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

In conditions of increased stress, MILDRON® 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. Due to these properties, MILDRON® is used to treat various disorders of the cardiovascular system, blood supply to the brain, and also to increase 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 myocardial damage to the myocardium MILDRONAT® 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 the cerebral circulation, MILDRONAT® improves blood circulation in the ischemic focus, 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:

Bioavailability of the drug after intravenous administration is 100%. The maximum concentration in the blood plasma is achieved immediately after its administration. Metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life (T1 / 2) is 3-6 hours.

Indications:

In the complex therapy of coronary heart disease (angina pectoris, myocardial infarction); chronic heart failure and dyshormonal cardiomyopathy, as well as in the complex therapy of acute and chronic disorders of blood supply to the brain (stroke and cerebrovascular insufficiency).

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

Reduced efficiency; mental and physical overload (including athletes).

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

Contraindications:

Hypersensitivity to the components of the drug, increased intracranial pressure (with violation of venous outflow, intracranial tumors), age to 18 years (efficacy and safety not established), pregnancy, lactation.

Carefully:

In diseases of the liver and / or kidney.

Pregnancy and lactation:

The safety of use in pregnant women has not been studied, therefore, to avoid possible adverse effects on the fetus, its use is contraindicated.The isolation of MILDRON® with milk and its effect on the health of the newborn have not been studied, therefore, if necessary, feeding.

Dosing and Administration:

In view of possible development stimulating effect, it is recommended to apply in the morning. MILDRONATE® is designated intramuscularly (in / m), intravenously (intravenously) and parabulbar. The mode of administration, dose and duration of treatment are set individually, depending on the indications, severity of the condition, etc.

Cardiovascular diseases

As part of complex therapy:

- ischemic heart disease (myocardial infarction) in / in jet 0.5-1.0 g per day (5-10 ml of MILDRON® preparation), applying the whole dose at once or dividing it into 2 injections;

- ischemic heart disease (stable angina); chronic heart failure and dyshormonal cardiomyopathy in / in jet 0.5-1.0 g per day (5-10 ml of the preparation MILDRONAT®), applying the entire dose at once or dividing it into 2 injections, or in / m 0.5 g 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.

Violation of cerebral circulation

As part of complex therapy in the acute phase of 0.5 g (5 ml of MILDRONAT®) once a day in the / in for 10 days, switching to oral intake of 0.5-1 g. The general course of treatment is 4-6 weeks. With chronic insufficiency of cerebral circulation (dyscirculatory encephalopathy) by 0.5 g (5 ml of MILDRONAT®) in / m or iv once a day for 10 days, then 0.5 g inwards. 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)).

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

Mental and physical overloads

0.5 g (5 ml of MILDRONAT®) 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 0.5 g (5 ml of MILDRONAT®) in / m or iv twice a day. The course of treatment is 7-10 days.

Side effects:

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 blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.

Treatment: symptomatic.

MILDRONATE® is low in toxicity and does not cause side effects that are dangerous to the health of patients.

Interaction:

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

Strengthens the action of cardiac glycosides.

In view of the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, other antihypertensive agents and peripheral vasodilators, since MILDRONAT® enhances their effect.

Special instructions:

Many years of experience in the management of acute myocardial infarction and unstable angina in cardiac units shows that MILDRONAT® is not I series preparation in acute coronary syndrome and its use is not an urgent need.

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

There is no evidence of adverse effects of MILDRONAT® on the rate of psychomotor response.

Form release / dosage:

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

Packaging:

For 5 ml in a vial of colorless glass with a line or break point.

By 5 ampoules in a cell box made of polyvinyl chloride film or from polyethylene terephthalate film without coating (pallet).

Two cell packs (pallet) together with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Do not freeze!

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N016028 / 02

Date of registration:20.05.2009 / 23.10.2014

The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia

Manufacturer: & nbsp

SANITAS, JSC Republic of Lithuania

ELFA PHARMACEUTICAL COMPANY, S.A. Poland

FARMSTANDART-UFAVITA, JSC Russia

Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia

Information update date: & nbsp10.03.2016

Illustrated instructions

Instructions

MILDRONATE® (Mildronate®)