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

In conditions of increased load meldoon restores the balance between delivery and the need for cells in oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; has also a tonic effect. As a result of its use, the body acquires the ability to withstand the load and quickly restore energy reserves. Thanks to these properties meldoon used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to enhance physical and mental performance.As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is synthesized intensively. In the case of acute ischemic injury of the myocardium meldoon 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. With acute and chronic ischemic impairment of cerebral circulation, meldonium

improves blood circulation in the source of ischemia, promotes redistribution of blood in favor of the ischemic site. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.

Pharmacokinetics:

After intravenous administration, the bioavailability is 100%. The maximum concentration of the drug in the blood plasma (Cmah) is achieved immediately after its introduction. 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:

- As part of complex therapy:

· ischemic heart disease (angina pectoris, myocardial infarction), chronic heart failure and cardiomyopathy against a background of dyshormonal disorders;

· acute and chronic disorders of blood supply to the brain (stroke, cerebrovascular insufficiency);

- hemophthalmia and hemorrhage into the retina of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (including diabetic and hypertensive);

- reduced performance, mental and physical overload (including athletes). The drug may give a positive result in doping control (see section "Special instructions");

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

Contraindications:

- Hypersensitivity to the drug;

- pregnancy and the period of breastfeeding;

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

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

Carefully:

In diseases of the liver and / or kidney.

Pregnancy and lactation:

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

Isolation of the drug meldoon with milk and its effect on the health of the newborn have not been studied. If you need to use the drug 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.

Meldonium is administered intravenously, intramuscularly, parabulbar. 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:

- ischemic heart disease (myocardial infarction) intravenously struino by 0.5-1 g per day (5-10 ml of the drug);

- ischemic heart disease (stable angina); chronic heart failure and cardiomyopathy against a background of dyshormonal disorders intravenously struino by 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 10-14 days with the subsequent transition to taking the drug inside.The general course of treatment is 4-6 weeks.

Violation of cerebral circulation

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

With chronic cerebral circulatory insufficiency (dyscirculatory encephalopathy), 0.5 g (5 ml of the drug) intramuscularly or intravenously once a day for 10 days, followed by a transition to oral intake of 0.5 g. 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 and hypertonic).

To 0.05 g (0.5 ml of the preparation) is parabulbar for 10 days. Including used in combination therapy.

Mental and physical overloads

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

Chronic alcoholism

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

Side effects:

Classification of adverse reactions according to the frequency of development according to the recommendations of the World Health Organization: very often (≥10%), often (≥ 1% and <10%), infrequently (≥ 0.1% and <1%), rarely (≥ 0, 01% and <0.1%), very rarely (<0.01%), including individual messages, the frequency is unknown - can not be determined from available data.

Rarely - allergic reactions (redness, rashes, itching, swelling), as well as dyspeptic phenomena, tachycardia, a decrease or increase in blood pressure, agitation.

Very rarely - eosinophilia, general weakness.

Overdose:

Symptoms: lowering of arterial pressure, accompanied by headache, tachycardia, dizziness, general weakness.

Treatment: symptomatic.

Meldonium is low in toxicity and does not cause undesirable reactions, which are dangerous for the health of patients.

Interaction:

Strengthens the action of cardiac glycosides.

You can combine with 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 combined with nitroglycerin,nifedipine, alpha-adrenoblockers, other antihypertensive drugs and peripheral vasodilators. meldoon strengthens their action.

Special instructions:

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

From 1 January 2016 meldoon is included in the list of banned substances of the World Anti-Doping Agency.

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

There is no evidence of adverse effects of the drug on the rate of psychomotor reactions.

Form release / dosage:

Solution for injection 100 mg / ml.

Packaging:

By 5 ml in ampoules of neutral glass grade HC-3 or imported colorless (NK) glass of the 1 st hydrolytic class.

5 or 10 ampoules are placed in a contour mesh package made of a polyvinyl chloride film.

1 circuit cell pack of 10 ampoules or 2 contour packs of 5 ampoules with instructions for use are placed in a pack of cardboard. In the pack, a scarifier is attached.

When you pack the ampoules with a break ring or notch and the point the ampoule scaper is not put.

Storage conditions:

In the dark place 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-004294

Date of registration:16.05.2017

Expiration Date:16.05.2022

The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia

Manufacturer: & nbsp

Company DEKO, LLC Russia

Information update date: & nbsp17.06.2017

Illustrated instructions

Instructions

Meldonij DECO (Meldonium-DEKO)