Aevit (Capsules) Instructions for Use

ATC Code

A11JA (Vitamins in combination)

Active Substances

Retinol (Rec.INN registered by WHO)

Tocopherol (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Vitamin complex

Pharmacotherapeutic Group

Vitamins; other combined vitamin preparations; combinations of vitamins

Pharmacological Action

A combined medicinal product, the action of which is determined by the properties of the fat-soluble vitamins A and E that are part of it.

Retinol (vitamin A) is a necessary component for the normal function of the retina of the eye: binding with opsin (the red pigment of the retina), it forms the visual purple rhodopsin, which is necessary for visual adaptation in the dark. Vitamin A is necessary for bone growth, normal reproductive function, embryonic development, and for the regulation of division and differentiation of the epithelium (enhances the reproduction of skin epithelial cells, rejuvenates the cell population, and inhibits keratinization processes). Vitamin A participates as a co-factor in various biochemical processes.

The function of α-tocopherol (vitamin E): as an antioxidant, it 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), and prevents hemolysis of erythrocytes. It is a co-factor of some enzyme systems. It restores capillary circulation, normalizes capillary and tissue permeability, and increases tissue resistance to hypoxia.

Pharmacokinetics

Tocopherol when taken orally is slowly absorbed, approximately 50% of the taken dose of the drug, C_max after 4 hours. The presence of bile acids is necessary for absorption. It is deposited in the adrenal glands, pituitary gland, testes, adipose and muscle tissue, erythrocytes, and liver. It is metabolized and excreted from the body (unchanged and in the form of metabolites) with bile (over 90%) and urine (about 6%).

Retinol when taken orally, retinol is absorbed almost completely, even with excessive administration, no more than 10% of the administered amount is excreted with feces. In the process of metabolism, retinyl palmitate, retinol, retinal, and retinoic acid are formed. It is distributed unevenly in the body: the largest amount is in the liver and retina, less is in the kidneys, heart, fat depots, lungs, lactating mammary gland, in the adrenal glands and other endocrine glands. Retinol, retinal, retinoic acid are excreted by hepatocytes as part of bile, retinoylglucuronide is excreted in the urine.

The elimination of fat-soluble vitamins (tocopherol and retinol) is slow, so repeated doses lead to accumulation.

Indications

Hypo- and avitaminosis A and E, as well as conditions of increased body demand for vitamins A and E and/or reduced intake into the body: gastrectomy, diarrhea, steatorrhea, celiac disease, Crohn’s disease, malabsorption syndrome, chronic cholestasis, liver cirrhosis, biliary atresia, obstructive jaundice, cystic fibrosis of the pancreas, tropical sprue, infectious diseases (including chronic and “cold” ones), hemeralopia, xerophthalmia, keratomalacia, inadequate and unbalanced nutrition (including parenteral nutrition), rapid weight loss, nicotine dependence, drug addiction, state of prolonged stress, taking cholestyramine, colestipol, mineral oils, neomycin, iron-containing products, when prescribing a diet with an increased content of polyunsaturated fatty acids, hyperthyroidism.

Peripheral neuropathy, necrotizing myopathy, abetalipoproteinemia.

ICD codes

Dosage Regimen

Take orally. Swallow the capsule whole with a sufficient amount of water.

Adhere strictly to the individual dosing regimen established by a physician. The regimen is determined by the specific indication, severity of the condition, and patient factors.

For the treatment of avitaminosis A and E, the typical adult dose is one capsule (100,000 IU vitamin A, 100 mg vitamin E) per day.

The duration of therapy is determined by the physician. Do not exceed the prescribed daily dose or treatment duration to avoid the risk of hypervitaminosis.

For conditions of increased demand or malabsorption (e.g., post-gastrectomy, chronic cholestasis, cystic fibrosis, Crohn’s disease), the dosage and duration are set individually based on clinical need.

In cases of peripheral neuropathy or necrotizing myopathy, the therapeutic course may be prolonged; follow medical supervision.

This product contains high, therapeutic doses of vitamins and is not intended for prophylactic use or for self-medication without a diagnosis.

Contraindicated in children and adolescents under 18 years of age, during pregnancy, and breastfeeding.

Use with caution in elderly patients and in those with severe liver or renal impairment, thyrotoxicosis, or a history of cholelithiasis.

Adverse Reactions

Systemic reactions allergic reactions.

From the digestive system pain in the epigastric region, dyspeptic disorders (nausea, vomiting, diarrhea); with long-term use in large doses, exacerbation of cholelithiasis and chronic pancreatitis is possible.

Local reactions (with intramuscular injection) – pain, infiltrate, calcification of soft tissues.

Contraindications

Hypersensitivity, hypervitaminosis A and E, childhood (under 18 years), pregnancy, lactation period.

With caution

Thyrotoxicosis, cholecystitis, conditions accompanied by increased vascular permeability (CHF, chronic glomerulonephritis, etc.), liver cirrhosis, viral hepatitis, renal failure, alcoholism, old age, hypoprothrombinemia (against the background of vitamin K deficiency – may be enhanced at a vitamin E dose of more than 400 IU).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

With caution liver cirrhosis, viral hepatitis, renal failure.

Use in Renal Impairment

With caution renal failure, conditions accompanied by increased vascular permeability (CHF, chronic glomerulonephritis, etc.).

Pediatric Use

Contraindicated under the age of 18 years.

Geriatric Use

With caution old age.

Special Precautions

To avoid the development of hypervitaminosis A and E, the recommended doses should not be exceeded.

When using the drug, one should take into account the high content of vitamin A (100 thousand IU) in it, as well as the fact that it is a therapeutic, not a prophylactic drug.

A diet with an increased content of Se and sulfur-containing amino acids reduces the need for vitamin E.

Drug Interactions

Retinol weakens the effect of calcium preparations, increases the risk of hypercalcemia.

Cholestyramine, colestipol, mineral oils, neomycin reduce the absorption of vitamins A and E (an increase in their dose may be required).

Oral contraceptives increase the concentration of retinol in plasma.

Isotretinoin increases the risk of retinol intoxication.

Simultaneous use of tetracycline and retinol in high doses (50 thousand IU and above) increases the risk of intracranial hypertension.

Tocopherol (vitamin E) enhances the effect of corticosteroids, NSAIDs, antioxidants, increases the effectiveness and reduces the toxicity of vitamins A, D, cardiac glycosides. Prescription of vitamin E in high doses can cause deficiency of vitamin A in the body.

Tocopherol (vitamin E) increases the effectiveness of antiepileptic drugs in patients with epilepsy (who have an increased content of lipid peroxidation products in the blood).

Simultaneous use of vitamin E in a dose of more than 400 IU/day with anticoagulants (coumarin and indandione derivatives) increases the risk of hypoprothrombinemia and bleeding.

Use of iron preparations in high doses enhances oxidative processes in the body, which increases the need for vitamin E.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.