Retinol acetate (Retinol acetate)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceRetinolRetinol
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    • Dosage form: & nbspDrops for oral and external use.
    Composition:

    Active substance:

    Retinol acetate - 34,4 g or 86,0 in

    Auxiliary substances: butylhydroxyanisole - 0,5 g or 1,25 g, sunflower oil (sunflower oil refined deodorized) to 1 l.

    The composition of the substance retinol acetate is butylhydroxytoluene and peanut oil. In the preparation, butylhydroxytoluene is present in an amount of 1,0 g and 2,5 g in solutions of concentration 3,44 % and 8,6 % respectively.

    Table of Contents C22H32ABOUT2 (retinol acetate) in 1 ml 3,44 % and 8,6 % preparation should be 100000 ME and 250000 ME respectively.

    Description:Transparent oily liquid from light yellow to dark yellow without rancid smell.

    Pharmacotherapeutic group:Vitamin.
    ATX: & nbsp

    A.11.C.A   Vitamin A

    A.11.C.A.01   Retinol

    Pharmacodynamics:

    Retinol is a necessary component for the normal function of the retina of the eye: it binds to opsin, forming a visual purple rhodopsin, necessary for twilight vision. Retinol (vitamin A) is involved in the regulation of epithelial division and differentiation (enhances epithelial differentiation, stimulates secretory cell formation, inhibits keratinization); is necessary for the growth of bones, normal reproductive function, embryonic development.

    Pharmacokinetics:

    Quickly absorbed from the digestive tract (mainly from the 12-finger and jejunum), the presence of bile acids, pancreatic lipase, proteins and fats is required.The connection with plasma proteins (lipoproteins) is normal - less than 5 %; In case of an overdose of retinol (vitamin A) with food and overflow to the liver depot, its association with plasma lipoproteins can reach up to 65 %. The amount of bound retinol (vitamin A) with lipoproteins can increase with hyperlipoproteinemia. When released from the liver depot retinol (vitamin A) forms a complex with a retinol-binding protein, in the form of which circulates in the blood. In small amounts penetrates into breast milk and through the placenta.

    It is deposited in the liver (approximately in the amount of the biennial needs of the adult organism), in small amounts - in the kidneys, lungs. To mobilize retinol (vitamin A) from the depot zinc-containing substances are required.

    Metabolised in the liver. It is excreted with feces (non-sucking part) and kidneys.

    Indications:

    Hypovitaminosis, avitaminosis A. In complex therapy with concomitant vitamin A deficiency:

    - eye diseases (retinitis pigmentosa, hemostalopia, xerophthalmia, keratomalacia, eczematous lesions of the eyelids).

    - diseases and skin lesions (frostbite, burns, wounds, erosion, ulcers, cracks, ichthyosis, hyperkeratosis, psoriasis, atopic dermatitis, neurodermatitis,tylotic (horny, corn-like) eczema, eczema in the subacute and acute stage).

    Contraindications:

    Hypersensitivity, hypervitaminosis A, pregnancy, cholelithiasis, chronic pancreatitis, acute inflammatory skin diseases, children under seven.

    Carefully:

    Alcoholism, cirrhosis of the liver, viral hepatitis, renal failure, elderly age. If you have any of the listed diseases or conditions, always consult a doctor before taking the drug.

    Pregnancy and lactation:

    Currently, there is no information on the adverse effects of taking the drug during lactation in the recommended daily doses.Retinol (vitamin A) penetrates into breast milk in a small amount).

    Dosing and Administration:

    The drug should be used under medical supervision.

    The drug is taken orally (through 10-15 minutes after eating).

    With avitaminosis of mild and moderate degree to adults - 33000 ME (11,35 mg) (3,44 % preparation - 0,33 ml, from the eye dropper - 13 drops, from the cap-dropper - 10 drops; 8,6 % - 0,13 ml, from the eye dropper - 5 drops, from the cap-dropper - 4 drops) per day; with eye disease - 50000-100000 ME (17,20-34,40 mg) (3,44 % - 0,50-1,00 ml, from the eye dropper - 20-40 drops, from the cap-dropper - 14-28 drops; 8,6 % - 0,20-0,40 ml, from the eye dropper - 8-16 drops, from the cap-dropper - 6-8 drops) per day; children - 1000-5000 ME (0,34-1,72 mg) (3,44 % - 0,01-0,05 ml, from the eye dropper - 1-2 drops, from the cap-dropper - 1 a drop; 8,6 % - 0,004-0,02 ml, from the eye dropper - 1 drop, from the cap-dropper - 1 drop) per day, depending on the age; with adult skin diseases - 50000-100000 ME (17,20-34,40 mg) (3,44 % - 0,50-1,00 ml, from the eye dropper - 20-40 drops, from the cap-dropper - 14-28 drops; 8,6 % - 0,20-0,40 ml from the eye dropper - 8-16 drops, from the cap-dropper - 6-8 drops) per day; children 5000-20000 ME (1,72-6,88 mg) (3,44 % - 0,05-0,20 ml from the eye dropper - 2-8 drops, from the cap-dropper - 2-6 drops; 8,6 % - 0,02-0,08 ml, from the eye dropper - 1-4 drops, from the cap-dropper - 1-2 drops) per day.

