Properties
What is it?
Vitamin E Trade Name: Vitamin E International Nonproprietary Name (INN): Tocopherol Dosage Form: Capsules 200 mg and 400 mg Composition: Each capsule contains: Active substance: Alpha-tocopheryl acetate 200 mg and 400 mg Excipients: Sunflower oil Capsule shell composition: Gelatin, Glycerin, Purified water, Sodium benzoate E-211 Description: Oval, soft gelatin capsules, light yellow in color with a seam. Pharmacotherapeutic Group: Vitamins. Other vitamins Indications for Use: Treatment of Vitamin E deficiency. Vitamin E in capsules is not used for the treatment of Vitamin E deficiency conditions associated with malabsorption syndrome. In such cases, parenteral administration of preparations is necessary. Method of Administration and Dosage: The preparation is intended for use by adult patients only. Recommended dosage: Vitamin E 200 mg capsules - 1-2 capsules per day. Vitamin E 400 mg capsules - 1 capsule per day. Maximum daily dose: 800 mg. Capsules should be swallowed whole with a sufficient amount of liquid (preferably 200 ml of water). During or after meals. The duration of treatment depends on the course of the underlying disease. The dose and duration of treatment are determined individually. It is not recommended to take other preparations containing Vitamin E together due to the risk of overdose. Preparations with lower active ingredient content are available for children. Elderly patients do not require dose adjustment. Patients with impaired renal function: Patients with kidney disease should exercise caution when using the preparation. Patients with impaired liver function: Patients with liver disease should exercise caution when using the preparation. If a dose is missed, it should be taken as soon as possible, and the next dose should be taken at the usual time. However, if the next dose is approaching, the missed dose should not be taken. Do not compensate for a missed dose by increasing the next dose. Precautions: Strict adherence to the dosage regimen is necessary. A diet with increased content of selenium and sulfur-containing amino acids reduces the need for Vitamin E. In congenital bullous epidermolysis, gray hair may begin to grow in areas affected by alopecia. With prolonged use of the preparation or the need for repeated courses of therapy, periodic monitoring of blood coagulation parameters, as well as blood cholesterol levels, is recommended. Caution should be exercised in cases of complicated cardiosclerosis, after myocardial infarction, with an increased risk of developing thromboembolism, as well as with hypoprothrombinemia (against the background of Vitamin K deficiency - may be enhanced at doses of Vitamin E above 400 mg). Primary isolated Vitamin E deficiency is rare in the human body. The normal value in adult blood is approximately 9.5 mg/L, which corresponds to 22 µmol/L. Deficiency can be caused by defects in absorption, metabolism, or increased vitamin expenditure during oxidative stress. Deficiency occurs as a result of insufficient intake of vitamins with food, so a balanced diet does not lead to Vitamin E deficiency. The richest sources of Vitamin E are increased grains and most vegetable oils. Other sources include leafy vegetables, animal organs, milk, and cream butter. Assessing Vitamin E intake by the body is difficult, partly due to seasonal variability in Vitamin E content in food products, as well as its loss during storage and preparation. According to national recommendations, the daily requirement of Vitamin E for healthy adults is 15 mg of tocopherol equivalent (1 mg alpha-tocopherol acetate = 0.67 mg tocopherol equivalent). During pregnancy and lactation, an additional 2 to 4 mg of tocopherol equivalent per day is required. In addition, tocopherol requirement increases with insufficient intake of unsaturated fatty acids. Additional requirements also arise with prolonged use of certain medications (e.g., chemotherapy) and with individual diseases (e.g., A-beta-lipoproteinemia). Secondary Vitamin E deficiency in the human body can occur for the following reasons: after gastric resection, celiac disease, enterocolitis, chronic pancreatitis, cystic fibrosis, cholestasis, short bowel syndrome, A-beta-lipoproteinemia, after prolonged parenteral nutrition. Vitamin E deficiency manifests as identified disorders induced by free radicals in cells and tissues, especially in premature infants, such as respiratory distress syndrome, retrolental fibroplasia, and hemolytic anemia. In cases of apparent Vitamin E deficiency, neuromuscular disorders are observed, particularly spinocerebellar degeneration. Oral forms of Vitamin E are not suitable for the treatment of Vitamin E deficiency conditions associated with impaired intestinal absorption. Impaired intestinal absorption can be observed, for example, in cholestasis, A-beta-lipoproteinemia, and in premature infants. In these cases, parenteral administration of the vitamin is necessary. Pregnancy and Lactation: It is well known that there is no clear correlation between maternal and fetal blood Vitamin E