Expiration date: 09/2021 

Active substance: Meldonium. 

The drug forms

Solution for injection: clear, colorless liquid.

Capsules: 250 mg - hard gelatine capsules size №1 white. 500 mg - hard gelatine capsules size №2 white.

The contents of capsules - a hygroscopic white crystalline powder with a weak smell.

Characteristic

Structural analog of gamma-butyrobetaine - material present in every cell of the human body.

Pharmachologic effect: Cardioprotective, anti-hypoxic, angioproteguoe, antianginal.

In high load conditions Mildronate® restores the balance between delivery and cellular oxygen demand, eliminating the accumulation of toxic products of metabolism in the cells, protecting them from damage; It 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 Mildronate® 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 Mildronate® 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 improves blood circulation in the ischemic focus, promotes redistribution of blood to the ischemic area. It is effective in the case of vascular and dystrophic pathology of the ocular fundus. The drug eliminates functional disturbances of the central nervous system in patients with chronic alcoholism during abstinence syndrome.

Pharmacokinetics

If ingestion is well absorbed. Bioavailability is about 78%. Cmax is achieved in 1-2 hours. Biotransformiroetsa in the body into two major metabolites which the kidneys. T1 / 2 - 6.3 hours, depending on the dose.

Testimony

Adults:

All formulations

  • complex therapy of IHD (angina, myocardial infarction);
  • chronic heart failure and cardiomyopathy dyshormonal and complex therapy of acute and chronic disorders of the brain blood supply (cerebral strokes and cerebrovascular insufficiency);
  • abstinence syndrome in chronic alcoholism (in combination with specific alcoholism therapy);
  • reduced working capacity, physical stress, including in athletes.

Injection

  • hemophthalmus and retinal hemorrhages of different etiologies;
  • thrombosis of the central retinal vein and its branches;
  • Retinopathy of different etiology (diabetic, hypertensive).

Contraindications

All formulations:

  • hypersensitivity;
  • increased intracranial pressure (in violation of the venous outflow, intracranial tumors).

Pregnancy and breast-feeding

The safety of the drug has not been proved during pregnancy. It is not clear whether the drug is excreted in breast milk. At the time of treatment should stop breastfeeding.

Side effects

Rarely - allergic reactions (redness, rash, itching, swelling), as well as dyspepsia, tachycardia, changes in blood pressure, agitation.

Interaction

It increases the vasodilatig funds, some antihypertensive drugs, cardiac glycosides. It can be combined with antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators. In view of the possible development of mild tachycardia and hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, antihypertensive agents and peripheral vasodilators.

Dosing and Administration

Capsules - inside injection - in / in, in the morning.

Cardiovascular disease, adults in the complex therapy: administration (capsule) - 0.5-1 g per day or / - 5.10 ml solution for injection in 1 or 2 divided doses. The course of treatment - 4-6 weeks.

Cardialgia amid dyshormonal myocardial dystrophy - orally (capsule), 0.25 g of 2 times a day. The course of treatment - 12 days.

Cerebrovascular accidents: acute phase - in / in 5 ml of solution for injection 1 times a day for 10 days, then orally (capsule) of 0.5-1 g per day. The course of treatment - 4-6 weeks. Chronic disorders - orally (capsule) of 0.5-1 g per day. The course of treatment - 4-6 weeks. Repeated courses (usually 2-3 times a year) are possible after consulting a doctor.

Vascular pathology and degenerative diseases of the retina: parabulbarno, 0.5 ml solution for injection for 10 days.

The mental and physical overload, including athletes, the optimum dosage - 1 g / day (0.25 g 4 times a day, or 0.5 g of 2 times a day). The course of treatment - 10-14 days. If necessary, repeat the treatment after 2-3 weeks. Athletes - by mouth (capsules), 0.5-1 g, 2 times daily before training. The duration of the preparatory period - 14-21 days, during the period of competition - 10-14 days.

Alcoholism: orally (capsule), 0.5 g 4 times a day; w / w, 5 ml of solution for injections 2 times a day. The course of treatment - 7-10 days.

Overdose: Cases of overdose are unknown.

Precautionary measures

Patients with chronic diseases of the liver and the kidneys in long-term use should be careful. Myocardial infarction is not a drug of first row.

There is insufficient data on the use of Mildronate® children.

Special instructions

No information about adverse effects on the reaction rate Mildronate®.

Manufacturer: PJSC «Grindex» (Grindeks), Latvia.

Storage conditions: The temperature is not above 25 ° C.

Keep out of the reach of children.

Shelf-life: 4 years.

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


FAQ

Mildronate
(Meldonium)