Ethoxydol® (Ethoxidol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceEthyl methylhydroxypyridine malateEthyl methylhydroxypyridine malate
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  • Ethoxydol®
    pills inwards 
    MEDIMPEX, CJSC     Russia
    • Dosage form: & nbspchewing tablets
    Composition:

    1 the tablet contains:

    active substance: ethylmethylhydroxypyridine malate (ethoxydol) 100 mg;

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

    Description:

    Tablets white or white with a creamy shade of color, flat-cylindrical shape with a facet and a risk. It is allowed "marbling", inclusions and some roughness of the surface.

    Pharmacotherapeutic group:antioxidant
    ATX: & nbsp

    N.07.X.X   Other drugs for the treatment of diseases of the nervous system

    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.Ethoxidol® has anti-ischemic properties, improves blood flow in the ischemic zone, limits the area of ​​ischemic damage, reveals lipid-lowering effect, reduces the content of total cholesterol and low-density lipoproteins.

    The drug increases the resistance of the body to the effects of various damaging factors, to oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorders, intoxication with alcohol and antipsychotic drugs (neuroleptics)).

    The drug improves cerebral 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, antihypoxic and membrane-protective action. It inhibits lipid peroxidation, increases the activity of superoxide oxidase, increases the ratio of lipid-protein, reduces the viscosity of the membrane, increases its fluidity. Modulates the activity of membrane-bound enzymes (calcium of independent phosphodiesterase, adenylate cyclase,acetylcholinesterase), receptor complexes (benzodiazepine, GABA, acetylcholine), which enhances their ability to bind to ligands, contributes to the preservation of the structurally functional organization of biomembranes, the transport of neurotransmitters, and the improvement of synaptic transmission.

    Pharmacokinetics:

    After ingestion, quickly 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 the oral administration of tablets Ethoxidol® at a dose of 100 mg, the maximum concentration (C max) in blood plasma is achieved through 0.28 ± 0.08 hours and is 487.0 ± 72.4 ng / ml, followed by a rapid elimination of the drug, with a half-life (T1/2) = 1.46 ± 0.13 hours.

    Ethoxidol® 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 extensively metabolized in the liver to form phosphate-3-hydroxypyridine, glucuronoconjugated products.

    Indications:

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

    - complex therapy of ischemic stroke;

    - encephalopathy;

    - mild to moderate cognitive impairment.

    Contraindications:

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

    Acute hepatic and / or renal failure, pregnancy, lactation, age under 18 (efficacy and safety not established).

    Pregnancy and lactation:

    Ethoxidol® is contraindicated in pregnancy and during breastfeeding, as strictly controlled clinical safety studies of the drug during pregnancy and lactation were not conducted.

    Dosing and Administration:

    Tablets Ethoxydol® is administered orally. Tablets are chewed and washed down with water.

    For complex therapy of coronary heart disease and ischemic stroke therapy, 100 mg (1 tablet) is prescribed 3 times a day, gradually increasing the dose to obtain a therapeutic effect. The maximum single dose is 200 mg; daily - 800 mg. Course - not less than 2 months, repeated courses - on the recommendation of a doctor. Duration of treatment and the choice of individual dose depends on the severity of the patient's condition and the effectiveness of treatment.

    With the comprehensive treatment of pulmonary and moderate cognitive disorders,the drug is prescribed without restriction of the course of treatment for duration in a dose of 100 mg 3-4 times a day.

    Side effects:

    Usually the drug is well tolerated. In rare cases, there may be allergic reactions, dyspeptic disorders, nausea and dry mouth, diarrhea, which quickly disappear on their own or when the drug is withdrawn. With prolonged use, manifestation of flatulence, sleep disturbance (drowsiness or falling asleep) is possible.

    Overdose:

    Due to the low toxicity of the drug, an overdose is unlikely. In case of an accidental overdose, there may be symptoms of sleep disturbance - drowsiness, insomnia.

    Treatment symptomatic.

    Interaction:

    Strengthens the action of antiepileptic drugs (carbamazepine), antiparkinsonian drugs (levodopa) and benzodiazepine anxiolytics.

    Increases antianginal activity of nitro drugs and antihypertensive ACE inhibitors and beta-blockers.

    Reduces the toxic effects of ethyl alcohol.

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

    During the treatment period, care must be taken when driving vehicles and other potentiallydangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets are chewable, 100 mg.

    Packaging:

    10 tablets in a contour mesh box made of a polyvinylchloride film and aluminum foil.

    1,2,5 contour cell packs with instructions for use are placed in packs of cardboard.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002227
    Date of registration:16.09.2013
    Date of cancellation:2018-09-16
    The owner of the registration certificate:MEDIMPEX, CJSC MEDIMPEX, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.10.2015
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