Meldonium -SOLOPHARM Politvist solution for injection 100mg/ml 5ml ampoules plastic, 10pcs

Composition

>1 ml of the drug contains: Active ingredient: Meldonium dihydrate 100 mg Auxiliary Substance: Water for injection up to 1 mldescription: Transparent, colorless liquid.

Pharmacological action

Pharmacotherapeutic groupmetabolic agent. ATX code: C 01PHARMACOLOGICAL Propertiespharmacodynamicmeldonium is a structural analog of gamma-butyrobetaine – a substance found in every cell of the human body. Under conditions of increased stress, meldonium restores the balance between the delivery and demand of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; it also has a tonic effect. As a result of its application, 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 the carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized. In the case of acute ischemic myocardial injury, meldonium slows down the formation of the necrotic zone, shortens the rehabilitation period. With heart failure, it increases tolerance to physical activity, reduces the frequency of angina attacks. In acute and chronic ischemic disorders of the cerebral circulation, it improves blood circulation in the focus of ischemia, promotes blood redistribution in favor of the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal symptoms. Pharmacokinetics The bioavailability of the drug after intravenous use is 100%. The maximum concentration in blood plasma is reached immediately after its use. It is metabolized in the body to form two main metabolites, which are excreted by the kidneys. The elimination half-life (T 1/2) is 3-6 hours.

Indications

In the complex therapy of ischemic heart disease (angina pectoris, myocardial infarction); chronic heart failure and cardiomyopathy against the background of dyshormonal disorders, as well as in the complex therapy of acute and chronic disorders of blood supply to the brain (stroke and cerebrovascular insufficiency). Hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic and hypertensive). Reduced working capacity; mental and physical overload (including athletes). The drug may give a positive result during doping control (see the section “Special instructions”). Withdrawal syndrome in chronic alcoholism (in combination with specific alcoholism therapy).

Contraindications

Hypersensitivity to the components of the drug, increased intracranial pressure (with impaired venous outflow, intracranial tumors), age up to 18 years (efficacy and safety have not been established), pregnancy, breastfeeding. With caution in case of liver and/or kidney diseases.

Side effects

Depending on the frequency of occurrence, the following groups of undesirable side effects are distinguished according to WHO: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare ( 1/10000 to < 1/1000); very rare (Rarely-allergic reactions (redness, rash, itching, edema), as well as dyspeptic phenomena, tachycardia, decreased or increased blood pressure, agitation. Very rarely – eosinophilia, general weakness.

Interaction

It can be combined with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators. Enhances the action of cardiac glycosides. Due to the possible development of moderate tachycardia and hypotension, caution should be exercised when combined with nitroglycerin, nifedipine, alpha-blockers, other antihypertensive agents and peripheral vasodilators, as meldonium enhances their effect.

How to take, course of use and dosage

Due to the possible stimulating effect, the drug is recommended to be used in the first half of the day. The drug is administered intramuscularly, intravenously and parabulbar. The method of use, dose and duration of treatment are set individually depending on the indications, severity of the condition, etc. Cardiovascular diseasesas part of complex therapy: – coronary heart disease (myocardial infarction) intravenously jet 0.5-1.0 g per day (5-10 ml of the drug);- coronary heart disease (stable angina pectoris), chronic heart failure and cardiomyopathy against the background of dyshormonal disorders intravenously jet 0.5-1.0 g per day (5-10 ml of the drug) or intramuscularly 0.5 g 1-2 times a day, the course of treatment is 10-14 days, followed by switching to oral use. The general course of treatment is 4-6 weeks. Disorders of cerebral circulation as part of complex therapy in the acute phase of 0.5 g (5 ml of the drug) 1 time a day intravenously for 10 days, switching to oral use of 0.5-1.0 g. The general course of treatment is 4-6 weeks. For chronic cerebrovascular insufficiency (dyscirculatory encephalopathy),0.5 g (5 ml of the drug) intramuscularly or intravenously 1 time a day for 10 days, then 0.5 g inside. The general course of treatment is 4-6 weeks. Repeated courses (usually 2-3 times a year) are possible after consulting a doctor. Ophthalmopathology (hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic, hypertensive)).0.05 g (0.5 ml of the drug) parabulbarno for 10 days. It is also used in combination therapy. Mental and physical overload-0.5 g (5 ml of the drug) intramuscularly or intravenously 1 time a day. The course of treatment is 10-14 days. If necessary, the course is repeated in 2-3 weeks. Chronic alcoholismmpo 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 turn and separate the valve with rotating movements. 3. Immediately connect the syringe to the ampoule through the resulting hole. 4. Turn the ampoule over and slowly fill the syringe with its contents. 5. Put the needle on the syringe.

Overdose

Symptoms: low blood pressure, accompanied by headache, tachycardia, dizziness and general weakness. Treatment: symptomatic. The drug is low-toxic and does not cause adverse reactions that are dangerous to the health of patients.

Special instructions

Long-term experience in the treatment of acute myocardial infarction and unstable angina in cardiology departments shows that meldonium is not a first-line drug for acute coronary syndrome and its use is not urgently needed. Since January 1,2016, meldonium has been included in the World Anti-Doping Agency’s list of banned substances. Influence on the ability to drive vehicles and mechanismminutes of data on the adverse effect of the drug on the speed of psychomotor reaction.

Form of production

Solution for injection of 100 mg / ml. 5 ml in ampoules made of low-density polyethylene or polypropylene. 5 or 10 ampoules together with the instructions for use in a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of reach of children.

Shelf

life is 4 years. Do not use after the expiration date!

Active ingredient

Meldonium

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection