Product Overview
Composition
The contents of the capsules are white or almost white crystalline powder with a faint odor;
The powder is hygroscopic, clumping is allowed.
1 caps. contains:
Meldonium dihydrate 250 mg
Excipients:
Potato starch - 13.3 mg,
Colloidal silicon dioxide (aerosil) - 5.7 mg,
Calcium stearate - 2.7 mg
Capsule shell composition:
Gelatin,
Titanium dioxide
pharmachologic effect
Pharmacodynamics
synthetic analogue of gamma-butyrobetaine, gamma butirobetaingidroksilazu inhibits, reduces the synthesis of carnitine and transportation of long chain fatty acids across cell membranes and prevents the accumulation of cells in the activated forms of unoxidized fatty acids - acylcarnitine derivatives and atsilkofermenta A.
As a result of reducing the concentration of carnitine intensively synthesized gamma-butyrobetaine which has vasodilating properties.
Under conditions of ischemia, meldonium restores the equilibrium of the processes of oxygen delivery and its consumption in cells, prevents the disruption of the transport of adenosine triphosphate (ATP): at the same time, it activates glycolysis, which proceeds without additional oxygen consumption.
The mechanism of action determines the variety of pharmacological effects of meldonium: increased efficiency, reduced symptoms of mental and physical stress, activation of immunity, cardioprotective effect.
In the case of acute ischemic damage to the myocardium, it slows down the formation of a 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.
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.
Characterized by a tonic effect on the central nervous system, elimination of functional disorders of the autonomic division of the nervous system with withdrawal syndrome in patients with chronic alcoholism.
Pharmacokinetics
After oral administration, it is rapidly absorbed from the gastrointestinal tract, bioavailability is 78%.
The maximum concentration in blood plasma is reached after 1-2 hours.
It is metabolized in the body with the formation of two main metabolites, which are excreted by the kidneys.
The half-life depends on the dose and is 3-6 hours.
Indications
For oral administration or intravenous administration: as part of the complex therapy of ischemic heart disease (angina pectoris, myocardial infarction), chronic heart failure, dyshormonal cardiomyopathy; as part of the complex therapy of acute
and chronic disorders of cerebral circulation (strokes and cerebrovascular insufficiency); decreased performance, physical overstrain (including in athletes), postoperative period for acceleration
rehabilitation; withdrawal syndrome in chronic alcoholism (in combination with specific therapy for alcoholism).
For parabulbar injection: acute circulatory disorders in the retina, hemophthalmos 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.
Application during pregnancy and lactation
During pregnancy and lactation (breastfeeding), the use of the drug is contraindicated.
Contraindications
Hypersensitivity to the main and / or auxiliary components of the drug; increased intracranial pressure (with impaired venous outflow and intracranial tumors); pregnancy; period of breastfeeding; age up to 18 years (efficacy and safety have not been established).
Carefully
Chronic liver and / or kidney disease (due to insufficient data).
Side effects
From the side of the cardiovascular system: tachycardia, decrease or increase in blood pressure.
From the gastrointestinal tract: dyspeptic symptoms.
From the side of the central nervous system: agitation.
Allergic reactions: skin redness and itching, rash, swelling.
Others: eosinophilia, general weakness.
Interaction
Can be combined with antianginal drugs, anticoagulants, antiplatelet agents. antiarrhythmic drugs and drugs, etc. diure geek and. bronchodilators.
Strengthens the effect of coronary dilating, some antihypertensive drugs, cardiac glycosides.
When used together with nitroglycerin, nifedipine, alpha-blockers. other antihypertensive drugs and drugs and peripheral vasodilators should be used with caution in view of the possible development of moderate tachycardia and arterial hypotension.
How to take, course of administration and dosage
Inside. The capsules should be swallowed whole, washed down with water.
In view of the possible development of an exciting effect, the drug is recommended to be used in the first half of the day.
Reduced performance, mental and physical overload - 500 mg (2 capsules) 2 times a day.
The course of treatment is 10-14 days. If necessary, the treatment is repeated after 2 - 3 weeks.
Athletes - 500 mg - 1.0 g (2 - 4 capsules) 2 times a day before training. The duration of the course in the preparatory period of training is 14 - 21 days, during the competition period - 10 - 14 days.
Ischemic heart disease (exertional angina), chronic heart failure - 500 mg - 1.0 g (2 - 4 capsules) per day, using the entire dose at once or dividing it into 2 doses. The course of treatment is 4-6 weeks.
Cardialgia with dyshormonal myocardial dystrophy - 250 mg 2 times a day. The course of treatment is 12 days.
Cerebral circulation disorder.
In case of ischemic stroke - after the end of the 10-day course of therapy with the injectable form of Cardionat®, the patient is transferred to taking the drug orally in capsules of 500 mg - 1.0 g (2 - 4 capsules) per day, taking the entire dose at once or dividing it into 2 doses. The general course of treatment is 4-6 weeks.
In chronic cerebrovascular insufficiency - 500 mg (2 capsules) per day. The course of treatment is 2 - 3 weeks. The need for repeated courses of treatment (2-3 times a year) is determined by the doctor.
Withdrawal symptoms in chronic alcoholism - 500 mg (2 capsules) 4 times a day. The course of treatment is 7-10 days.
Overdose
Symptoms: a decrease in blood pressure, accompanied by headache, tachycardia, dizziness, general weakness.
Treatment is symptomatic.
Special instructions
When treating patients with chronic liver and kidney diseases, caution should be exercised, especially with prolonged use of the drug.
Insufficient data on use in children.
Influence on the ability to drive vehicles and mechanisms
There is no data on the adverse effect of Cardionat® on the ability to drive vehicles and mechanisms.
Release form
10 capsules in a blister strip made of polyvinyl chloride film and aluminum foil.
100 capsules in polymer jars for medicines, sealed with lids.
A polymer can or 2, 4 or 10 blisters together with instructions for use in a cardboard box.
Storage conditions
In a dry place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
