Instructions for Aevit soft capsules blister No. 60
Composition
active ingredients: 1 capsule contains vitamin A 100,000 IU; vitamin E 100 mg;
excipient: sunflower oil;
capsule shell: gelatin, glycerin.
Dosage form
Soft capsules.
Main physicochemical properties: soft gelatin capsules of spherical or spherical shape, with a seam, from yellow to light brown in color, filled with an oily liquid from light yellow to dark yellow in color.
Pharmacotherapeutic group
Combined vitamin preparations. ATX code A11 JA.
Pharmacological properties
Pharmacodynamics
The properties of the drug are determined by the pharmacological effects of fat-soluble vitamins A and E, which are part of its composition. The drug affects the nuclei of cells of target organs and initiates the synthesis of protein enzymes or structural elements of tissues, stimulates regeneration processes, and increases the specific and nonspecific resistance of the body.
The drug normalizes metabolism, exhibits an active antioxidant effect, restores capillary blood circulation, tissue and vascular permeability, and increases tissue resistance to hypoxia.
Pharmacokinetics
AEvit is well absorbed from the digestive tract. Next, vitamins A and E are transported into the lymph, then into the blood plasma, where they bind to specific proteins and are transported to organs and tissues. Excess vitamin A is deposited in the liver, mainly in the form of palmitic acid esters. Vitamin A is excreted with bile into the intestines and participates in enterohepatic circulation. In the liver, it undergoes biotransformation, first turning into active metabolites, and then into inactive metabolic products excreted by the kidneys, intestines and lungs. Elimination of vitamin A occurs slowly - 34% of the dose of the drug is excreted from the body in 3 weeks. Excess vitamin E is deposited in the tissues, forming a depot in them (especially in the liver), which maintains a normal level of vitamin E in the blood plasma. In the body, vitamin E undergoes biotransformation, turning into a number of metabolites that have a quinone structure. Vitamin E in an unchanged state is excreted in the bile, and in the form of metabolites - in the urine.
Indication
AEvit is indicated for therapeutic use in diseases and conditions that require long-term administration of high doses of vitamin A in combination with vitamin E: atherosclerotic vascular changes, impaired tissue trophicity, obliterating endarteritis, psoriasis, systemic lupus erythematosus, optic nerve atrophy, retinitis pigmentosa, as part of the complex therapy of dermatitis and acne; in the complex therapy of cardiovascular diseases (hypertensive disease with signs of left ventricular overload, stable angina pectoris of functional classes I and II).
Contraindication
Hypersensitivity to the components of the drug, hypervitaminosis A and E, thyrotoxicosis, chronic glomerulonephritis, cholelithiasis, decompensated heart failure, history of sarcoidosis, chronic pancreatitis, severe cardiosclerosis, myocardial infarction.
Interaction with other medicinal products and other types of interactions
The drug should not be prescribed simultaneously with estrogens, which increase the risk of hypervitaminosis A; nitrites and cholestyramine, which impair the absorption of vitamin A.
Retinol palmitate reduces the anti-inflammatory effect of glucocorticoids.
The drug should not be used together with other vitamin A derivatives due to the risk of overdose and the development of hypervitaminosis A.
Vitamin E enhances the effect of steroidal and nonsteroidal anti-inflammatory drugs (diclofenac sodium, ibuprofen, prednisolone); reduces the toxic effect of cardiac glycosides (digitoxin, digoxin), vitamins A and D.
Application features
The drug should be used with caution in patients with an increased risk of thromboembolism, severe atherosclerosis of the coronary arteries, chronic circulatory failure, acute or chronic nephritis, cholecystitis, and severe lesions of the hepatobiliary system.
The drug should not be prescribed simultaneously with other drugs containing vitamin A and its synthetic analogues due to the risk of developing hypervitaminosis A.
Vitamin A has the property of accumulating and remaining in the body for a long time. Women who have taken high doses of retinol should not plan pregnancy earlier than in 6-12 months. This is due to the fact that during this time there is a risk of impaired fetal development under the influence of high vitamin A content in the body.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of the drug on the ability to drive a car or operate complex mechanisms.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy or breastfeeding.
If necessary, the appointment of the drug should be discontinued.
Method of administration and doses
Children
The medicine should not be used in children.
Overdose
A single dose of a large amount of the drug is accompanied by a sudden increase in cerebrospinal fluid pressure (without pathological changes in the cerebrospinal fluid itself), severe headache, drowsiness, visual impairment (diplopia). In severe cases, convulsions and heart failure develop. With prolonged use of the drug, chronic hypervitaminosis A may develop, which is manifested by nervous system lesions (headache, insomnia, irritability, apathy, paresthesias), general weakness, loss of appetite, fever, changes in the skin (dryness and cracks in the skin on the palms and soles, the appearance of pigment spots, hair loss, seborrheic rashes), jaundice, changes in the blood picture, pain in the bones and muscles, gait disorders, enlargement of the liver and spleen. When taking high doses for a long time, creatinuria, increased cholesterol and triglyceride concentrations, increased creatine kinase activity, decreased serum thyroxine and triiodothyronine concentrations, increased urinary estrogen and androgen content, decreased blood clotting, and gastrointestinal bleeding are possible. If signs of overdose appear, the drug should be discontinued.
Treatment is symptomatic.
Adverse reactions
From the nervous system and sensory organs: increased fatigue, drowsiness, lethargy, irritability, headache, loss of sleep.
Gastrointestinal: loss of appetite, nausea, dyspeptic disorders (epigastric pain, diarrhea); very rarely - vomiting.
Allergic reactions, including itching, rash; dry, flaky skin; fever; facial flushing.
Others: with prolonged use - hair loss, pain in the bones of the lower extremities.
With prolonged use, exacerbation of cholelithiasis and chronic pancreatitis is possible. Long-term use of large doses of vitamin A can cause the development of hypervitaminosis A.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
20 capsules in a blister; 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
