Vitamin e

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAMIN E (Vitamin E)

Composition:

Active ingredient: 1 capsule contains vitamin E 100 mg, or 200 mg, or 400 mg;

Excipients: sunflower oil; capsule shell: gelatin, glycerin, carmoisine (E 122).

Pharmaceutical form. Soft capsules.

Main physicochemical properties:

Capsules 100 mg: soft gelatin capsules, spherical or round-shaped, with a seam, from light red to dark red in color, filled with oily liquid ranging from light yellow to dark yellow;

Capsules 200 mg: soft gelatin capsules, cylindrical in shape with hemispherical ends, with a seam, from light red to dark red in color, filled with oily liquid ranging from light yellow to dark yellow;

Capsules 400 mg: soft gelatin capsules, oval-shaped, with a seam, red in color, filled with a transparent oily liquid from colorless to slightly greenish-yellow.

Pharmacotherapeutic group. Simple vitamin preparations. Tocopherol (Vitamin E).

ATC code A11HA03.

Pharmacological Properties

Pharmacodynamics

Vitamin E is a fat-soluble vitamin that exerts significant antioxidant and radioprotective effects and participates in heme and protein biosynthesis, cell proliferation, and other vital cellular metabolic processes.

Vitamin E improves tissue oxygen utilization. It produces an angioprotective effect by influencing vascular tone and permeability, stimulating the formation of new capillaries.

The immunomodulatory effect of vitamin E is due to stimulation of T-cell-mediated and humoral immunity.

Tocopherol is essential for normal reproductive processes: fertilization, fetal development, and formation and functioning of the reproductive system.

Vitamin E deficiency leads to hypotonia and dystrophy of skeletal muscles and myocardium, increased capillary permeability and fragility, and degeneration of photoreceptors, which may result in visual disturbances. Reduced sexual function in men and menstrual cycle disorders, as well as increased risk of miscarriage in women, may also develop.

Vitamin E deficiency may lead to hemolytic jaundice in newborns, as well as malabsorption syndrome and steatorrhea.

Pharmacokinetics

After intestinal absorption, most of the tocopherol enters the lymph and blood, rapidly distributing throughout body tissues with predominant accumulation in the liver, muscles, and adipose tissue. The highest concentrations are observed in the adrenal glands, pituitary gland, sex glands, and myocardium. The majority of the drug is excreted from the body in urine, partially via bile.

Clinical characteristics.

Indications.

Hypovitaminosis and avitaminosis of vitamin E. In complex antioxidant therapy, during the period of convalescence after injuries, severe somatic diseases, under physical overexertion, and in cases of unbalanced nutrition.

As part of complex therapy:

• for prevention of embryonal developmental disorders and congenital anomalies (developmental defects) of the fetus;
• threatened miscarriage;
• menstrual cycle disorders, vulvar kraurosis, climacteric disorders;
• perceptual hearing disorders;
• atrophic processes in the mucous membrane of the respiratory tract;
• degenerative and proliferative changes in joints and fibrous tissue of the spine and large joints; muscle weakness due to discogenic blockages in intervertebral disc diseases, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, and other connective tissue diseases;
• neurasthenia with exhaustion, predominantly muscular dystrophy and muscle atrophy, secondary muscle weakness and myopathy in chronic arthritis;
• vegetative disorders;
• certain endocrine disorders;
• certain cardiovascular diseases;
• atrophic processes in the mucous membrane of the gastrointestinal tract, nutritional disorders, malabsorption syndrome, alimentary anemia, chronic hepatitis;
• certain periodontopathies;
• eye diseases;
• skin diseases: dermatitis, trophic ulcers, psoriasis, eczema;
• in cases of penile plastic induration, balanitis, libido disorders, dysfunction of sex glands in males, disorders of spermatogenesis and potency in males, infertility (in combination with vitamin A).

Hypervitaminosis A and D.

Contraindications.

Increased individual sensitivity to the active substance or to any component of the drug, pronounced cardiac sclerosis, acute myocardial infarction, thyrotoxicosis, hypervitaminosis E, children under 12 years of age.

Interaction with other medicinal products and other types of interactions.

Vitamin E should not be used together with iron or silver preparations, alkaline agents (sodium hydrocarbonate, trisamin), or indirect-acting anticoagulants (dicoumarin, neodicoumarin).

Vitamin E enhances the effect of steroid and non-steroidal anti-inflammatory drugs (sodium diclofenac, ibuprofen, prednisolone); reduces the toxic effect of cardiac glycosides (digoxin, digitoxin), and vitamins A and D. Administration of high doses of vitamin E may cause vitamin A deficiency in the body.

Vitamin E and its metabolites exert antagonistic action towards vitamin K.

Vitamin E increases the efficacy of antiepileptic drugs in patients with epilepsy.

Cholestyramine, colestipol, and mineral oils reduce the absorption of vitamin E.

Special precautions.

Use with caution in patients with atherosclerosis and an increased risk of thromboembolism.

