Active substanceVitamin EVitamin E
Dosage form: & nbspsolution for oral administration (oily)
Composition:
Active substance: dl-alpha-Tocopherol acetate - 100 g and 300 g;
auxiliary substance: Sunflower oil (refined deodorized "First grade") - up to 1 liter.
Description:Transparent oily liquid from light yellow to dark yellow without rancid smell. A greenish shade is allowed.
Pharmacotherapeutic group:Vitamin
ATX: & nbsp

A.11.H.A.03   Tocopherol (vitamin E)

Pharmacodynamics:

Fat-soluble vitamin. As an antioxidant, inhibits the development of free radical reactions, prevents the formation of peroxides that damage cellular and subcellular membranes, which is important for the development of the body, the normal function of the nervous and muscular systems. Together with selenium, it inhibits the oxidation of unsaturated fatty acids (a component of the microsomal electron transfer system), prevents the hemolysis of erythrocytes. It is a cofactor of some enzyme systems.

Pharmacokinetics:

Absorption from the duodenum (requires the presence of bile salts, fats, normal function of the pancreas) - 50-80%. It binds to the beta-lipoproteins of the blood. If there is a violation of protein metabolism, transport is difficult. TSmah - 4 hours. It is deposited in all organs and tissues, especially in adipose tissue.Penetrates through the placenta in insufficient quantities: the fetal blood penetrates 20-30 % of blood concentration mother. Penetrates into breast milk. Metabolised in the liver to derivatives that have a quinone structure (some of them have vitamin activity). It is excreted with bile - more than 90% (some amount is again absorbed and subjected to enterohepatic circulation), kidneys - 6% (in the form of glucuronides of tocopheronic acid and its gamma-lactone). It is withdrawn slowly, especially in preterm and newborns, in whom its cumulation is possible.

Indications:Prevention of hypovitaminosis E.
Contraindications:Hypersensitivity to the drug, severe coronary artery atherosclerosis; myocardial infarction, increased risk of thromboembolism.
Carefully:Hypoprothrombinemia (against a background of vitamin K deficiency - may increase with a dose of vitamin E more than 400 ME).
Pregnancy and lactation:On the recommendation of a doctor.
Dosing and Administration:

Inside.

Adults and children from 10 years: men - 10 mg / day, women - 8 mg / day; children under 3 years of age-3 mg / day; 3-10 years - 7 mg / day.

Doses and duration of treatment of hypovitaminosis E are individual and depend on the severity of the condition.It should be borne in mind that 1 drop of 10-30% of 1 solution from the eye dropper contains about 2 and 6.5 mg. tocopherol acetate respectively.

Side effects:

Allergic reactions. The use of large doses of the drug can cause dyspeptic disorders, decreased performance, weakness, thrombophlebitis, thromboembolism of pulmonary arteries, thromboses, increased activity of creatine kinase, creatinuria, hypercholesterolemia, white hair growth in alopecia bladdered epidermolysis.

Overdose:

Symptoms: when taken for a long period in doses of 400-800 units / day. (1 mg = 1.21 ME) - blurred vision, dizziness; headache, nausea, unusual fatigue, diarrhea, gastralgia, asthenia; when taking more than 800 units / day. for a long period - an increased risk of bleeding in patients with hypovitaminosis K, a disorder in the metabolism of thyroid hormones, disorders sexual function, thrombophlebitis, thromboembolism, necrotic colitis, sepsis,hepatomegaly, hyperbilirubinemia, renal failure, hemorrhage into the retina, hemorrhagic stroke, ascites.

Treatment - symptomatic, withdrawal of the drug, the appointment of glucocorticoid funds.
Interaction:The appointment of vitamin E in high doses can cause vitamin A deficiency in the body. Mineral oils reduce absorption. High doses of iron increase oxidative processes in the body, which increases the need for vitamin E.
Special instructions:

According to the approved norms of physiological needs for energy and nutrients for different population groups of the Russian Federation from 2008, the need for vitamin E for children: up to 6 months - 3 mg, from 6 months to 3 years - 4 mg, from 3 to 7 years - 7 mg, from 7 to 11 years - 10 mg, from 11 to 14 years - 12 mg, from 14 to 18 years -15 mg. Adults - 15 mg / kg. The maximum daily intake is 300 mg / day.

Tocopherols are found in green parts of plants, especially in young sprouts of cereals; large amounts of tocopherols found in vegetable oils (sunflower, cottonseed, corn, peanut, soybean, sea buckthorn). Some of them are found in meat, fat, eggs, milk.

It should be borne in mind that in newborns with low body weight, hypovitaminosis E may occur due to low permeability of the placenta (fetal blood contains only 20-30% of vitamin E from its concentration in the mother's blood).

Currently, the effectiveness of vitamin E is considered unreasonable in the treatment and prevention of the following diseases: beta-thalassemia, cancer diseases, fibrosa-cystic dysplasia of the breast, inflammatory skin diseases, hair loss, habitual miscarriage, heart disease, intermittent claudication, postmenopausal syndrome, infertility, peptic ulcer, sickle cell anemia, burns, porphyria, disorders of the nervous traction, thrombophlebitis, impotence, bee stings, senile lentigo, bursitis, diaper dermatitis, pulmonary intoxication with atmospheric pollution, atherosclerosis, aging. The use of vitamin E to increase sexual activity is considered unproven.

Effect on the ability to drive transp. cf. and fur:There is no information.
Form release / dosage:

Solution for oral administration [oily].

Packaging:For 10, 15, 20, 25, 30, 50 and 100 ml of the drug in orange glass vials with a screw neck, or in polymeric bottles.

For 50 and 100 ml of the drug in cans or bottles of orange glass.

To 10, 15, 25, 50 ml in bottles-droppers from orange glass

Each bottle, a dropper, a jar, along with instructions for use, are placed in a pack of cardboard. For hospitals it is allowed to pack bottles, bottles-droppers, cans in a group package (carton box) with an equal number of instructions for use.

Storage conditions:

In dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date indicated on the label.

Terms of leave from pharmacies:Without recipe
Registration number:LP-001439
Date of registration:18.01.2012
Expiration Date:18.01.2017
The owner of the registration certificate:SAMARAHEDPROM, JSC SAMARAHEDPROM, JSC Russia
Manufacturer: & nbsp
Representation: & nbspSAMARAHEDPROM, JSCSAMARAHEDPROM, JSC
Information update date: & nbsp17.07.2017
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