FENTAVERA

INSTRUCTIONS for medical use of the drug VITAMIN A (VITAMIN A)

Composition

active substance: retinol; for a dose of 33000 IU, 1 capsule contains 33000 IU of vitamin A; excipients: sunflower oil; capsule shell: gelatin, glycerin, carmoisin (E 122); for a dose of 100000 IU, 1 capsule contains 100000 IU of vitamin A; excipients: sunflower oil; capsule shell: gelatin, glycerin.

Pharmaceutical form

Soft capsules.

Main physical and chemical properties

for a dose of 33000 IU - soft gelatin capsules of spherical or spherical shape, with a seam, red in color, filled with an oily liquid from light yellow to dark yellow; for a dose of 100000 IU - soft gelatin capsules of spherical or spherical shape, with a seam, from light yellow to dark yellow, filled with an oily liquid from light yellow to dark yellow.

Pharmacotherapeutic group

Simple vitamin A preparations. Retinol (vitamin A). ATC code A11C A01.

Pharmacological properties

Pharmacodynamics

Vitamin A has a general strengthening effect, normalizes tissue metabolism: it participates in oxidation-reduction processes (through a large number of unsaturated bonds), in the synthesis of mucopolysaccharides, proteins, lipids, in mineral metabolism, in the processes of cholesterol formation. It enhances the production of lipase and trypsin, enhances myelopoiesis, cell division processes. It has a positive effect on the function of lacrimal, sebaceous, and sweat glands; increases resistance to diseases of the mucous membranes of the respiratory tract and intestines; increases the body's resistance to infections. It enhances the proliferation of skin epithelial cells, rejuvenates the cell population, and reduces the number of cells undergoing terminal differentiation, inhibits keratinization processes, enhances the synthesis of glycosaminoglycans, activates the interaction of immunocompetent cells with each other and with epidermal cells. Stimulates skin regeneration. Retinol is a necessary component for the normal functioning of the retina: it binds to opsin (the red pigment of the retina), forming visual purple - rhodopsin, necessary for visual adaptation in the dark.

Pharmacokinetics

Vitamin A is almost completely absorbed in the intestine (mainly in the duodenum and rectum). After administration, the maximum concentration of the drug in the blood plasma is observed after 4 hours. Retinol is distributed unevenly throughout the body. The largest amount of it is found in the liver and kidneys, it is detected in fat deposits, adrenal glands, and other endocrine glands. The metabolites of retinol are excreted by the kidneys. The half-life is 9.1 hours. In the urine of a healthy person, retinol is not determined, since it is excreted as part of bile.

Clinical characteristics

Indications

A-avitaminosis and A-hypovitaminosis. Eye diseases: pigmentary retinitis, xerophthalmia, hemeralopia, eczematous lesions of the eyelids, superficial keratitis, corneal lesions, conjunctivitis, pyoderma. Skin diseases: frostbite, burns, wounds, ichthyosis, follicular dyskeratosis, senile keratosis, skin tuberculosis, psoriasis, some forms of eczema. Complex therapy for rickets, collagenosis, hypotrophy. As part of complex therapy for acute respiratory diseases that occur against the background of exudative diathesis, chronic bronchopulmonary diseases; inflammatory, erosive-ulcerative lesions of the intestine, liver cirrhosis.

Contraindications

Hypersensitivity to the components of the drug, acute and chronic nephritis, heart failure II-III degree, cholelithiasis, chronic pancreatitis, hypervitaminosis A, retinoid overdose, hyperlipidemia, obesity, chronic alcoholism, sarcoidosis (including in history).

Interaction with other drugs and other types of interactions

Estrogens and oral contraceptives containing them enhance the absorption of retinol, which can lead to the development of hypervitaminosis A. Cholestyramine, colestipol, mineral oils, neomycin reduce the absorption of vitamin A (may require an increase in its dose). Nitrates disrupt the absorption of retinol.

During long-term therapy with tetracyclines, it is not recommended to prescribe vitamin A in high doses (50000 IU and above) due to the increased risk of developing intracranial hypertension. Retinol weakens the effect of Ca2+ preparations, increases the risk of developing hypercalcemia. Isotretinoin increases the risk of a toxic effect.

Vitamin E reduces the toxicity, absorption, and deposition in the liver of vitamin A; high doses of vitamin E can reduce the reserves of vitamin A in the body. Retinol reduces (mutually) the risk of hypervitaminosis D. Corticosteroids and alcohol consumption reduce the therapeutic effect of the drug. Simultaneous administration of vitamin A and anticoagulants increases the tendency to bleeding. Retinol reduces the anti-inflammatory effect of glucocorticoids.