Rarely observed: creatinuria, increased creatine kinase activity, elevated cholesterol levels, thrombophlebitis, pulmonary artery thromboembolism, and thrombosis in predisposed patients. In areas affected by alopecia in patients with epidermolysis bullosa, white hair growth may occur.

When using the drug, it is necessary to strictly adhere to the dosage and duration of treatment prescribed by the physician in order to prevent overdose and the development of vitamin E hypervitaminosis.

With prolonged use of high doses of the drug, blood coagulation time should be monitored.

Use during pregnancy or breastfeeding.

The drug may be used under medical supervision at recommended doses during pregnancy or breastfeeding.

The drug partially crosses the placental barrier; vitamin E enters the fetal circulation, where its concentration amounts to 20–30% of the vitamin E concentration in maternal plasma.

Vitamin E also passes into breast milk.

Ability to influence reaction speed when driving or operating machinery.

If dizziness or blurred vision occurs, avoid driving or operating machinery.

Method of Administration and Dosage

Vitamin E should be administered orally after meals. The dosage should be individually selected depending on the type of disease, disease course, and patient's condition. The capsule should be swallowed whole with a sufficient amount of water.

Dosage for adults:

• in complex antioxidant therapy: 200–400 mg 1–2 times daily;
• in embryonic developmental pathology, congenital abnormalities (birth defects) of the fetus: 100–200 mg once daily during the first trimester of pregnancy;
• in threatened miscarriage: 100 mg 1–2 times daily for 14 days;
• in menstrual cycle disorders as part of combination therapy: 300–400 mg every other day, starting from day 17 of the cycle (repeat for 5 cycles);
• in menstrual cycle disorders when the drug is used prior to initiation of hormonal therapy: 100 mg 1–2 times daily for 2–3 months;
• in rheumatoid arthritis: 100–300 mg daily for several weeks;
• in muscular dystrophies, diseases of the neuromuscular and tendinous-articular apparatus: 100 mg 1–2 times daily for 30–60 days; repeat course after 2–3 months;
• in neurasthenia with exhaustion: the drug should be taken at a dose of 100 mg once daily for 30–60 days;
• in certain endocrine disorders: 300–500 mg daily;
• in certain cardiovascular diseases: 100 mg daily;
• in nutritional anemia: 300 mg daily for 10 days;
• in chronic hepatitis: 300 mg daily for a prolonged period;
• in certain periodontopathies: 200–300 mg daily;
• in eye diseases: 100–200 mg 1–2 times daily for 1–3 weeks in combination with vitamin A;
• in skin diseases: 100–200 mg 1–2 times daily for 20–40 days;
• in penile plastic induration: 300–400 mg daily for several weeks, then as directed by physician;
• in impaired spermatogenesis and potency in men: 100–300 mg daily in combination with hormone therapy for 30 days.

In other cases, dosage and duration of treatment are determined by the physician.

For adults, the average single dose is 100 mg, the maximum single dose is 400 mg; the average daily dose is 200 mg, the maximum daily dose is 1000 mg.

Vitamin E at a dose of 100 mg may be prescribed to children aged 12 years and older.

Children. The drug is contraindicated in children under 12 years of age.

Overdose.

Symptoms. Adverse reactions do not occur when recommended doses are taken. Intake of high doses of vitamin E (400–800 mg daily for a prolonged period) may cause visual disturbances, diarrhea, dizziness, headache, nausea or abdominal cramps, extreme fatigue or weakness.

Very high doses (over 800 mg daily for a prolonged period) may lead to an increased risk of bleeding in patients with vitamin K deficiency; disturbances in thyroid hormone metabolism and increased risk of thrombophlebitis and thromboembolism in susceptible patients, increased creatine kinase activity, increased serum cholesterol and triglyceride concentrations, and increased urinary excretion of estrogens and androgens.

Treatment. Discontinuation of the drug, symptomatic therapy.

Adverse reactions.

The drug is usually well tolerated; however, with prolonged use of high doses ranging from 400 mg to 800 mg per day, the following may occur: increased hypotrombinemia, visual disturbances, dizziness, nausea, development of gastrointestinal bleeding, diarrhea, stomach pain, liver enlargement, creatinuria, digestive disorders, increased fatigue, general weakness, and headache. Allergic reactions are possible, including skin rashes, itching, skin redness, and fever.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

100 mg capsules. 10 capsules in blisters. 10 capsules per blister; 1 blister per pack. 10 capsules per blister; 3 blisters per pack. 10 capsules per blister; 5 blisters per pack. 20 capsules per blister; 1 blister per pack. 20 capsules per blister; 2 blisters per pack. 20 capsules per blister; 3 blisters per pack. 50 capsules per blister; 1 blister per pack.

200 mg capsules. 10 capsules in blisters. 10 capsules per blister; 3 blisters per pack.

400 mg capsules. 10 capsules per blister; 1 blister per pack. 10 capsules per blister; 3 blisters per pack.

Availability. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business operations.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.