Etoxidol, Chewable tablets 100mg, 50pcs

Composition

One tablet contains:

Active ingredient:

ethylmethylhydroxypyridine malate (etoxidol) – 100 mg.

Auxiliary substances:

acetylglutamine acid (N-acetyl-L-glutamic acid) – 68 mg,

deanol (2-dimethylaminoethanol) – 32 mg,

glycine,20 mg,

microcrystalline cellulose – of 260.1 mg,

povidone (kollidon 90F) – 1.6 mg,

lactose monohydrate (milk sugar) – 36 mg,

pregelatinization starch (starch 1500) 30 mg,

silicon dioxide colloid (Aerosil) – 9.5 mg,

magnesium stearate – 6 mg,

croscarmellose sodium (Primerose) – 12,8 mg,

sodium cyclamate – 18 mg,

orange flavor (flavor food Orange) – 6 mg.

Pharmacological action

An antioxidant remedy

ATX Code: C01EB

Pharmacological properties

Pharmacodynamics

Ethoxidol ® is an inhibitor of free radical processes, has a membrane-protective, antihypoxic, nootropic, anticonvulsant, anxiolytic effect, increases the body’s resistance to stress. Etoxidol® it has anti-ischemic properties, improves blood flow in the ischemic zone, limits the area of ischemic damage, detects hypolipidemic action, reduces the content of total cholesterol and low-density lipoproteins.

The drug increases the body’s resistance to various damaging factors, to oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorders, alcohol intoxication and antipsychotic drugs (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 (red blood cells 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 superoxide oxidase, increases the lipid-protein ratio, reduces the viscosity of the membrane, and increases its fluidity.

Modulates the activity of membrane-bound enzymes (calcium 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, transport neurotransmitters, and improve synoptic transmission.

Pharmacokinetics

After oral use, 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 use of Etoxidol ® tablets at a dose of 100 mg, the maximum concentration (cmax) in blood plasma is reached after 0.28±0.08 hours and is 487.0±72.4 ng / ml, followed by rapid elimination of the drug, with a half-life (T_1/2) = 1.46±0.13 hours.

Etoxidol® it is quickly distributed to the organs and tissues of the body. It is determined in the blood plasma for 7-10 hours.

The drug is intensively metabolized in the liver with the formation of phosphate-3-hydroxypyridine, glucuronoconjugated products.

Indications

-ischemic heart disease (as part of complex therapy);

– complex therapy of ischemic stroke;

– dyscirculatory encephalopathy;

– mild and moderate cognitive disorders.

Use during pregnancy and lactation

Ethoxidol is contraindicated during pregnancy and lactation, as strictly controlled clinical studies of the safety of the drug during pregnancy and lactation have not been conducted.

Contraindications

Hypersensitivity to the components of the drug, lactose intolerance, lactase deficiency, glcucose-galactose malabsorption.

Acute hepatic and / or renal failure, pregnancy, lactation, age up to 18 years (efficacy and safety have not been established).

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 disturbance) may occur.

Interaction

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

How to take, course of use and dosage

Etoxidol ® tablets are prescribed orally. 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.

Course – at least 2 months, repeated courses – on the recommendation of a doctor. The duration of treatment and the choice of 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 limiting the duration of treatment in a dose of 100 mg 3-4 times a day.

Overdose

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

Treatment is symptomatic.

Description

Tablets are white or white with a creamy tint of color, flat-cylindrical in shape, with a chamfer and risk; “marbling”, inclusions and some surface roughness are allowed.

Special instructions

During the treatment period, 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 production

Chewable tablets 100 mg.

10 tablets in contour cell packages made of polyvinyl chloride film and aluminum foil printed varnished.

By 10,20,30,40,50,60,70,80,90,100 tablets in polymer cans made of polypropylene, low-pressure polyethylene, capped with stretched lids with control of the first opening or screw-on lids.

Every jar,1,2,3,4,5,6,7,8,9,10 contour cell packages with instructions for use are placed in a pack of cardboard.

Storage conditions

Store in a dark place at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf

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

Active ingredient

Ethylmethylhydroxypyridine malate

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Description

For adults as directed by your doctor

Indications

Prevention of heart attacks and strokes, Consequences of stroke, Atherosclerosis, Exposure to adverse factors, Stress