Vitamin a-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAMIN A-ZDOROVYE (VITAMIN A-ZDOROVYE)

Composition:

Active substance: retinol (vit A);

for dose 33000 IU

1 soft capsule contains vitamin A 33000 IU;

Excipients: sunflower oil;

capsule shell containing: gelatin, glycerin, methylparaben (E 218), propylparaben (E 216), azorubine (E 122);

for dose 100000 IU

1 soft capsule contains vitamin A 100000 IU;

Excipients: sunflower oil;

capsule shell containing: gelatin, glycerin, methylparaben (E 218), propylparaben (E 216).

Pharmaceutical form. Soft capsules.

Main physicochemical properties:

Soft capsules 33000 IU – soft gelatin capsules of spherical or nearly spherical shape with a seam, red in color, filled with oily liquid ranging from light yellow to dark yellow;

Soft capsules 100000 IU – soft gelatin capsules of spherical or nearly spherical shape with a seam, from light yellow to dark yellow in color, filled with oily liquid ranging from light yellow to dark yellow.

Pharmacotherapeutic group. Simple vitamin A preparations. Retinol (vitamin A).
ATC code A11CA01.

Pharmacological properties.

Pharmacodynamics.

Vitamin A exerts a general tonic effect and normalizes tissue metabolism: it participates in redox processes (due to a large number of unsaturated bonds), in the synthesis of mucopolysaccharides, proteins, lipids, in mineral metabolism, and in cholesterol formation. It enhances the production of lipase and trypsin, stimulates myelopoiesis and cellular division processes. It promotes the proliferation of skin epithelial cells, rejuvenates the cell population, reduces the number of cells undergoing terminal differentiation, inhibits keratinization processes, enhances glycosaminoglycan synthesis, activates interactions between immunocompetent cells and epidermal cells, and stimulates skin regeneration. Retinol is essential for the normal functioning of the retina: it binds with opsin (the red pigment of the retina) to form rhodopsin (visual purple), which is necessary for visual adaptation in darkness.

The local effect is mediated by the presence of specific retinol-binding receptors on the surface of epithelial cells.

Pharmacokinetics.

Vitamin A is almost completely absorbed in the intestine (mainly in the duodenum and rectum). Maximum plasma concentration of the drug is reached within 4 hours after administration. Retinol is unevenly distributed throughout the body. The highest concentrations are found in the liver and adipose tissue; it is also present in the kidneys, fat depots, adrenal glands, and other endocrine glands. Retinol metabolites are excreted by the kidneys. The half-life elimination period is 9.1 hours. Retinol is not detectable in the urine of healthy individuals, as it is excreted via bile.

Clinical Characteristics.

Indications.

Vitamin A deficiency.

Eye diseases: pigmentary retinitis, xerophthalmia, hemeralopia, eczematous lesions of the eyelids, superficial keratitis, corneal lesions, conjunctivitis, pyoderma.

Skin diseases and skin lesions: frostbite, burns, wounds, ichthyosis, follicular keratosis, hyperkeratosis, cutaneous tuberculosis, psoriasis, certain forms of eczema.

As part of complex therapy for acute respiratory diseases occurring against the background of exudative diathesis, chronic bronchopulmonary diseases; inflammatory, erosive-ulcerative intestinal lesions, liver cirrhosis, rickets, collagenoses, hypotrophies.

Contraindications.

Hypersensitivity to the components of the drug, acute and chronic nephritis, cardiac insufficiency grade II–III, cholelithiasis, chronic pancreatitis, hypervitaminosis A, retinoid overdose, hyperlipidemia, obesity, chronic alcoholism, sarcoidosis (including in the medical history).

Interaction with other medicinal products and other types of interactions.

Estrogens and oral contraceptives containing them enhance the absorption of retinol, which may lead to the development of hypervitaminosis A. Cholestyramine, colestipol, mineral oils, neomycin reduce the absorption of vitamin A (an increased dose may be required). Nitrates impair retinol absorption.

Prolonged therapy with tetracyclines should not be combined with high-dose vitamin A (50,000 IU and higher) due to increased risk of developing intracranial hypertension. Retinol reduces the effect of Ca2+ preparations and increases the risk of hypercalcemia. Isotretinoin increases the risk of toxic effects.