concentrations. Short-term intake of Vitamin E by pregnant women before delivery significantly increases Vitamin E status only in the mother. Vitamin E is considered to reach the infant's bloodstream inefficiently from the placenta. The mechanisms regulating placental transfer remain ultimately unstudied; the regulated role of α-TTP in the transfer of α-tocopherol across the placental barrier is likely. Studies involving Vitamin E in animals have not revealed any signs of teratogenic effects. Tocopherol passes into breast milk. Vitamin E intake can be in amounts corresponding to the daily requirement. The recommended daily dose of Vitamin E (tocopherol equivalent) for adults is 15 mg; for pregnant women - 17 mg (from the 2nd half of pregnancy), for nursing mothers - 19 mg. Controlled studies of Vitamin E 200 mg (400 mg) capsules in pregnant women have not been conducted. However, no serious side effects are known to date. The drug should be used with caution during pregnancy. Use of the preparation during lactation is recommended only if the potential benefit outweighs the possible risk to the child. Interactions with Other Medications: Vitamin E increases the effectiveness of anticonvulsants in epileptic patients with increased levels of lipid peroxidation products in the blood. Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine can reduce plasma Vitamin E concentrations. Enhances the effect of steroid and non-steroidal anti-inflammatory drugs, antioxidants. Improves the efficacy of cardiac glycosides, as well as vitamins A and D, and reduces their toxicity. High doses of Vitamin E may cause Vitamin A deficiency in the body. Taking more than 400 mg of Vitamin E per day with anticoagulants (coumarin and indanedione derivatives), antiplatelet agents (clopidogrel and dipyridamole), non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, etc.) increases the risk of hypoprothrombinemia and bleeding. Cholestyramine, cholestipol, mineral oils, isoniazid, orlistat, sucralfate, and olestra fat substitutes reduce the absorption of alpha-tocopheryl acetate. High doses of iron enhance oxidation processes in the body, increasing the body's need for Vitamin E. When alpha-tocopheryl acetate is taken with cyclosporine, the absorption of the latter increases. Very high doses of Vitamin E in animal experiments have shown limited absorption of vitamins A and K. Oral iron preparations can reduce Vitamin E absorption in the intestine when both preparations are taken simultaneously. In this case, it is preferable to take these two preparations at approximately 4-hour intervals. In conditions of malabsorption, combined deficiency of vitamins E and K, as well as when taking vitamin K antagonists (e.g., oral anticoagulants), coagulation should be carefully monitored, as a sharp decrease in vitamin K in the body is possible. Patients undergoing anticoagulant therapy or patients with vitamin K deficiency should not take Vitamin E without strict medical supervision due to the increased risk of bleeding. Side Effects: Allergic reactions. With doses of alpha-tocopherol acetate above 1200 mg (800 mg tocopherol equivalent), creatinuria, gastrointestinal disorders - diarrhea, epigastric pain, nausea, meteorism, increased activity of creatine kinase in blood serum may be observed. Prolonged use of alpha-tocopherol at doses above 600 mg of alpha-tocopheryl acetate per day (400 mg tocopherol equivalent) may lead to a decrease in serum thyroid hormone levels. If any of the described side reactions occur, as well as reactions not indicated in the leaflet, consult a doctor. Overdose: Symptoms: With prolonged use of doses of 400-800 mg/day - blurred vision, dizziness, headache, nausea, unusual fatigue, diarrhea, gastralgia, asthenia; with prolonged intake of doses above 800 mg/day - increased risk of bleeding in patients with K hypovitaminosis, impaired thyroid hormone metabolism, impaired sexual function, thrombophlebitis, thromboembolism, necrotic colitis, sepsis, hematomegalia, hyperbilirubinemia, renal failure, retinal hemorrhages, hemorrhagic stroke, ascites, hemolysis. Treatment: Discontinuation of the preparation; glucocorticoids are prescribed, which accelerate Vitamin E metabolism in the liver; symptomatic agents. Contraindications for Use: Contraindications include: increased individual sensitivity to the components of the preparation; acute myocardial infarction; childhood (for the given dosage form, due to difficulty swallowing capsules in children). Effect on Ability to Drive and Operate Machinery: Does not affect. Packaging: Soft gelatin capsules, 10 capsules in a contour blister pack, 3 contour blister packs for 200 mg dosage and 6 contour blister packs for 400 mg dosage, together with instructions for medical use or leaflet, in a cardboard box. Storage Conditions: Store in a place protected from moisture and light at a temperature of 15°C to 25°C. Keep out of reach of children. Shelf Life: 2 years. Do not use after the expiry date indicated on the packaging. Dispensing Category: Pharmaceutical product group III, available without a prescription.