Mildronate, 100 mg/ml 5 ml 10 pcs

Meldonium (MILDRONAT®) is a structural analogue of gamma-butyrobetaine, a substance found in every cell of the human body.
Under conditions of increased stress, MILDRONAT® restores the balance between cellular oxygen supply and demand, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; it also has a tonic effect. As a result of its use, the body acquires the ability to withstand stress and quickly restore energy reserves. Thanks to these properties, MILDRONAT® is used to treat various disorders of the cardiovascular system and cerebral blood supply, as well as to improve physical and mental performance. As a result of decrease of carnitine concentration, gamma-butyrobetaine, which possesses vasodilatory properties, is intensively synthesized. In acute ischemic myocardial damage, MILDRONAT® slows down the formation of the necrotic zone and shortens the rehabilitation period. In case of heart failure, it increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. Mildronat® improves blood circulation in ischemic areas, promotes blood redistribution in favor of ischemic areas. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism in withdrawal syndrome.

PHARMACOLOGICAL ACTION
Cardioprotective agent normalizing myocardial metabolism and vasodilator properties.

PHARMACOKINETICS
Bioavailability of the drug after intravenous administration is 100%. Maximal concentration in blood plasma is reached immediately after administration. The drug is metabolized in the body to form two main metabolites, which are excreted by the kidneys. The elimination half-life (T1/2) is 3 – 6 hours.

Indications

In complex therapy of coronary heart disease (angina pectoris, myocardial infarction); chronic heart failure and cardiomyopathy against the background of dishormonal disorders, as well as in complex therapy of acute and chronic disorders of the blood supply to the brain (stroke and cerebrovascular insufficiency).
Hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic, hypertensive).
Reduced performance; mental and physical overload (including among athletes). The drug may give a positive result during doping control (see section “Special instructions”).
Withdrawal syndrome in chronic alcoholism (in combination with specific therapy for alcoholism).

Pharmacological effect

Meldonium (MILDRONATE®) is a structural analogue of gamma-butyrobetaine, a substance that is found in every cell of the human body.
Under conditions of increased stress, MILDRONATE® restores the balance between the supply and need of cells for oxygen, eliminates the accumulation of toxic metabolic products in 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. Thanks to these properties, MILDRONATE® is used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to improve physical and mental performance. As a result of a decrease in carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized. In case of acute ischemic damage to the myocardium, MILDRONATE® slows down the formation of the necrotic zone and shortens the rehabilitation period. In 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 area and promotes the redistribution of blood in favor of the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.

PHARMACOLOGICAL ACTION
A cardioprotective agent that normalizes myocardial metabolism and has vasodilating properties.

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

Special instructions

Many years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments show that MILDRONATE® is not a first-line drug for acute coronary syndrome and its use is not urgently necessary.

Since January 1, 2016, meldonium has been included in the list of prohibited substances of the World Anti-Doping Agency.

Impact on the ability to drive vehicles and machinery

There is no data on the adverse effects of the drug MILDRONATE® on the speed of psychomotor reaction.

Active ingredient

Meldonium

Composition

1 ml of solution contains:

active ingredient – meldonium dihydrate 100 mg;
excipient – water for injection.

Pregnancy

The safety of Mildronate during pregnancy has not been proven.

To avoid possible adverse effects on the fetus, the drug should not be prescribed during pregnancy.

It is not known whether the drug is excreted in breast milk.

If it is necessary to use Mildronate during lactation, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to the components of the drug, increased intracranial pressure (due to impaired venous outflow, intracranial tumors), age under 18 years (efficacy and safety have not been established), pregnancy, breastfeeding.

Side Effects

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, 1/1000, 1/10000, <1/1000), very rarely (<1/10000), including isolated reports, frequency unknown - cannot be determined from the available data.

Rarely – allergic reactions (redness, rashes, itching, swelling), as well as dyspeptic symptoms, tachycardia, decreased or increased blood pressure, agitation. Very rarely – eosinophilia, general weakness.

Interaction

When used together, Mildronate enhances the effect of antianginal drugs, some antihypertensive drugs, and cardiac glycosides.

Mildronate can be combined with antianginal agents, anticoagulants and antiplatelet agents, antiarrhythmic agents, diuretics, and bronchodilators.

When used together with Mildronate, nitroglycerin, nifedipine, alpha-blockers, antihypertensive drugs and peripheral vasodilators may develop moderate tachycardia and arterial hypotension (care should be taken when using this combination).

Overdose

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

Treatment: symptomatic.

MILDRONATE® is low-toxic and does not cause unwanted reactions that are dangerous to the health of patients.

Storage conditions

Store at a temperature not exceeding 25C.
Do not freeze!
Keep out of the reach of children!

Shelf life

5 years.
Do not use after the expiration date indicated on the package.

Manufacturer

Santonika JSC, Latvia