Vitamin E reduces the toxicity, absorption, and hepatic storage of vitamin A; high doses of vitamin E may reduce vitamin A stores in the body. Retinol reduces (mutually) the risk of hypervitaminosis D. Corticosteroids and alcohol consumption reduce the therapeutic effect of the drug. Concurrent use of vitamin A and anticoagulants increases the tendency to bleeding. Retinol reduces the anti-inflammatory effect of glucocorticoids.

Special precautions for use.

The drug has the property of accumulating and remaining in the body for a prolonged period; therefore, it should not be taken simultaneously with other medicinal products containing vitamin A. Prolonged daily use of the drug, especially in high doses, may lead to the development of hypervitaminosis A due to accumulation in the body.

Use with caution in diseases associated with impaired blood coagulation or tendency to bleeding, calcium loss from the body, severe liver damage, and acute or chronic hepatitis. To monitor liver function, biochemical blood tests should be performed before the start of treatment and during therapy.

The drug is not recommended during prolonged therapy with tetracyclines.

Retinol should be taken 1 hour before or 4–6 hours after cholestyramine administration.

The presence of fats in food is essential for normal absorption of vitamin A.

Alcohol abuse and smoking impair absorption of the drug from the gastrointestinal tract.

When treating impaired twilight vision (night blindness), vitamin A should be administered together with riboflavin and nicotinic acid.

Women who have taken high doses of retinol palmitate (more than 10,000 IU) should not plan pregnancy earlier than 6–12 months after discontinuation. This is due to the risk of fetal developmental abnormalities caused by high levels of vitamin A in the body during this period.

The drug contains methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed).

The drug in the dose of 33,000 IU contains azorubine (E 122), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Due to the high dose of vitamin A, this medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

No data available.

Dosage and Administration

The medication should be taken orally 10–15 minutes after a meal.

Due to vitamin A's potential for accumulation in the body, caution should be exercised regarding the dose of retinol palmitate (especially capsules containing 100,000 IU).

The daily dose for adults should not exceed 100,000 IU.

For therapeutic purposes in cases of mild to moderate vitamin A deficiency, adults are prescribed up to 33,000 IU per day; in eye disorders – 33,000–100,000 IU per day; in skin diseases – 33,000–100,000 IU per day.

The dosage and duration of vitamin A treatment are determined individually by a physician.

Children. The medication is contraindicated in children.

Overdose.

Symptoms: severe headache, dizziness; drowsiness, confusion, visual disturbances, seizures, persistent vomiting, profuse diarrhea, severe dehydration, irritability; on the second day, widespread rash appears followed by extensive desquamation, starting from the face; gingival bleeding, dryness and ulceration of the oral mucosa, chapped lips, painful palpation of long tubular bones due to subperiosteal hemorrhages, joint and muscle pain.

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

Adverse reactions.

Gastrointestinal system: loss of appetite, dryness of the oral mucosa, stomach pain, vomiting, nausea.

Hepatobiliary system: hepatotoxic effects, portal hypertension.

Skin and subcutaneous tissue: skin and lip fissures and dryness, yellow-orange spots on the palms, soles, and in the nasolabial triangle area, subcutaneous edema; in individual cases, during the first day of use, pruritic maculopapular rashes may occur, requiring discontinuation of the drug.

Nervous system: asthenia, excessive fatigue, drowsiness, discomfort, headache, irritability, increased intraocular pressure, visual disturbances, gait disturbances.

Endocrine system: oligomenorrhea.

Urinary system: pollakiuria, nocturia, polyuria.

Blood system: hemolytic anemia.

Musculoskeletal system: bone pain, changes on bone X-rays, cramps.

Other: hyperthermia, hair loss, photosensitivity, weight loss, hypercalcemia; hypersensitivity reactions are possible.

Adverse effects resolve spontaneously upon dose reduction or temporary discontinuation of the drug.

In skin disorders, administration of high drug doses may be accompanied, after 7–10 days of treatment, by exacerbation of local inflammatory response, which does not require additional therapy and diminishes over time. This effect is associated with the myelo- and immunostimulatory action of the drug.

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging.

Soft capsules, 50 pcs (10×5) in blisters, in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and location of business activities.

100, Shevchenka St., lit. B-II (Building 4), Boryspil, Kyiv region, 08301, Ukraine.

Website: www.zt.com.ua.