Cardionat solution for injection 100mg / ml, No. 10

• In complex therapy: ischemic heart disease (angina pectoris, myocardial infarction), chronic heart failure, cardialgia against the background of dyshormonal myocardial dystrophy.

• In complex therapy: disorders of cerebral circulation (ischemic stroke, cerebrovascular insufficiency).

• In complex therapy: acute circulatory disorders in the retina, hemophthalmus and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (including diabetic and hypertensive) - only for parabulbar administration.

• Reduced performance, physical stress (including in athletes).

• Withdrawal alcohol syndrome (as part of a complex specific therapy).

In view of the possible stimulating effect, the drug is recommended to be used in the first half of the day.

Angina pectoris and myocardial infarction (as part of combination therapy) : intravenously (i.v.) 0.5-1 g (5-10 ml solution for injection 100 mg / 1 ml) 1 time per day, then switch to taking the drug orally.

Chronic heart failure (as part of combination therapy) : intravenous 0.5-1 g (5-10 ml of solution for injection) 1 time per day: course of treatment - 10-14 days, then switch to taking the drug inside.

Cardialgia against the background of dyshormonal dystrophy of the myocardium : intravenously , 0.5-1 g (5-10 ml solution for injection) 1 time per day or intramuscularly, 0.5 g 1-2 times a day; the course of treatment is 10-14 days, then they switch to taking the drug inside.

Violation of cerebral circulation (as part of combination therapy) : acute phase - intravenous, 500 mg (5 ml solution for injection) 1 time per day for 10 days, then it is possible to switch to oral administration; chronic disorders of cerebral circulation ', intramuscularly, 500 mg (5 ml solution for injection) 1 time per day; the course of treatment is 10-14 days, then it is possible to switch to taking the drug inside.

Vascular pathology of the fundus and retinal dystrophy (in complex therapy) : 0.5 ml parabulbar injection solution for 10 days.

Physical and mental overload : in / in 0.5 g (5 ml solution for injection) once a day; the course of treatment is 10-14 days. If necessary, repeat the course in 2-3 weeks.

Withdrawal alcohol syndrome: intravenous , 500 mg (5 ml solution for injection) 2 times a day; the course of treatment is 7-10 days.

For one ampoule:
Active substance Meldonium dihydrate (trimethylhydrazinium propionate dihydrate) in terms of dihydrate without adsorbed moisture - 500 mg;
Excipients Water for injection - 5 ml.

Hypersensitivity to the drug; increased intracranial pressure (with impaired venous outflow and intracranial tumors); pregnancy, lactation, age up to 18 years.

Carefully

Liver and / or kidney disease.

Composition

For one ampoule:
Active substance Meldonium dihydrate (trimethylhydrazinium propionate dihydrate) in terms of dihydrate without adsorbed moisture - 500 mg;
Excipients Water for injection - 5 ml.

Description

Transparent colorless liquid.

Pharmacotherapeutic group

Metabolic agent.

Pharmacological properties

Pharmacodynamics
Structural analogue of gamma-butyrobetaine. Meldonium inhibits gamma-butyrobeta and hydroxylase. which leads to a decrease in the synthesis of carnitine. restricting the transport of long-chain fatty acids into cells and prevents the accumulation of activated forms of unoxidized fatty acids - derivatives of acylcarnitine and acyl-coenzyme A. Under ischemic conditions, restores the balance of oxygen delivery and consumption, activates glycolysis; prevents disruption of transport and a decrease in the level of adenosine triphosphate (AGF). As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized.

In the case of acute ischemic myocardial damage, it slows down the formation of a necrotic zone, shortens the rehabilitation period. In chronic heart failure (CHF), it increases exercise tolerance. With angina pectoris, exertion reduces the frequency of attacks. In acute and chronic ischemic disorders of cerebral circulation, it improves blood circulation in the ischemic focus, promotes blood redistribution in favor of the ischemic area. Effective in the case of vascular and dystrophic pathology of the fundus. It has a tonic effect on the central nervous system, helps to eliminate functional disorders of the somatic and vegetative parts of the nervous system in patients with chronic alcoholism during the period of abstinence. Reduces the severity of symptoms of mental and physical stress.

