Instructions for Retinol acetate vitamin A oral oily solution 3.44% bottle 10 ml
Composition
active ingredient: retinol acetate (vitamin A acetate);
1 ml of the drug contains retinol acetate (vitamin A acetate) in terms of 100% retinol acetate – 34.4 mg (100,000 IU);
excipient: sunflower oil.
Dosage form
Oral oily solution.
Main physicochemical properties: transparent oily liquid from light yellow to dark yellow in color, without rancid odor and taste.
Pharmacotherapeutic group
Simple preparations of vitamin A. Retinol (vitamin A). ATX code A11C A01.
Pharmacological properties
Pharmacodynamics.
Vitamin A (retinol) belongs to the group of fat-soluble vitamins.
The drug Retinol acetate is an analogue of natural vitamin A and is necessary to restore the normal concentration of retinol in the body. Vitamin A plays an important role in the synthesis of proteins, lipids, mucopolysaccharides, and regulates the balance of minerals.
The most specific function of vitamin A is to ensure the processes of vision (photoreception). Retinol is involved in the synthesis of visual purple – rhodopsin, located in the rods of the retina.
Vitamin A modulates the processes of differentiation of epithelial cells, participates in the development of secretory glands, keratinization processes, and regeneration of mucous membranes and skin.
Vitamin A is necessary for the normal functioning of the endocrine glands and body growth, because it is a synergist of somatomedins.
Vitamin A affects the division of immunocompetent cells, the synthesis of factors of specific (immunoglobulin) and nonspecific (interferon, lysozyme) protection of the body against infectious and other diseases, and stimulates myelopoiesis.
Retinol increases the level of glycogen in the liver, stimulates the production of trypsin and lipase in the digestive system; inhibits photochemical free radical reactions and cysteine oxidation; activates the incorporation of sulfates into the components of connective tissue, cartilage, and bones; satisfies the need for sulfocerebrosides and myelin, ensuring the conduction and transmission of nerve impulses.
With a lack of vitamin A, twilight vision disorders (night blindness) and atrophy of the epithelium of the conjunctiva, cornea, and lacrimal glands develop. Degenerative-dystrophic processes are observed in the respiratory tract (mucous membranes of the nasopharynx, paranasal sinuses, trachea, and bronchi), in the genitourinary system (epithelium of the renal pelvis, ureters, bladder, urethra, vagina, ovaries, fallopian tubes, and endometrium, seminal vesicles and cords, and prostate gland), in the digestive system (mucous membrane of the digestive tract, salivary glands, and pancreas). Vitamin A deficiency leads to impaired skin trophism (hyperkeratosis), impaired growth and quality of hair and nails, and impaired function of the sebaceous and sweat glands. In addition, there is a decrease in body weight and a slowdown in bone growth, a decrease in the synthesis of glucocorticoids and steroid hormones, a violation of the body's resistance to infectious and other diseases. There is a tendency to cholelithiasis and nephrolithiasis.
A lack or excess of vitamin A in a woman's body can cause abnormalities in the intrauterine development of the fetus.
Retinol has an antitumor effect that does not extend to non-epithelial tumors.
Pharmacokinetics.
Retinol acetate taken orally is well absorbed in the upper parts of the small intestine. Then, as part of chylomicrons, it is transported from the intestinal wall into the lymphatic system and through the thoracic duct enters the bloodstream. Retinol esters are transported in the blood by β-lipoproteins. The maximum level of vitamin A esters in the blood serum is observed 3 hours after administration. The place of deposition of vitamin A is the liver parenchyma, where it accumulates in stable ester forms. In addition, a high content of vitamin A is determined in the pigment epithelium of the retina. This depot is necessary for the regular supply of vitamin A to the outer segments of rods and cones.
Retinol biotransformation occurs in the liver, then in the form of inactive metabolites it is excreted by the kidneys. Retinol can be partially excreted with bile and participate in enterohepatic circulation. Elimination of retinol occurs slowly - in 3 weeks 34% of the dose of the drug is excreted from the body.
Indication
A-vitaminosis and A-hypovitaminosis, eye diseases (retinitis pigmentosa, xerophthalmia, hemeralopia, superficial keratitis, corneal lesions, conjunctivitis, pyoderma and eczematous lesions of the eyelids), as part of complex therapy:
rickets;
acute respiratory diseases that occur against the background of exudative diathesis;
acute and chronic bronchopulmonary diseases;
hypotrophy;
collagenoses;
for pathological skin processes (frostbite, burns, wounds, ichthyosis, follicular dyskeratosis, senile keratosis, skin tuberculosis, some forms of eczema, psoriasis), for inflammatory and ulcerative-erosive lesions of the intestines, and cirrhosis of the liver.
Contraindication
Hypersensitivity to the components of the drug, acute and chronic nephritis, heart failure in the decompensation stage, cholelithiasis, chronic pancreatitis, hypervitaminosis A, retinoid overdose, hyperlipidemia, obesity, chronic alcoholism, sarcoidosis (including a history).