    With burns, ulcers and frostbite at the same time as the preparation is administered, the local treatment of the affected skin with an oil solution of retinol (vitamin A) is performed. On the previously cleaned affected area of ​​the skin, apply the drug and cover with gauze (up to 5-6 once a day, as scarring and epithelization, the lubrication frequency is reduced to 1 times a day).

    One Drop 3,44 % and 8,6 % of the preparation from the eye dropper (0,025 ml) contains about 2500 ME (0,86 mg) and 6250 ME (2,15 mg), respectively.

    One Drop 3,44 % and 8,6 % of the drug from the cap-dropper (0,035 ml) contains about 3500 ME (1,20 mg) and 8750 ME (3,01 mg), respectively.

    The duration of treatment is determined by the doctor.


    Side effects:

    Allergic reactions. If the side effect specified in the instructions is aggravated, or you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Symptoms of acute, overdose (develop through 6 h after administration): hypervitaminosis A: the adults - drowsiness, lethargy, double vision, dizziness, severe headache, nausea, severe vomiting, diarrhea, irritability, osteoporosis, bleeding gums, dryness and ulceration of the oral mucosa, exfoliation of the lips, skin (especially the palms), confusion, increased intracranial pressure (in infants - hydrocephalus, protrusion of the fontanel).

    Symptoms of chronic intoxication: intoxication, hypervitaminosis A, loss of appetite, bone pain, cracks and dry skin, lips, dry mucous membrane of the oral cavity, gastralgia, vomiting, hyperthermia, asthenia, excessive fatigue, discomfort, headache, photosensitivity, pollakiuria, nocturia, polyuria, irritability , hair loss,yellow-orange spots on the plantar surfaces of the feet, the palms, in nasolabial triangle hepatotoxic effects, ocular hypertension, oligomenorrhea, portal hypertension, haemolytic anemia, changes on radiographs bones, cramps.
    Treatment: discontinuation of the drug; symptomatic therapy.

    Interaction:

    During prolonged therapy with tetracyclines it is not recommended to prescribe retinol (vitamin A) (increased risk of developing intracranial hypertension).

    Vitamin E reduces toxicity, absorption, deposition in the liver of retinol; high doses of vitamin E can reduce the reserves of retinol in the body. Absorption of retinol breaks nitrite, colestramine.

    Special instructions:

    Do not use at the same time other multivitamin complexes containing vitamin A, in order to avoid an overdose.

    The daily requirement for retinol (vitamin A) is for adults 0,9 mg; for children - from 0,4 before 1 mg.

    In the Far North, doses for lactating women and children are increased by 50 %.

    Effect on the ability to drive transp. cf. and fur:

    Data on the adverse effects of retinol acetate in recommended doses on the ability to drive or work withno mechanisms.

    Form release / dosage:

    Solution for oral and external use oily 3,44 % and 8,6 %.

    Packaging:

    By 10, 15, 30, 50 ml in bottles of dark glass, sealed with polyethylene plugs and caps screwed or plastic caps with gaskets; or 10 ml in bottles of brown glass, ukuporennye lids-droppers; or 10, 30, 50 ml in bottles of brown glass, ukuporennye screw caps with droppers and without. Each bottle, together with the instructions for use, is placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of not more than 10 FROM.

    Keep out of the reach of children.

    Shelf life:

    3 of the year.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001035
    Date of registration:21.10.2011
    The owner of the registration certificate:PHARMACEUTICAL FACTORY of St. Petersburg, JSC PHARMACEUTICAL FACTORY of St. Petersburg, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspPHARMACEUTICAL FACTORY of St. Petersburg JSC PHARMACEUTICAL FACTORY of St. Petersburg JSC Russia
    Information update date: & nbsp05.08.2015
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