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

Active ingredient

Composition

1 ml of the solution contains:

How to take, the dosage

Because of the possible development of an excitatory effect, it is recommended to use in the morning.

MILDRONAT® is administered intramuscularly (i.m.), intravenously (i.v.) and parabulbarously. Type of administration, dosage and duration of treatment shall be determined individually depending on indications and severity of the condition, etc.

1. Cardiovascular diseases

As part of the complex therapy:

– coronary heart disease (myocardial infarction) by IV infusion 0.5-1.0 g per day (5 10 ml of MILDRONAT®);

– coronary heart disease (stable angina pectoris); chronic heart failure and cardiomyopathy against the background of dyshormonal disorders by injection 0.5-1.0 g per day (5-10 ml of the preparation MILDRONAT®) or intravenously 0.5 g 1-2 times per day, treatment course 10-14 days with subsequent change to oral administration. Total course of treatment is 4 6 weeks.

2. cerebral circulation disorders

In combination therapy in acute phase using 0,5 g (5 ml of the preparation MILDRONAT®) once a day by IV for 10 days changing to oral administration 0,5 1 g. Total course of treatment is 4-6 weeks.

In chronic insufficiency of cerebral circulation (discirculatory encephalopathy) 0,5 g (5 ml of the preparation MILDRONAT®) once daily by injection or intravenously for 10 days then by 0,5 g internally. Total course of treatment is 4 6 weeks.

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

3. ophthalmopathology (hemophthalmia and hemorrhages in the retina of different etiology, central retinal vein thrombosis and its branches, retinopathies of different etiology (diabetic, hypertensive).

In 0,05 g (0,5 ml of the drug MILDRONAT®) parabulbar for 10 days. It is also used as part of combination therapy.

4. Mental and physical overload

Please 0.5 g (5 ml of MILDRONAT®) in m/v or intravenously once a day. The course of treatment is 10 14 days. If necessary the treatment is repeated in 2-3 weeks.

5 Chronic alcoholism

0.5 g (5 ml of the preparation MILDRONAT®) per m or v/v 2 times a day. The course of treatment is 7 10 days.

Interaction

When used together Mildronate increases the effect of antianginal agents, some hypotensive drugs, cardiac glycosides.

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

When nitroglycerin, nifedipine, alpha-adrenoblockers, hypotensive agents and peripheral vasodilators are combined with Mildronate, moderate tachycardia and arterial hypotension may develop (caution should be exercised when using this combination).

Special Instructions

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

Meldonium has been on the World Anti-Doping Agency’s list of banned substances since January 1, 2016.

Impact on driving and operating ability

There are no data on adverse effects of MILDRONAT® on psychomotor reaction speed.

Synopsis

Contraindications

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

Side effects

Depending on the frequency of occurrence, the following WHO groups of adverse reactions are distinguished: Very common (>1/10), common (>1/100, < 1/10), infrequent (>1/1000, < 1/100), rare (>1/10000, < 1/1000), very rare (< 1/10000), including individual reports, frequency unknown – cannot be determined from available data.

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

Overdose

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

Treatment: symptomatic.

MILDRONAT® is mildly toxic and does not cause adverse reactions hazardous to patients.

Pregnancy use

The safety of using Mildronate in 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 with breast milk.

Breastfeeding should be stopped if Mildronate needs to be used during lactation.

Similarities