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Dosage form: & nbspsolution for intravenous and intramuscular administration
Composition:

Composition per 1 ml:

active substance: ethylmethylhydroxypyridine malate (ethoxydol) 50 mg;

Excipients: acid N-acetyl-L-glutamine 34 mg, deanol (2- (dimethylamino) ethanol) 16 mg, glycine 0.1 mg, disodium edetate (disodium ethylenediamine-N, N, N', N'-tetraacetic acid 2-water [Trilon B]) 0.5 mg, water for injection up to 1.0 ml.

Description:Colorless or yellowish-brownish transparent liquid.
Pharmacotherapeutic group:antioxidant
ATX: & nbsp
  • 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 possesses 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, ischemia, cerebral circulation disorders, intoxication with alcohol and antipsychotic drugs (neuroleptics)).Ethoxidol is able to modulate the functional metabolic state of erythrocytes, to correct the functional status of the liver and kidneys. By restoring the activity of synthesis of the macroergic metabolite of 2,3-diphosphoglycerate, the preparation increases the dissociation of oxyhemoglobin and restores the oxygen tension. The effectiveness of this drug in encephalopathies is due to an increase in oxygen in the arterial blood; penetration of ethoxidol through the blood-brain barrier.

    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 dismutase, reduces the content of total organic peroxides, thereby facilitating the acceleration of aldosterone metabolism (by normalizing the activity of the isoenzyme CYP3A4), increases the ratio of lipid-protein, reduces the viscosity of the membrane, increases its fluidity.By suppressing peroxides and oxidant activity, it blocks oxidation β-Lipoproteins (low-density lipoproteins), which are the main substrate for the formation of atherosclerotic plaques in the vessels. 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, promotes preservation of the structural and functional organization of biomembranes, neurotransmitter transport and improves synaptic transmissions.

    Pharmacokinetics:

    With intramuscular injection ethylmethyl hydroxypyridine malate is determined in the blood plasma for 4 hours after the 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 μg / ml. Ethyl methylhydroxypyridine malate quickly passes from the bloodstream into organs and tissues and is quickly eliminated from the body. The retention time of ethylmethylhydroxypyridine malate (MRT) is 1.84-2.38 hours. The half-life is 1.15-1.75 h. Ethyl methylhydroxypyridine malate is excreted from the body by the kidneys, mainly in glucuronoconjugate form and in small amounts in unchanged form.

    Indications:

    - Acute disorders of cerebral circulation;

    - encephalopathy;

    - syndrome of vegetative dystonia;

    - light cognitive disorders of atherosclerotic origin;

    - anxiety disorders in neurotic and neurosis-like states;

    - relief of withdrawal syndrome with alcoholism with prevalence of neurosis-like and vegetative-vascular disorders;

    - acute intoxication with antipsychotic drugs.

    Contraindications:

    Hypersensitivity to the drug or its components.

    Sharp hepatic and / or renal failure, pregnancy, lactation, age under 18 years.

    Carefully:

    Allergic diseases and reactions in the anamnesis.

    Pregnancy and lactation:

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

    Dosing and Administration:

    Ethoxidol is administered intramuscularly and intravenously (either jet or drip). With the infusion method of administration, the drug should be diluted in a 0.9% solution of sodium chloride. 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. Inject Etoxidol slowly for 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 Ethoxidol is prescribed in complex therapy in the first 2-4 days intravenously (drip) at a dose of 200-300 mg, then intramuscularly at 100 mg 3 times a day. Duration of treatment is 10-14 days.

    With discirculatory encephalopathy in the phase of decompensation and the syndrome of autonomic dystonia Ethoxidol is administered intravenously in a stream or drip in a dose of 100 mg 2-3 times a day for 14 days, then intramuscularly at 100 mg twice a day for 14 days.

    For the course of prophylaxis of dyscirculatory encephalopathy the drug is administered intramuscularly at a dose of 100 mg twice a day for 10-14 days.

    In light cognitive disorders of atherosclerotic genesis and with anxiety disorders in neurotic and neurosis-like states the drug is used intramuscularly in a daily dose of 100-300 mg / day for 14-30 days.

    When cupping abstinence syndrome with alcoholism with a predominance of neurosis-like and vegetative-vascular disorders Ethoxidol is administered intramuscularly in a dose of 100-200 mg 2-3 times a day or intravenously drip 1-2 times a day for 5-7 days.

    When acute intoxication with antipsychotic agents Ethoxidol is administered intravenously at a dose of 50-300 mg per day for 7-14 days.

    Side effects:

    Dryness, "metallic" taste in the mouth, sensation of "spilling heat" throughout the body, sore throat and chest discomfort, feeling of lack of air (usually associated with an excessively high rate of administration and short-term); with prolonged use - nausea, flatulence; sleep disturbances (drowsiness or falling asleep).

    Overdose:

    Symptoms: sleep disorders (insomnia, in some cases, drowsiness); at intravenous introduction - insignificant and short-term (up to 1,5-2 ch) increase of arterial pressure.

    Treatment: as a rule, is not required - the symptoms disappear on their own within 24 hours. In severe cases with insomnia - nitrazepam 10 mg, oxazepam 10 mg or diazepam 5 mg. With increasing blood pressure - hypotensive drugs under the control of blood pressure.

    Interaction:

    Enhances the action of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), antiparkinsonian drugs (levodopa).

    Reduces the toxic effects of ethyl alcohol.

    Special instructions:

    During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 50 mg / ml.

    Packaging:

    By 2 ml or 5 ml into neutral glass ampoules of grade НС-1 or НС-3 or light-protective glass СНС-1 or СНС-3.

    10 ampoules are placed in a box of cardboard.

    5 ampoules are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered or foil-free.

    1, 2 contour mesh packages are placed in a pack of cardboard.

    In each pack, a box of instructions for use, a scarifier ampoule.

    When using ampoules with a kink ring or with a notch and a dot the ampoule scaper is not inserted.

    Storage conditions:

    In 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 expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008593/10
    Date of registration:23.08.2010 / 30.10.2013
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp10.10.2015
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