INSTRUCTIONS FOR MEDICAL USE
METOLAN
Trade name of the drug: Metolan
Active substance (INN): Meldonium
Dosage form: Solution for injection.
Contents:
5 ml of the solution (1 ampoule) contains:
The active substance: Meldonium – 500 mg.
Excipients: Water for injection.
Description: Colorless, transparent liquid.
Pharmacotherapeutic group: Metabolic agents.
ATX code: C01EB22
Pharmacological properties
Meldonium is a structural analogue of gamma-butyrobetaine, a substance that is found in every cell of the human body.
Under increased stress, the drug restores the balance between supply and demand of cells for oxygen, eliminates the accumulation of toxic products of metabolism in the cells, protecting them from damage; it also has a tonic effect. As a result of its use, the body acquires the ability to withstand the load and quickly restore energy reserves. Due to these properties, the drug is used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to increase physical and mental performance. In acute ischemic myocardial damage, the drug slows down the formation of the necrotic zone and shortens the rehabilitation period. In heart failure, it increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic cerebral circulatory disorders improves blood circulation in the focus of ischemia, contributes to the redistribution of blood in favor of the ischemic area. It is effective in case of vascular and dystrophic ocular pathology. The drug eliminates the functional disorders of the nervous system in patients with chronic alcoholism during withdrawal syndrome.
Pharmacokinetics
Bioavailability of the drug after intravenous (IV) injection is 100%. Maximal concentration (Cmax) in blood plasma is reached immediately after administration. The drug is metabolized in the body to form two main metabolites, which are excreted by the kidneys. The elimination half-life (T1/2) is 3-6 hours.
Indications for use
As part of the complex therapy of coronary heart disease (angina pectoris, myocardial infarction), chronic heart failure and dyshormonal cardiomyopathy, and as part of the complex therapy of acute and chronic blood circulation disorders of the brain (stroke and cerebrovascular insufficiency).
Hemophthalmus and retinal hemorrhages of various etiologies, central retinal vein thrombosis and its branches, retinopathies of various etiologies (diabetic, hypertensive).
Reduced work capacity, physical overexertion, including in athletes. Withdrawal syndrome in chronic alcoholism (in combination with specific therapy).
Dosage and administration
Because of the possible development of the excitatory effect it is recommended to use in the morning.
Cardiovascular diseases
As part of the complex therapy of 0.5-1 g per day by IV (5-10 ml of a solution for injection 500 mg/5 ml), applying the entire dose at once or dividing it into 2 times. The course of treatment is 4-6 weeks.
Impaired cerebral circulation
Acute phase – 0.5 g 1 time a day v/v for 10 days, then switch to oral dosage form. The total course of treatment is 4-6 weeks.
Chronic disorders
- Oral dosage form is used. Repeated courses (usually 2-3 times a year) are possible after consultation with the doctor.
Vascular pathology and dystrophic retinal diseases
- Parabulbar 0.5 ml of 500 mg/5 ml solution for 10 days.
Mental and physical overload, including in athletes:
- Adults 0.5 g v/v (5-10 ml of 500 mg/5 ml solution for injection) once daily. The course of treatment is 10-14 days. If necessary, treatment should be repeated in 2-3 weeks.
Chronic alcoholism.
IV – 0.5 g 2 times a day. The course of treatment – 7-10 days.
Side effects
The cardiovascular system: rare – tachycardia, changes in blood pressure.
The central nervous system (CNS): rare – psychomotor agitation.
The digestive system: rare – dyspeptic symptoms.
Allergic reactions: rare – skin itching, redness, rash, swelling.
Contraindications
- Increased intracranial pressure (including with impaired venous outflow, intracranial tumors);
- Organic CNS lesions;
- pregnancy, lactation;
- hypersensitivity to the drug;
- under 18 years of age.
Drug interactions
Increases the effect of coronadilators, some hypotensive drugs, cardiac glycosides. It can be combined with antianginal drugs, anticoagulants, antiaggregants, antiarrhythmic drugs, diuretics and bronchodilators. Caution must be exercised when combining with nitroglycerin, nifedipine, alpha-adrenoblockers, hypotensive agents and peripheral vasodilators because of possible development of moderate tachycardia and arterial hypotension.
Special indications
Caution should be exercised in patients with chronic liver and renal diseases during long-term use of the drug. There are no sufficient data on the use of meldonium in children.
Many years of experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments show that meldonium is not a first-line drug for acute coronary syndrome.
Use during pregnancy and lactation.
The safety of using the drug during pregnancy has not been proven.
To avoid possible adverse effects on the fetus, it is not prescribed during pregnancy.
It is not known whether the drug is excreted with the milk of the mother. If the drug treatment for the mother is necessary, breastfeeding of the child is stopped.
Effect on the ability to drive vehicles and operate other mechanisms.
There are no data on adverse effects of the drug on the speed of psychomotor reactions.
Form of production
Solution for injection 500 mg/5 ml in 5 ml ampoules N5(1×5), N10(2×5)
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children! Do not freeze!
Shelf life
4 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released by doctor’s prescription.