Pharmacokinetics
After intravenous administration, the maximum concentration of the drug in the blood plasma is achieved immediately after its administration. There are no data on the bioavailability of the drug after intramuscular administration. It is metabolized in the body with the formation of two main metabolites, which are excreted by the kidneys. The half-life is 3-6 hours.

Indications for use

• In complex therapy: ischemic heart disease (angina pectoris, myocardial infarction), chronic heart failure, cardialgia against the background of dyshormonal myocardial dystrophy.

• In complex therapy: disorders of cerebral circulation (ischemic stroke, cerebrovascular insufficiency).

• In complex therapy: acute circulatory disorders in the retina, hemophthalmus and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (including diabetic and hypertensive) - only for parabulbar administration.

• Reduced performance, physical stress (including in athletes).

• Withdrawal alcohol syndrome (as part of a complex specific therapy).

Contraindications

Hypersensitivity to the drug; increased intracranial pressure (with impaired venous outflow and intracranial tumors); pregnancy, lactation, age up to 18 years.

Carefully

Liver and / or kidney disease.

Application during pregnancy and during breastfeeding

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Method of administration and dosage

In view of the possible stimulating effect, the drug is recommended to be used in the first half of the day.

Angina pectoris and myocardial infarction (as part of combination therapy) : intravenously (i.v.) 0.5-1 g (5-10 ml solution for injection 100 mg / 1 ml) 1 time per day, then switch to taking the drug orally.

Chronic heart failure (as part of combination therapy) : intravenous 0.5-1 g (5-10 ml of solution for injection) 1 time per day: course of treatment - 10-14 days, then switch to taking the drug inside.

Cardialgia against the background of dyshormonal dystrophy of the myocardium : intravenously , 0.5-1 g (5-10 ml solution for injection) 1 time per day or intramuscularly, 0.5 g 1-2 times a day; the course of treatment is 10-14 days, then they switch to taking the drug inside.

Violation of cerebral circulation (as part of combination therapy) : acute phase - intravenous, 500 mg (5 ml solution for injection) 1 time per day for 10 days, then it is possible to switch to oral administration; chronic disorders of cerebral circulation ', intramuscularly, 500 mg (5 ml solution for injection) 1 time per day; the course of treatment is 10-14 days, then it is possible to switch to taking the drug inside.

Vascular pathology of the fundus and retinal dystrophy (in complex therapy) : 0.5 ml parabulbar injection solution for 10 days.

Physical and mental overload : in / in 0.5 g (5 ml solution for injection) once a day; the course of treatment is 10-14 days. If necessary, repeat the course in 2-3 weeks.

Withdrawal alcohol syndrome: intravenous , 500 mg (5 ml solution for injection) 2 times a day; the course of treatment is 7-10 days.

Side effect

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

Overdose

Symptoms : decreased blood pressure, headache, tachycardia, dizziness, general weakness.
Treatment is symptomatic.

Interaction with other medicinal products

Strengthens the effect of coronary dilating and antihypertensive drugs, 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, antihypertensive drugs and peripheral vasodilators.

Can be combined with antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmic drugs, diuretics, bronchodilators.

special instructions

The drug should be used with caution in liver and / or kidney diseases, especially for a long time.

Long-term experience in the treatment of acute myocardial infarction and unstable angina pectoris in cardiology departments shows that meldonium is not a first-line drug in acute coronary syndrome and its use is not urgently needed.

Influence on the ability to drive vehicles and service other mechanisms
There is no data on the adverse effects of meldonium on the speed of psychomotor reactions.

Release form

Solution for injection 100 mg / ml. 5 ml in neutral glass ampoules.
5 ampoules are packed in a blister strip made of polyvinyl chloride film.
1, 2 blister packs, together with instructions for use and a knife for opening ampoules (in the case of using ampoules with a dot or break ring, the knife is not inserted) in a cardboard pack.

Storage conditions

At a temperature not higher than 25 ? C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiration date printed on the package.

Vacation conditions

On prescription.