ETOXYDOL AMPOULES 0.05/ML 2 ML

Clinico-pharmacological group Neurology

Pharmacotherapeutic group Antioxidant

Pharmacy sales terms on prescription

Tradename Ethoxidol®

 International non-proprietary name ethylmethylhydroxypyridine malate

Dosage Form solution for intravenous and intramuscular administration.

Composition on 1 ml: Active substance: ethylmethylhydroxypyridine malate (ethoxydol) - 50 mg. Excipients: N-acetyl-L-glutamic acid - 34 mg, deanol (2- (dimethylamino) ethanol) - 16 mg, Glycine - 0.1 mg, disodium edetate (disodium salt of ethylenediamine-N, N, N ', N '-tetraacetic acid 2-water [Trilon B]) - 0.5 mg, water for injection - up to 1.0 ml.

Pharmacological properties Pharmacodynamics  

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

For intramuscular administration, the drug is determined in the blood plasma for 4 hours after administration. The time to reach the maximum concentration is 0.25 hours. The maximum concentration at a dose of 100 mg is 0.3-1.06 mcg / ml. Etoxydol quickly moves from the bloodstream to organs and tissues and is rapidly eliminated from the body. The retention time of the drug (MRT) is 1.84-2.38 hours. The half-life is 1.15-1.75 h.Ethoxidol is excreted by the kidneys, mainly in the glucuron conjugated form and in small quantities in unchanged form.

Indications for use

- acute disorders of cerebral circulation;

- encephalopathy;

- vegetative dystonia syndrome;

- slight cognitive disorders of atherosclerotic genesis;

- anxiety disorders in neurotic and neurosis-like states;

- relief of withdrawal syndrome in alcoholism with a predominance of neurosis-like and vegetative-vascular disorders;

- acute intoxication with antipsychotics;

Contraindications Hypersensitivity to the drug or its components. Pregnancy, lactation period, age up to 18 years.

Use during pregnancy Etoxidol is contraindicated during pregnancy and lactation, as there are no strictly controlled clinical studies on the safety of the drug during pregnancy and lactation.

Dosage and administration Etoxydol is prescribed intramuscularly and intravenously (jet or drip). When the infusion method of administration of the drug should be diluted in 0.9% sodium chloride solution. Doses are selected individually. Begin therapy with a dose of 50-100 mg 1-3 times a day, gradually increasing to obtain a therapeutic effect. Jet Etoxidol is injected slowly over 5-7 minutes, drip - at a speed of 40-60 drops per minute. The maximum daily dose should not exceed 800 mg.In acute disorders of cerebral circulation, Etoxydol is prescribed in complex therapy for the first 2-4 days intravenously (drip) at a dose of 200-300 mg, then intramuscularly in a dose of 100 mg 3 times a day. Duration of treatment is 10-14 days. When dyscirculatory encephalopathy in the phase of decompensation, ethoxydol is administered intravenously in a stream or drip at a dose of 100 mg 2-3 times a day for 14 days. Then - intramuscularly on 100 mg 2 times a day for 14 days. For course prophylaxis of dyscirculatory encephalopathy, the drug is administered intramuscularly at a dose of 100 mg 2 times a day for 10-14 days. For mild cognitive impairment in elderly patients and for anxiety disorders, the drug is used intramuscularly in a daily dose of 100-300 mg / day for 14-30 days. With alcohol withdrawal syndrome, ethoxydol is administered intramuscularly at a dose of 100-200 mg 2-3 times a day or intravenously drip 1-2 times a day for 5-7 days. In acute intoxication with antipsychotics, the drug is administered intravenously at a dose of 50-300 mg per day for 7-14 days.

Side effect Dryness, "metallic" taste in the mouth, sensations of "overflowing heat" throughout the body, unpleasant smell, sore throat and discomfort in the chest, feeling of lack of air (usually associated with an excessively high rate of administration and are of short duration); with prolonged use - nausea, flatulence; sleep disturbances (drowsiness or sleep disturbance).

Overdose Symptoms: sleep disturbances (insomnia, in some cases drowsiness); with intravenous administration - a slight and short-term (up to 1.5-2 h) increase in blood pressure. Note: as a rule, it is not required - the symptoms disappear on their own within 24 hours. In severe cases of insomnia, nitrazepam 10 mg, oxazepam 10 mg or diazepam 5 mg. With an excessive increase in blood pressure - antihypertensive drugs under the control of blood pressure.

Use with other drugs Enhances the action of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), anti-Parkinsonian drugs (levodopa). 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 the dark place at a temperature of no higher than 25 ° C. Keep out of reach of children.