Instruction for Use: Mildronate injection

Tradename: Mildronate®

International Non-Proprietary Name (INN):Meldonium

chemical name
3- (2,2,2-trimethylhydrazinium) propionate dihydrate.

Dosage Form:
Meldonium solution for intramuscular administration, and intravenous administration parabulbarly.

Structure1 ml solution contains:
active ingredient - meldonium dihydrate 100 mg;
adjuvant - water for injection.

Description

Clear, colorless liquid.

Pharmacotherapeutic group:
metabolic means

ATC code: Ñ01ÅÂ

Pharmachologic effect

Pharmacodynamics
Meldonium - structural analog of gamma-butyrobetaine - a substance that is in every cell of the human body.In high load conditions Meldonium restores the balance between delivery and cellular oxygen demand, eliminating the accumulation of toxic products of metabolism in the cells, protecting them from damage; also has a tonic effect. As a result of its use of the body acquires the ability to withstand stress and to quickly restore energy reserves. Because of these properties Meldonium used to treat a variety of disorders of the cardiovascular system, the blood supply to the brain, as well as to improve physical and mental performance. As a result of reducing the concentration of carnitine is synthesized hard gamma-butyrobetaine, which has vasodilating properties. In the case of acute ischemic myocardial injury Meldonium slows the formation of necrotic areas, shorten the rehabilitation period. In heart failure, increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders Meldonium improves blood circulation in the ischemic focus, promotes redistribution of blood to the ischemic area.
The drug eliminates functional disturbances of the nervous system in patients with chronic alcoholism during abstinence syndrome.

Pharmacokinetics

The bioavailability of the drug following intravenous administration is 100%. The maximum plasma concentration is reached immediately after its introduction. It is metabolized in the body into two major metabolites which the kidneys. The half-life (T1 / 2) is 3-6 hours.

Indications
In the treatment of coronary heart disease (angina, myocardial infarction); chronic heart failure and cardiomyopathy dyshormonal, as well as in the treatment of acute and chronic disorders of blood supply to the brain (stroke and cerebrovascular insufficiency). Hemophthalmus and retinal hemorrhages of different etiologies, thrombosis of the central retinal vein and its branches, retinopathy of different etiology (diabetic, hypertensive).Reduced working capacity; mental and physical overload (including the athletes).
abstinence syndrome in chronic alcoholism (in combination with specific alcoholism therapy).

Contraindications
Hypersensitivity to Meldonium or any other component of the drug. Increased intracranial pressure (in violation of the venous outflow, intracranial tumors). Pregnancy and breast-feeding. Age 18 years (safety is not confirmed).
Precautions: in diseases of the liver and / or kidneys.

Application of pregnancy and during breastfeeding

Health and Safety in pregnant women has not been studied, therefore, in order to avoid possible adverse effects on the fetus, use of the drug is contraindicated in pregnant women.Withdrawal of milk and effects on the health of the newborn have not been studied, therefore, if necessary, the drug should stop breastfeeding.

Dosing and Administration
In view of the possible development of stimulating effect, it is recommended to use in the morning. Meldonium administered intramuscularly (i / m), intravenous (i / v) and parabulbarly.The method of administration, the dose and duration of treatment is determined individually depending on the indication, the severity of the condition and others.
1. Cardiovascular disease
In the combined therapy:
coronary heart disease (myocardial infarction) in / jet by 0.5-1.0 g per day (5-10 ml of the drug Meldonium ), using the entire dose at once or dividing it into 2 of the introduction;
coronary heart disease (stable angina); congestive heart failure and cardiomyopathy dyshormonal in / jet by 0.5-1.0 g per day (5-10 ml of the drug Meldonium ), using the entire dose at once or dividing it into 2 administration, or / m 0.5 g 1-2 times a day, a course of treatment 10-14 days, followed by transfer to a reception inside.The total course of treatment 4-6 weeks.
2. Violation of cerebral circulation
In the combined therapy in the acute phase of 0.5 g (5 ml of the drug Meldonium ) 1 time per day / in 10 days, going to the ingestion of 0.5-1 The total course of treatment - 4-6 weeks. In chronic cerebrovascular insufficiency (vascular encephalopathy) 0.5 g (5 ml Meldonium drug) in the / m or / 1 time a day for 10 days, followed by 0.5 g orally. The total course of treatment -4-6 weeks.
Repeated courses (usually 2-3 times a year) are possible after consultation with the doctor.
3. Ophthalmopathology (hemophthalmus and retinal hemorrhages of different etiologies, thrombosis of the central retinal vein and its branches, retinopathy of different etiology (diabetic, hypertensive)).
0.05 g (0.5 ml preparation Meldonium ) parabulbarly for 10 days. Including used in a combination therapy.
4. Mental and physical overload
0.5 g (5 ml of the drug Meldonium ) in / m or / 1 time per day. The course of treatment -10-14 days. If necessary, the treatment is repeated after 2-3 weeks.
5. Chronic alcoholism
0.5 g (5 ml Meldonium drug) / m or V / 2 times per day. The course of treatment -7-10 days.

Side effect

Rarely - allergic reactions (redness, rash, itching, swelling), as well as dyspepsia, tachycardia, decrease or increase in blood pressure, agitation. Very rarely - eosinophilia, general weakness.

Overdose

Symptoms: reduced blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.Treatment: symptomatic.
Meldonium low toxicity and does not cause side effects that are dangerous to the health of patients.

Interaction with other drugs
It can be combined with antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators. It enhances the effect of cardiac glycosides.
In view of the possible development of mild tachycardia and hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, other antihypertensive agents and peripheral vasodilators, as Meldonium reinforces their action.

Special instructions

Many years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments shows that Meldonium not the drug of I series with acute coronary syndrome and its use is not absolutely necessary.
Effects on ability to drive and use machines
No data on the adverse effects of the drug on Meldonium speed of psychomotor reactions.

Release Form

Meldonium Solution for intramuscular administration, and intravenous administration parabulbarly, 100 mg / ml.
5 mL clear glass vial with a fault line or point.5 vials in cellular packaging made of PVC film or polyethylene terephthalate film without coating (pan).
Two stripes package (pallet), together with instructions for use in a stack of cardboard.

Storage conditions
Store at temperatures not above 25 ° C.
Do not freeze!
Keep out of the reach of children.

Shelf life
4 years.

Do not use beyond the expiration date printed on the package.