ETOXIDOL CHEWABLE PILLS 100MG

Clinico-pharmacological group Neurology

Pharmacotherapeutic group Antioxidant

Pharmacy sales terms on prescription

Tradename Ethoxydol

International non-proprietary name ethylmethylhydroxypyridine malate

Dosage Form Pills

Composition

One pill contains:

Active substance: ethyl methyl hydroxypyridine 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 (collidon 90F) - 1.6 mg, lactose monohydrate (milk sugar) - 36 mg, pregelatinized starch (1500 starch) - 30 mg, colloidal silicon dioxide (aerosil) - 9.5 mg, Magnesium stearate - 6 mg, croscarmellose sodium (primelloza) - 12.8 mg, sodium cyclamate - 18 mg, orange flavor (food flavor Orange) - 6 mg.

Pharmacological properties

Pharmacodynamics

Ethoxydol® It is an inhibitor of free radical processes, has a membrane-protective, antihypoxic, nootropic, anticonvulsant, anxiolytic effect, increases the body's resistance to stress. Ethoxydol® has anti-ischemic properties, improves blood flow in the ischemic zone, limits the zone of ischemic damage, detects lipid-lowering 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,

disorders of cerebral circulation, alcohol intoxication 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 membrane structures of blood cells (erythrocytes and platelets) during hemolysis.

The mechanism of action of the drug due to its antioxidant, antihypoxic and membrane-protective action. It inhibits lipid peroxidation, increases the activity of superoxidase, increases the ratio of lipid-protein, reduces the viscosity of the membrane, increases its fluidity. Modulates the activity of membrane enzymes (calcium independent phosphodiesterase, adenylate cyclase, acetylcholinesterase) receptor complexes (benzodiazepine, GABA, acetylcholine) that enhances their ability to bind to ligands, promotes preservation of structural and functional organization of biological membranes, transport of neurotransmitters and improve synaptic transmission.

Pharmacokinetics

After ingestion, it is 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 oral administration of Etoxydol tablets® in a dose of 100 mg, the maximum concentration (C max)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 ½) = 1.46 ± 0.13 hours.

Ethoxydol® quickly distributed to the organs and tissues of the body. Determined in the blood plasma for 7-10 hours.

The drug is extensively metabolized in the liver to form phosphate-3-hydroxypyridine, glucuron conjugated products.

Indications for use

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

- complex therapy of ischemic stroke;

- encephalopathy;

- mild to moderate cognitive impairment.

Contraindications

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

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

Use during pregnancy

Ethoxydol® contraindicated during pregnancy and during breastfeeding, as there are no strictly controlled clinical studies on the safety of the drug during pregnancy and lactation.

Dosage and administration

Tablets Etoxydol® prescribed inside. pills chew and drink water.

For complex therapy of ischemic heart disease and therapy of ischemic stroke, 100 mg (1 tablet) is prescribed 3 times a day, gradually increasing the dose to obtain a therapeutic effect. The maximum single dose - 200 mg; daily - 800 mg. The course is 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.

With the complex therapy of light and moderate cognitive disorders, the drug is prescribed without limiting the course of treatment for a duration of 100 mg 3-4 times a day.

Side effect

Usually the drug is well tolerated. In rare cases, allergic reactions, dyspeptic disorders, nausea and dry mouth, diarrhea, which quickly disappear on their own or with drug withdrawal, may occur. With prolonged use may manifest flatulence, sleep disturbances (drowsiness or sleep disturbance).

Overdose

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

Symptomatic treatment.

Use with other drugs

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

special instructions

During the period of treatment, care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Storage conditions In a dry, dark place, at a temperature not higher than 25 ºС. Keep out of reach of children.