Interaction with other medicinal products and other types of interactions
Estrogens increase the risk of developing hypervitaminosis A.
Retinol acetate reduces the anti-inflammatory effect of glucocorticoids.
Retinol acetate should not be taken simultaneously with nitrites and cholestyramine, as they impair the absorption of the drug.
Retinol acetate should not be used together with other vitamin A derivatives due to the risk of overdose and development of hypervitaminosis A.
The combination with vitamin E helps preserve retinol acetate in its active form, absorb it from the intestines, and produce anabolic effects.
Simultaneous use of vaseline oil may disrupt the absorption of the vitamin in the intestines.
Concomitant use of vitamin A and anticoagulants increases the tendency to bleed.
Application features
The drug should be taken under the supervision of a doctor. With prolonged use of Retinol acetate, it is necessary to monitor biochemical parameters and blood clotting time.
When treating night vision disorders (night blindness), Retinol acetate should be used in complex treatment.
Use with caution in severe damage to the hepatobiliary system, diseases accompanied by blood clotting disorders.
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.
The drug has the property of accumulating and remaining in the body for a long time. Women who have taken high doses of retinol can plan pregnancy no earlier than 6-12 months later. This is due to the fact that during this time there is a risk of abnormal development of the fetus under the influence of high levels of vitamin A in the body.
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 large dose of vitamin A in this dosage form, the drug is contraindicated for oral administration during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
There is no data on the effect of the drug on the ability to drive a car or operate complex mechanisms.
Method of administration and doses
Retinol acetate should be administered orally 10-15 minutes after meals and externally.
1 ml of the drug contains 100,000 IU (25 drops) of vitamin A.
1 drop from the dropper bottle contains about 4,000 IU of vitamin A.
When determining drug doses, assume that the highest single dose of vitamin A is:
for adults – 50,000 IU (12 drops of the drug (48,000 IU);
for children from 7 years old - up to 5000 IU (1 drop of the drug (4000 IU).
The highest daily dose of vitamin A is:
for adults – 100,000 IU (25 drops of the drug);
for children over 7 years old – 20,000 IU (5 drops of the drug).
Therapeutic doses of vitamin A for mild and moderate avitaminosis are up to 33,000 IU (8 drops of the drug (32,000 IU) per day) for adults.
For skin diseases, as well as for retinitis pigmentosa, xerophthalmia, and hemeralopia, the daily dose of vitamin A is 50,000-100,000 IU (12-25 drops of the drug (48,000-100,000 IU).
For the treatment of children aged 7 years and older, prescribe 3000-6000 IU (1 drop of the drug (4000 IU) per day, depending on the nature and course of the disease.
In case of skin surface lesions (ulcers, burns, frostbite), after hygienic cleaning, lubricate the affected areas with the solution and cover with a gauze bandage (5-6 times a day, with a decrease in the number of applications to one depending on epithelialization).
Children
The drug is prescribed to children aged 7 years and older.
Overdose
Symptoms of overdose: dizziness; confusion, diarrhea, severe dehydration, irritability; generalized rash with subsequent large-scale peeling, starting from the face; bleeding gums, dryness and ulceration of the oral mucosa, peeling of the lips, sharply painful palpation of long tubular bones due to subperiosteal hemorrhages.
Acute and chronic hypervitaminosis A is accompanied by severe headache, fever, drowsiness, vomiting, visual impairment (double vision), dry skin, pain in joints and muscles, the appearance of age spots, an increase in the size of the liver and spleen, jaundice, changes in the blood picture, loss of strength and appetite. In severe cases, convulsions, heart failure and hydrocephalus develop.
Treatment: Treatment is symptomatic.
Side effects
Prolonged intake of large doses of vitamin A can cause the development of hypervitaminosis A.
From the nervous system and sensory organs: rapid fatigue, drowsiness, lethargy, irritability, headache, sleep loss, convulsions, discomfort, intraocular hypertension, visual impairment.
On the part of the digestive tract: loss of appetite, weight loss, nausea, very rarely - vomiting.
Exacerbation of liver diseases, increased activity of transaminases and alkaline phosphatase are possible.
From the urinary system: pollakiuria, nocturia, polyuria.
From the hematopoietic system: hemolytic anemia.
Allergic reactions: cracks in the skin of the lips, yellow-orange spots on the soles of the feet, palms, in the nasolabial triangle area, subcutaneous edema; in some cases, itchy maculopapular rashes may occur on the first day of use, requiring discontinuation of the drug; itching, erythema and rash, dry skin, dry mouth, fever, facial hyperemia with subsequent peeling.
Others: hair loss, menstrual irregularities, abdominal pain, aphthae, photosensitivity, hypercalcemia.
With a decrease in the dose or with temporary discontinuation 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.
Expiration date
2 years.
Storage conditions
Store in the original packaging in the refrigerator (at a temperature of + 2 ºС to + 8 ºС).
Keep out of reach of children.
Packaging
10 ml in glass vials or polymer vials, closed with dropper stoppers. 1 vial in a cardboard pack.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Address
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
