Description
Release form
Injection 100 mg / ml.
Packaging
5 ml in ampoules of low density polyethylene or polypropylene.
For 5 or 10 ampoules, along with instructions for use in a pack of cardboard.
Pharmacological action
Pharmacotherapeutic group
Metabolic agent.
ATX code: ะก01EB
Pharmacological properties of
Pharmacodynamics
Meldonium is a structural analogue of gamma-butyrobetaine – a substance that is found in every cell of the human body. Under conditions of increased load, meldonium restores the balance between delivery and oxygen demand of cells, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage also has a tonic effect. As a result of its use, the body acquires the ability 2 to withstand the load and quickly restore energy reserves.
Due to these properties, meldonium is used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to increase physical and mental performance. As a result of a decrease in carnitine concentration, gamma-butyrobetaine with vasodilating properties is intensely synthesized. In case of acute ischemic damage to the myocardium, meldonium slows down the formation of the necrotic zone and shortens the rehabilitation period.
With heart failure, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral circulation improves blood circulation in the focus of ischemia, contributes to the redistribution of blood in favor of the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.
Pharmacokinetics
The bioavailability of the drug after intravenous administration is 100%. The maximum concentration in blood plasma is achieved immediately after its introduction. It is metabolized in the body with the formation of two main metabolites that are excreted by the kidneys. The half-life (T1 / 2) is 3-6 hours.
Indications
In the treatment of coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure and cardiomyopathy due to dishormonal disorders, as well as in the treatment of acute and chronic cerebrovascular disorders (stroke and cerebrovascular insufficiency).
Hemophthalmus and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic and hypertensive).
Decreased mental and physical overload (including athletes).
The drug can give a positive result during the doping control (see section “Special instructions”). Abstinence syndrome in chronic alcoholism (in combination with specific therapy for alcoholism).
Contraindications
Hypersensitivity to the drug, increased intracranial pressure (with impaired venous outflow, intracranial tumors), age up to 18 years (efficacy and safety have not been established), pregnancy, period of breastfeeding.
Precautions
For liver and / or kidney disease.
Use during pregnancy and lactation
The safety of use in pregnant women has not been studied, in order to avoid possible adverse effects on the fetus, its use is contraindicated.
Isolation of the drug with milk and its effect on the health status of the newborn has not been studied, therefore, if necessary, stop breast-feeding.
Special instructions
Years of experience in the treatment of acute myocardial infarction and unstable angina in the cardiology departments show that meldonium is not a first-line drug in acute coronary syndrome and its use is not urgently needed. Since January 1, 2016, meldonium has been included in the list of banned substances of the World Anti-Doping Agency.
Influence on the ability to drive vehicles and mechanisms
There is no data on the adverse effects of the drug on the speed of the psychomotor reaction.
Composition of
1 ml of the preparation contains:
Active ingredient:
Meldonium dihydrate 100 mg
Excipient:
Water for injection up to 1 ml
Description
A clear, colorless liquid.
Dosage and administration
Due to its possible stimulating effect, the drug is recommended to be used in the morning.
The drug is administered intramuscularly, intravenously and parabulbarno.
The route of administration, doses and duration of treatment are determined by
individually depending on the indications, severity of the condition, etc.
Cardiovascular diseases
As part of the complex therapy:
– coronary heart disease (myocardial infarction) intravenously by stream 0.5-1 , 0 g per day (5-10 ml of the drug)
– coronary heart disease (stable angina pectoris), chronic heart failure and cardiomyopathy on the background of dishormonal disorders intravenously in a jet of 0.5-1.0 g per day (5-10 ml of the drug) or intramuscularly in 0.5 g 1-2 times a day, the course of treatment is 10-14 days, with the subsequent transition to oral administration. The general course of treatment is 4-6 weeks.
Disturbances of cerebral circulation
As part of complex therapy in the acute phase, 0.5 g (5 ml of the drug) once a day intravenously for 10 days, switching to oral administration of 0.5-1.0 g. General course of treatment 4 -6 weeks.
In case of chronic cerebrovascular insufficiency (discirculatory encephalopathy), 0.5 g (5 ml of the drug) intramuscularly or intravenously 1 time per day for 10 days, then 0.5 g orally. The general course of treatment is 4-6 weeks.
Repeated courses (usually 2-3 times a year) are possible after consultation with a doctor.
Ophthalmopathology (hemophthalmus and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic, hypertensive)).
At 0.05 g (0.5 ml of the drug) parabulbar for 10 days. It is also used as part of combination therapy.
Mental and physical overload
0.5 g (5 ml of the drug) intramuscularly or intravenously once a day. The course of treatment is 10-14 days. If necessary, repeat the course after 2-3 weeks.
Chronic alcoholism
0.5 g (5 ml of the drug) intramuscularly or intravenously 2 times a day. The course of treatment is 7-10 days.
Procedure for working with a polymer ampoule:
1. Take the ampoule and shake it, holding it by the neck.
2. Squeeze the ampoule with your hand, while the drug should not be released, and
rotate and separate the valve with rotational movements.
3. Through the hole formed, immediately connect the syringe to the ampoule.
4. Turn the ampoule over and slowly draw its contents into the syringe.
5. Put the needle on the syringe.
Side effects
Depending on the frequency of occurrence, the following groups of unwanted adverse reactions are distinguished according to WHO: very often (? 1/10) often (? 1/100 to <1/10) infrequently (? 1/1000 to <1/100 ) rarely (? 1/10000 to < 1/1000) very rarely (<1/10000) including individual messages, the frequency is unknown - cannot be determined from the available data). Rarely, allergic reactions (redness, rash, itching, swelling), as well as dyspeptic symptoms, tachycardia, decreased or increased blood pressure, agitation. Very rarely – eosinophilia, general weakness. Drug Interactions Can be combined with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmic drugs, diuretics, bronchodilators. Enhances the action of cardiac glycosides. Due to the possible development of moderate tachycardia and arterial hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, other antihypertensive drugs and peripheral vasodilators, since meldonium enhances their effect. overdose Symptoms: decreased blood pressure, accompanied by headache, tachycardia, dizziness and general weakness. Treatment: symptomatic. The drug is low toxic and does not cause adverse reactions dangerous to the health of patients. Storage Conditions Do not store above 25 C. Keep out of the reach and sight of children. Shelf life 4 years. Do not use after expiration date! Deystvuyushtee substance Melydoniy drugstore terms drugstore Indications Prevention of acute myocardial infarction, Chronic circulatory failure, Angina pectoris, Prevention of stroke Possible product names Meldonium – SOLOpharm Politvist injection solution 100 mg / ml 5 ml ampoules plastic 10 pcs.
