a-tocopherol acetate (vitamin E) (50 % solution in oil in capsules of 0,2 g)

Solutioa-Tocopheroli acetatis (Vitamini E) oleosa

International nonproprietary name

Vitamin E.

Vitamin E.

Pharmacotherapeutic group

The agents influencing on metabolic processes. Vitamin preparations.

Composition of the preparation

1 capsule contains 100 mgof a-tocopherolacetate (200 mg of 50 % of a-tocopherol acetate oil solution).

Pharmacological action

Pharmacodynamics

The preparation fills up vitamin E deficiency. Possess an antioxidant activity. Participates in processes of tissue metabolism, prevents erythrocytes hemolysis, prevents capillaries permeability and fragility increase, disorder of testicular tubules and testicles function, placentas, and normalizes reproductive function. Prevents from atherosclerosis development, degenerate-dystrophic changes in cardiac muscle and skeletal musculature. Improves energy supply and contractile ability of myocardium, reduces consumption of oxygen by myocardium. Inhibits free radical reactions, prevents formation of peroxides, damaging cellular and subcellular membranes. Stimulates synthesis of heme and heme-containing enzymes - hemoglobin, myoglobin, cytochromes, catalase, peroxidase. Improves tissue respiration, stimulates synthesis of proteins (collagen, enzymatic, structural and contractile proteins sceletal and unstriated muscles, myocardium), protects from vitamin A oxidation. Inhibits of oxidation of nonsaturated fat acids and selenium (a component of microsomal systems of electron transfer). Inhibits synthesis of cholesterin.

Pharmakokinetics

Approximately 50 % of the administration dose of preparation are slowly absorbed after it intake, the maximum level in blood is reached in 4 h. The presence of bile acids is necessary for absorption. It is deposited in adrenals, pituitary body, testicles, fatty and muscular tissue, erythrocytes, liver. It is exposed to metabolism and is eliminated from an organism (in an unchanged form and in the form of metabolites) with bile (over 90 %) and urine (about 6 %).

Indications

Hypovitaminosis, muscular dystrophia, degenerative changes of ligamentous apparatus (including vertebral column), joints and muscles, posttraumatic and postinfectious secondary myopathy, dermatomyositis, condition of reconvalescence after the diseases proceeding with feverish syndrome, dysmenorrhea, threatened abortion, climacterium, hypofunction of sexual glands in men, asthenic and neurasthenic syndrome, neurasthenia at overwork, lupus erythematosus, scleroderma, rheumatoid joint inflammation, myocardial dystrophy, spasm of peripheric vessels, atherosclerosis, idiopathic hypertensia, cardiovascular collapse, stenocardia, diseases of liver, dermatoses, trophic ulcers, psoriasis, elderly age, hypotrophy.

Dosage and method of administration

The preparation is administrated per orally to the adults in doses of 100-300 mg (1-3 capsules) a day.

At neuromuscular diseases (the muscular dystrophia, amyotrophic lateral sclerosis and so on) should be administrated per 100 mg a day (1 capsule) for 1-2 months. Repeated courses are carried out in 2-3 months.

To men at spermatogenesis and potency disorders should be administrated  per 100-300 mg a day (1-3 capsules) in combination with hormonal therapy for a month.

At threatened abortion should be administrated  per 100 mg a day (1 capsule) for 7-14 days.

At habitual abortion and aggravation of fetal development should be administrated per 100 mg a day (1 capsule) in the first 2-3 months of pregnancy daily or every other day.

At diseases of peripheric vessels, myocardial dystrophies, atherosclerosis should be administrated per 100 mg a day (1 capsule) in a combination with vitamin A. Duration of course is 20-40 days it is possible to repeat course of treatment in 3-6 months.

At diseases of a skin should be administrated per 100 mg a day (1 capsule) for 20-40 days.

Side effects

There can be allergic reactions at preparation intake. Dyspepsia, creatinuria are possible in case of long application of high dosesof a-tocopherolacetate. At occurrence of side effects it is necessary to reduce dose of the preparation or withdraw it.

Contraindications

Contraindications are: hypersensitivity, cardiosclerosis, myocardial infarction.

Should be administrated with special care at increased risk of thromboembolism development.

Interactions with other medicinal preparations

Strengthens effect of steroid and nonsteroid antiinflammatory drugs, cardiac glycosides, reduces toxicity of the last, and also vitamins A and D.

Overdosage

Declared as creatinuria, diarrhea, pains in epigastrium, depression of working capacity.

The form of release

The soft gelatinous capsules containing 100 mgofa-tocopherol acetate (200 mg of 50 % Solutio oleosa of a-tocopherol acetate). 15, 25, 50 capsules in containers, 10 capsules in a blister.