Composition, form of production and packaging
The solution for IV, IM and parabulbar injection is transparent, colorless.
meldonia dihydrate 500 mg,
which corresponds to the content of meldonia 401.05 mg
Auxiliary substances: water d / u - up to 5 ml.
5 ml - ampoules of colorless glass (5) - packings of cellular plastic (1) - packs cardboard.
5 ml - ampoules of colorless glass (5) - packings of cellular plastic (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
Meldonium is a structural analogue of gamma-butyrobetaine, a substance that is present in every cell of the human body.
Meldonium suppresses gamma-butyrobetaine hydroxy genase, reduces the synthesis of carnitine and transport of long chain fatty acids through cell membranes, prevents the accumulation of activated forms of unoxidized fatty acids - acylcarnicin and acylcoenzyme A - in the cells. Under conditions of ischemia, it restores the equilibrium of oxygen delivery and consumption in cells, transport of adenosine triphosphate (ATP). Simultaneously, it activates glycolysis, which proceeds without additional consumption of oxygen. As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is synthesized intensively. The mechanism of action determines the variety of its pharmacological effects: increasing the capacity for work, reducing the symptoms of mental and physical overstrain, the activation of tissue and humoral immunity, cardioprotective action.
In case of acute ischemic damage, the myocardium slows down the formation of the necrosis zone, shortens the rehabilitation period. With heart failure improves myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic impairment of cerebral circulation improves blood circulation in the source of ischemia.
Effective in the case of vascular pathology of the fundus.
The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism during the period of withdrawal.
C max in blood plasma is achieved immediately after administration. Metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. T 1/2 is 3-6 hours.
- in the complex therapy of IHD (angina pectoris, myocardial infarction); chronic heart failure, dyshormonal cardiomyopathy;
- as part of complex therapy of acute cerebrovascular accident (ischemic stroke, cerebrovascular insufficiency);
- reduced working capacity; physical overexertion (including athletes);
- Abstinence syndrome with chronic alcoholism (in combination with specific therapy);
- hemophthalmia and hemorrhages in the retina of the eye of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertonic).
In connection with the possibility of developing an exciting effect, the drug is recommended for use in the first half of the day.
For cardiovascular diseases, as part of a complex therapy, I / O 0.5-1 g (5-10 ml solution for IV and parabulbar injection 100 mg / ml), applying the entire dose at once or dividing it into 2 injections. The course of treatment is 10-14 days. Repeated courses (usually 2-3 times a year) - on the recommendation of a doctor.
In the acute phase of cerebral circulation disorders 500 mg (5 ml of the solution for IV and parabulbar injection of 100 mg / ml) are injected once / day for 10 days.
With reduced performance, physical overstrain (including athletes) with mental and physical exertion appoint IV dose of 500 mg (5 ml solution for iv and parabulbar injection 100 mg / ml) 1 time / day. The course of treatment is 10-14 days.
In case of abstinence syndrome with chronic alcoholism (in combination with specific therapy), iv 500 mg (5 ml of IV solution and parabulbar injection 100 mg / ml) is applied 2 times / day. The course of treatment is 10-14 days.
With ophthalmopathology (hemophthalmia and hemorrhage into the retina of the eye of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertonic) drug is administered parabulbarno to 50 mg (0.5 ml solution for iv and parabulbar injection 100 mg / ml) for 10 days, including as part of a combination therapy.
From the cardiovascular system: rarely - tachycardia, a decrease or increase in blood pressure.
From the side of the central nervous system: rarely - psychomotor agitation.
From the digestive system: rarely - dyspeptic disorders.
Allergic reactions: rarely - skin itching, rash, hyperemia of the skin, angioedema; very rarely - eosinophilia.
Other : very rarely - general weakness.
- hypersensitivity to the components of the drug;
- Increase in intracranial pressure (with violation of venous outflow and intracranial tumors);
- age under 18 years (efficiency and safety not established).
With caution: liver and / or kidney disease.
PREGNANCY AND LACTATION
The safety of the drug during pregnancy is not proven. To avoid possible adverse effects on the fetus, do not prescribe the drug during pregnancy.
It is not known whether the drug is excreted in breast milk. If you need to use Idrinol during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver disease.
APPLICATION FOR CHILDREN
Contraindication: age under 18 years (efficacy and safety not established).
Idrinol is not a first-line drug in acute coronary syndrome.
Impact on the ability to drive vehicles and manage mechanisms
Data on the adverse effects of the drug Idrinol on the rate of psychomotor reactions are not available.
Symptoms: decreased blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.
You can combine with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmics, diuretics, bronchodilators .
Strengthens the action of cardiac glycosides.
In view of the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-adrenoblockers, hypotensive drugs and peripheral vasodilators.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children at a temperature of no higher than 25 В° C; Do not freeze. Shelf life - 3 years. Do not use after the expiration date printed on the package.