Meldonium-SOLOfarm - instructions for use, dose, side effects, contraindications

In conditions of increased load meldoon restores the balance between delivery and the need for cells in oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; has also a tonic effect. As a result of its use, the body acquires the ability to withstand the load and quickly restore energy reserves. Thanks to these properties meldoon used to treat various disorders of the cardiovascular system, blood supply to the brain, as well as to improve physical and mental performance.As a result of a decrease in the concentration of carnitine, gamma-butyrobetaine, which has vasodilating properties, is synthesized intensively. In the case of acute ischemic injury of the myocardium meldoon slows the formation of the necrotic zone, shortens the rehabilitation period. With heart failure increases tolerance to physical exertion, reduces the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral circulation improves blood circulation in the ischemic focus, promotes redistribution of blood in favor of the ischemic site. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism with withdrawal syndrome.

Pharmacokinetics:

Bioavailability of the drug after intravenous administration is 100%. The maximum concentration in the blood plasma is achieved immediately after its administration.

Metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life (T1 / 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). Hemophthalmia and hemorrhages in the retina of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic and hypertonic).

Reduced efficiency; mental and physical overload (including athletes). The drug may give a positive result in the doping control (see section "Special instructions").

Syndrome of withdrawal from chronic alcoholism (in combination with specific therapy of alcoholism).

Contraindications:

Hypersensitivity to the components of the drug, increased intracranial pressure (with violation of venous outflow, intracranial tumors), age to 18 years (efficacy and safety not established), pregnancy, the period of breastfeeding.

Carefully:

In diseases of the liver and / or kidney.

Pregnancy and lactation:

The safety of use in pregnant women has not been studied, to avoid possible adverse effects on the fetus, its use is contraindicated. Isolation of the drug with milk and its effect on the health of the newborn have not been studied, therefore, if necessary, use should stop breastfeeding.

Dosing and Administration:

Due to the possible exciting effect of the drug is recommended to use in the morning.

The drug is administered intramuscularly, intravenously and parabulbar.

The method of administration, dose and duration of treatment are set individually, depending on the indications, severity of the condition, etc.

Cardiovascular diseases

As part of complex therapy:

- ischemic heart disease (myocardial infarction) intravenously struino by 0.5-1.0 g per day (5-10 ml of the drug);

- ischemic heart disease (stable angina), chronic heart failure and cardiomyopathy against a background of dyshormonal disorders intravenously struino by 0.5-1.0 g per day (5-10 ml of the drug) or intramuscularly by 0.5 g 1-2 times in day, the course of treatment 10-14 days, with the subsequent transition to oral administration. The general course of treatment is 4-6 weeks.

Disorders of cerebral circulation

In the complex therapy in the acute phase of 0.5 g (5 ml of the drug) 1 time per day intravenously for 10 days, switching to oral intake of 0.5-1.0 g. The general course of treatment is 4-6 weeks.

With chronic cerebral circulatory insufficiency (dyscirculatory encephalopathy), 0.5 g (5 ml of the drug) intramuscularly or intravenously once a day for 10 days, then 0.5 g. The general course of treatment is 4-6 weeks.

Repeated courses (usually 2-3 times a year) are possible after consultation with a doctor.

Ophthalmology (hemophthalmia and hemorrhage into the retina of various etiologies, thrombosis of the central vein of the retina and its branches, retinopathy of various etiologies (diabetic, hypertensive)).

To 0.05 g (0.5 ml of the preparation) is parabulbar for 10 days. Including used in combination therapy.

Mental and physical overloads

For 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

For 0.5 g (5 ml of the drug) intramuscularly or intravenously 2 times a day. The course of treatment is 7-10 days.

The procedure for working with a polymer ampoule:

1.Take an ampoule and shake it, holding it by the neck.

2. Press the ampoule with your hand, while the drug should not be isolated, and rotate and separate the valve with rotating movements.

3. Connect the syringe to the ampoule immediately through the opening.

4. Turn over the ampoule and slowly fill the syringe with its contents.

5. Put the needle on the syringe.

Side effects:

Depending on the frequency of occurrence, the following groups of unwanted adverse reactions are identified by WHO: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/1000); rarely (≥ 1/10000 to <1/1000); very rarely (<1/10000); including individual messages, the frequency is unknown - can not be determined from available data).

Rarely - allergic reactions (redness, rashes, itching, swelling), as well as dyspeptic phenomena, tachycardia, a decrease or increase in blood pressure, agitation.

Very rarely - eosinophilia, general weakness.

Overdose:

Symptoms: lowering blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.

Treatment: symptomatic.

The drug is low in toxicity and does not cause undesirable reactions that are dangerous to the health of patients.

Interaction:

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, other antihypertensive agents and peripheral vasodilators, since meldoon strengthens their action.

Special instructions:

Many years of experience in the treatment of acute myocardial infarction and unstable angina in the cardiology departments shows that meldoon is not a drug of the first series in acute coronary syndrome and its use is not an urgent need.

From 1 January 2016 meldoon is included in the list of banned substances of the World Anti-Doping Agency.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of adverse effects of the drug on the rate of psychomotor reaction.

Form release / dosage:

Solution for injection 100 mg / ml.

Packaging:

5 ml per ampoule of low-density polyethylene or polypropylene.

For 5 or 10 ampoules together with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004194

Date of registration:16.03.2017

Expiration Date:16.03.2022

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp06.04.2017

Illustrated instructions

Instructions

Meldonius-SOLOFARM (Meldonium-SOLOpharm)