, cerebrovascular insufficiency);

- reduced working capacity; mental and physical overload (including athletes);

- syndrome of withdrawal from chronic alcoholism (in combination with specific therapy);

- hemophthalmia and hemorrhages in the retina of the eye of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertonic).

Contraindications:

- hypersensitivity to the components of the drug;

- increased intracranial pressure (with violation of venous outflow and intracranial tumors);

- pregnancy, lactation;

- age to 18 years (efficacy and safety not established).

Carefully:

Chronic liver and / or kidney disease.

Long-term experience in the treatment of myocardial infarction and unstable angina in the cardiology departments shows that meldoon is not a first-line drug in acute coronary syndrome and its use is not an urgent need.

Pregnancy and lactation:

The safety of the drug during pregnancy is not proven. To avoid possible adverse effects on the fetus, do not prescribe the drug during pregnancy.

It is not known whether the drug is excreted in breast milk. If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Intravenously, parabulbar.

In connection with the possibility of developing an exciting effect, the drug is recommended for use in the first half of the day.

Cardiovascular diseases

As part of complex therapy, 0.5-1 g intravenously 1-2 times a day, treatment course 4-6 weeks.

Violation of cerebral circulation

In the acute phase, inject 0.5 g intravenously once a day for 10 days, then go to the inside, the course of treatment 4-6 weeks.

Mental and physical overloads

For 0.5 g intravenously once a day, the course of treatment 10-14 days, if necessary, the treatment is repeated after 2-3 weeks.

The syndrome of withdrawal from chronic alcoholism (in combination with specific therapy)

For 0.5 g intravenously 2 times a day. The course of treatment is 7-10 days.

Ophthalmology (hemophthalmia and hemorrhages in the retina of the eye of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertonic))

Enter parabulbarno in a dose of 0.5 ml for 10 days, including in the combination therapy.

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 (<1/10000), the frequency is unknown (can not be determined from available data).

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

From the central nervous system: rarely - psychomotor agitation.

From the digestive system: rarely - dyspeptic disorders.

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

Other: very rarely - general weakness.

Overdose:

Symptoms of drug overdose: lowering blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.

Treatment: symptomatic.

Interaction:

You can combine with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmics, diuretics, bronchodilators.

Strengthens the coronarodilating and hypotensive drugs, cardiac glycosides.

In view of the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, beta-blockers, other antihypertensive drugs and peripheral vasodilators, since meldoon strengthens their action.

Special instructions:

Effect on the ability to drive transp. cf. and fur:There are no data on the adverse effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities.

Form release / dosage:

Solution for intravenous and parabulbar injection 100 mg / ml.

Packaging:

For 5 ml of the drug in neutral glass ampoules.For 5 ampoules in a contour plastic packaging (pallet) or in a planar cell pack.

1, 2 contour plastic packages (pallets) or contour mesh packages together with the instruction for use and a vial ampoule or scarifier ampoule in a pack of cardboard.

5, 10 ampoules together with the instruction for use and a knife ampoule or scarifier ampoule in a pack with a separating insert of cardboard.

If you use ampoules with a colored break point and a notch or a colored break ring, the ampoule knife or ampoule ampoule opener is not inserted.

Packing for hospitals

10, 20 contour plastic packages (pallets) or contour mesh packages together with an equal number of instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze.

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-002463

Date of registration:13.05.2014 / 25.01.2017

The owner of the registration certificate:BINERGIYA, CJSC BINERGIYA, CJSC Russia

Manufacturer: & nbsp

Armavir Biofactory, FKP

Information update date: & nbsp16.03.2016

Illustrated instructions

Instructions

Meldonium-Binergia (Meldonium-Binergia)