Alpha-Tocopherol Acetate (Vitamin E) 300 mg/ml

Indications

Prevention of vitamin E deficiency.

Method of administration and doses

Orally.
Prevention of vitamin E deficiency.
Adults and children over 10 years: men - 12.1-15.73 IU/day (5 drops of solution 100 mg/ml or 2 drops of solution 300 mg/ml), women - 7.87-9.68 IU/day (4 drops of solution 100 mg/ml or 1 drop of solution 300 mg/ml), pregnant women - 12.1-15.73 IU/day (5 drops of solution 100 mg/ml or 2 drops of solution 300 mg/ml), breastfeeding mothers - 12.1-15.73 IU/day (5-6 drops of solution 100 mg/ml or 2 drops of solution 300 mg/ml); children under 3 years - 4.84-7.87 IU/day (2-3 drops of solution 100 mg/ml or 1 drop of solution 300 mg/ml), 3-10 years - 7.26-7.86 IU/day (3 drops of solution 100 mg/ml or 1 drop of solution 300 mg/ml).
It should be noted that 1 drop of 100 - 300 mg/ml solution from an eye dropper, dropper bottle, or bottle with a dropper cap contains approximately 2 and 6.5 mg of tocopherol acetate, respectively.

Section: Composition

1 ml contains:
Active ingredient: d,l-alpha-Tocopherol acetate (Vitamin E) - 300 mg
Excipients: Sunflower oil (refined deodorized "First grade" - up to 1 ml
1 mg of d,l-alpha-tocopherol acetate corresponds to 1 IU.

Description of the dosage form

Transparent oily liquid from light yellow to dark yellow in color without a rancid smell. A greenish tint is permissible.

Contraindications

Hypersensitivity to d,l-alpha-Tocopherol acetate or to any of the excipients of the drug.

Severe atherosclerosis of the coronary arteries.

Myocardial infarction.

Increased risk of thromboembolism.

With caution

Hypoprothrombinemia (against the background of vitamin K deficiency - may be exacerbated at doses of vitamin E greater than 400 IU).

Section: Special Instructions

Tocopherols are found in the green parts of plants, especially in the young shoots of cereals; large amounts of tocopherols are found in vegetable oils (sunflower, cottonseed, corn, peanut, soybean, sea buckthorn). Some amount of them is present in meat, fat, eggs, and milk.
It should be noted that newborns with low birth weight may experience vitamin E deficiency due to the low permeability of the placenta (the blood of the fetus contains only 20-30% of the vitamin E concentration found in the mother's blood).

Side effects

Possible allergic reactions.

Section: Overdose

Symptoms: with prolonged intake in doses of 400-800 IU/day (1 mg = 1.21 ME) - blurred vision, dizziness, headache, nausea, unusual fatigue, diarrhea, abdominal pain, asthenia; with intake exceeding 800 IU/day for an extended period - increased risk of bleeding in patients with vitamin K deficiency, disruption of thyroid hormone metabolism, sexual dysfunction, thrombophlebitis, thromboembolism, necrotizing colitis, sepsis, hepatomegaly, hyperbilirubinemia, renal failure, retinal hemorrhage, hemorrhagic stroke, ascites.
Treatment - symptomatic, discontinuation of the drug, administration of glucocorticoids.

Interaction

Enhances the effect of glucocorticosteroids and non-steroidal anti-inflammatory drugs, antioxidants. Increases the effectiveness and reduces the toxicity of vitamins A, D, and cardiac glycosides. The administration of vitamin E in high doses may cause a deficiency of vitamin A in the body. Cholestyramine, colestipol, and mineral oils reduce the absorption of alpha-tocopherol acetate. High doses of iron enhance oxidative processes in the body, increasing the need for vitamin E. The simultaneous use of vitamin E at a dose of more than 400 mg/day with anticoagulants (derivatives of coumarin and indandione) increases the risk of developing hypoprothrombinemia and bleeding. When vitamin E is used simultaneously with cyclosporine, the absorption of the latter is increased.

Section: Pharmacodynamics

Fat-soluble vitamin. Has antioxidant properties (removes toxins from the body), prevents the formation of peroxides (removes and limits their formation from membrane lipids), provides protection for unsaturated fatty acids; participates in the formation of intercellular substance, collagen and elastic fibers of connective tissue, smooth muscle of blood vessels, and the digestive tract. Restores impaired capillary blood circulation, normalizes capillary and tissue permeability, increases tissue resistance to hypoxia.

Pharmacokinetics

Absorption from the duodenum (requires the presence of bile salts, fats, and normal pancreatic function) - 50-80%. Binds to beta-lipoproteins in the blood. In cases of protein metabolism disorders, transport is hindered. Tmax - 4 hours. Deposited in all organs and tissues, especially in adipose tissue. Crosses the placenta in insufficient amounts: 20-30% of the concentration in the mother's blood penetrates into the fetal blood. Passes into breast milk. Metabolized in the liver to derivatives with a quinone structure (some of which have vitamin activity). Excreted in bile - more than 90% (some amount is reabsorbed and undergoes enterohepatic circulation), kidneys - 6% (in the form of glucuronides of tocopheronic acid and its gamma-lactone). Excreted slowly, especially in premature and newborn infants, where accumulation may occur.