Expiration date: 03/2028

Composition

One tablet contains: Active ingredient: ethylmethylhydroxypyridine malate (ethoxidol) - 100 mg.

Auxiliary substances: acetylglutamic acid (N-acetyl-L-glutamic acid) - 68 mg, deanol (2-dimethylaminoethanol) - 32 mg, glycine - 20 mg, microcrystalline cellulose - 260.1 mg, povidone (collidone 90F) - 1.6 mg, lactose monohydrate (milk sugar) - 36 mg, pregelatinized starch (starch 1500) - 30 mg, colloidal silicon dioxide (aerosil) - 9.5 mg, magnesium stearate - 6 mg, croscarmellose sodium (primellose) - 12.8 mg, sodium cyclamate - 18 mg, orange flavor (food flavor "Orange") - 6 mg.

Dosage form

Pills

Description

Tablets are white or white with a creamy tint, flat-cylindrical in shape with a chamfer and a risk. Marbling, inclusions, and some surface roughness are allowed.

Pharmacodynamics

Ethoxidol® is an inhibitor of free radical processes, has membrane-protective, antihypoxic, nootropic, anticonvulsant, anxiolytic effects, increases the body's resistance to stress. Ethoxidol® has anti-ischemic properties, improves blood flow in the ischemic zone, limits the zone of ischemic damage, detects a hypolipidemic effect, reduces the content of total cholesterol and low-density lipoproteins. The drug increases the body's resistance to the effects of various damaging factors, to oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulatory disorders, intoxication with alcohol and antipsychotics (neuroleptics)). The drug improves brain metabolism and blood supply to the brain, improves microcirculation and rheological properties of blood, reduces platelet aggregation. Stabilizes the membrane structures of blood cells (erythrocytes and platelets) during hemolysis. The mechanism of action of the drug is due to its antioxidant, antihypoxant and membrane-protective effects. It inhibits lipid peroxidation, increases the activity of superoxidase, increases the lipid-protein ratio, reduces the viscosity of the membrane, increases its fluidity. It modulates the activity of membrane-bound enzymes (calcium independent phosphodiesterase, adenylate cyclase, acetylcholinesterase), receptor complexes (benzodiazepine, GABA, acetylcholine), which enhances their ability to bind to ligands, helps preserve the structural and functional organization of biomembranes, neurotransmitter transport, and improve synaptic transmission.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract at an average rate of 0.569 ± 0.086 h-1. In healthy volunteers, it was found that with oral administration of Ethoxidol® tablets at a dose of 100 mg, the maximum concentration (cmax) in blood plasma is reached after 0.28±0.08 hours and amounts to 487.0±72.4 ng/ml, followed by rapid elimination of the drug, with a half-life (T ?) = 1.46±0.13 hours. Ethoxidol® is rapidly distributed to organs and tissues of the body. It is detected in blood plasma for 7-10 hours. The drug is extensively metabolized in the liver to form phosphate-3-hydroxypyridine, glucuronoconjugated products.

Indications for use

• coronary heart disease (as part of complex therapy);
• complex therapy of ischemic stroke;
• dyscirculatory encephalopathy;
• mild and moderate cognitive disorders.

Contraindications

Hypersensitivity to the components of the drug, lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Acute liver and/or kidney failure, pregnancy, lactation, age up to 18 years (efficacy and safety have not been established).

Use during pregnancy and lactation

Ethoxidol® is contraindicated during pregnancy and lactation, as there have been no strictly controlled clinical studies on the safety of the drug during pregnancy and lactation.

Side effects

The drug is usually well tolerated. In rare cases, allergic reactions, dyspeptic disorders, nausea and dry mouth, diarrhea may occur, which quickly disappear on their own or when the drug is discontinued. With prolonged use, flatulence, sleep disorders (drowsiness or sleep disorders) may occur.

Interaction

Enhances the effect of antiepileptic drugs (carbamazepine), antiparkinsonian drugs (levodopa) and benzodiazepine anxiolytics. Increases the antianginal activity of nitropreparations and the antihypertensive activity of ACE inhibitors and beta-blockers. Reduces the toxic effects of ethyl alcohol.

Method of administration and dosage

Ethoxidol® tablets are prescribed orally. The tablets are chewed and washed down with water. For complex therapy of coronary heart disease and therapy of ischemic stroke, 100 mg (1 tablet) is prescribed 3 times a day, gradually increasing the dose until a therapeutic effect is obtained. The maximum single dose is 200 mg; the daily dose is 800 mg. The course is at least 2 months, repeated courses are recommended by a doctor. The duration of treatment and the choice of an individual dose depends on the severity of the patient's condition and the effectiveness of treatment. In the complex therapy of mild and moderate cognitive disorders, the drug is prescribed without limitation of the course of treatment in a dose of 100 mg 3-4 times a day.

Overdose

Due to the low toxicity of the drug, an overdose is unlikely. In case of accidental overdose, symptoms of sleep disorders may occur – drowsiness, insomnia.

The treatment is symptomatic.

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of release

100 mg chewable tablets. 10 tablets each in a contoured cell package made of polyvinyl chloride film and aluminum foil printed varnished. 1, 2, 5 contour cell packages with instructions for use are placed in cardboard packs.

Storage conditions

In a dry place protected from light, at a temperature not exceeding 25 ° C. Keep out of reach of children

Expiration date

3 years. Do not use after the expiration date indicated on the package.