Features of application

The drug has the ability to accumulate and stay in the body for a long time, so it is not recommended to take the drug simultaneously with other drugs that contain vitamin A.

Long-term daily use of the drug, especially in large doses, can cause the development of hypervitaminosis A.

It should be used with caution in diseases accompanied by impaired blood coagulation or the development of bleeding, loss of calcium by the body, in severe liver damage, acute and chronic hepatitis. To control liver function before and during treatment, a biochemical blood test should be performed.

It is not recommended to use the drug during long-term therapy with tetracyclines.

Retinol should be taken 1 hour before or 4-6 hours after taking cholestyramine.

For normal absorption of vitamin A, the presence of fats in food is a necessary condition.

Alcohol and tobacco abuse disrupts the absorption of the drug from the digestive tract.

Use during pregnancy or breastfeeding

Given the high dose of vitamin A, this drug is contraindicated during pregnancy or breastfeeding.

Ability to affect the speed of reaction when driving vehicles or other mechanisms

There is no data that retinol can affect the speed of psychomotor reactions when driving a vehicle or working with precise mechanisms.

Method of application and doses

Retinol is used for therapeutic purposes in adults with avitaminosis of moderate and mild severity. The drug should be taken orally 10-15 minutes after eating.

Given the ability of vitamin A to accumulate in the body, before taking the drug, attention should be paid to the dose of retinol palmitate (especially when using capsules of 100000 IU).

The daily dose for adults should not exceed 100000 IU.

For therapeutic purposes, in case of avitaminosis of mild and moderate severity, adults are prescribed 33000 IU per day, in case of eye diseases - 33000-100000 IU per day. In case of skin diseases, adults are prescribed 33000-100000 IU per day.

The doses and duration of treatment with Vitamin A are determined by the doctor individually.

Children

The drug is contraindicated in children.

Overdose

Symptoms: severe headache, dizziness; drowsiness, confusion, visual disturbances, convulsions, uncontrollable vomiting, profuse diarrhea, severe dehydration of the body, irritability; on the second day, a widespread rash appears with subsequent large-scale peeling, starting from the face; bleeding gums, dryness and ulceration of the oral mucosa, peeling of the lips, palpation of long tubular bones is sharply painful due to subperiosteal hemorrhages, pain in the joints and muscles.

Treatment: symptomatic; as an antidote, thyroxine and ascorbic acid are prescribed.

Side effects

From the digestive system: loss of appetite, dryness of the oral mucosa, abdominal pain, vomiting, nausea.

From the liver and biliary system: hepatotoxic phenomena, portal hypertension.

From the skin and subcutaneous tissue: cracks and dryness of the skin, lips, yellow-orange spots on the soles, palms, in the area of the nasolabial triangle, subcutaneous edema, in some cases, on the first day of application, itching, patchy-papular rashes may occur, which requires cancellation of the drug.

From the nervous system: asthenia, excessive fatigue, drowsiness, discomfort, headache, irritability, intraocular hypertension, visual disturbances, gait disturbances.

From the endocrine system: oligomenorrhea.

From the urinary system: polyuria, nocturia, polyuria.

From the blood system: hemolytic anemia.

From the musculoskeletal system: bone pain, changes on X-rays of bones, convulsions.

Others: hyperthermia, hair loss, photosensitivity, weight loss, hypercalcemia; when using the drug, allergic reactions are possible.

With a decrease in dose or temporary cancellation of the drug, side effects disappear on their own.

In skin diseases, the use of high doses of the drug after 7-10 days of treatment may be accompanied by an exacerbation of the local inflammatory reaction, which does not require additional treatment and subsequently decreases. This effect is associated with the myelo- and immunostimulating effect of the drug.

Shelf life

2 years.

Storage conditions

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

Store in a place inaccessible to children.

Packaging

For a dose of 33000 IU.

10 capsules in a blister pack; 3 blister packs in a pack.

10 capsules in a blister pack; 5 blister packs in a pack.

20 capsules in a blister pack; 1 blister pack in a pack.

20 capsules in a blister pack; 3 blister packs in a pack.

For a dose of 100000 IU.

10 capsules in a blister pack; 3 blister packs in a pack.

10 capsules in a blister pack; 5 blister packs in a pack.

20 capsules in a blister pack; 1 blister pack in a pack.

20 capsules in a blister pack; 3 blister packs in a pack.

Release category

Without a prescription.

Manufacturer

Kyiv Vitamin Plant, JSC.

Location of the manufacturer and address of the place of its activity

Ukraine, 04073, Kyiv, Kopilovskaya street, 38.

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