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International generic name
Retinol
Drug form and composition
Solution, oral drops. 5 milliliters of oil solvent contains 40 000 UI Retinol
palmitate (8 000 UI/ml).
Indications
For prevention and treatment of hypovitaminosis A. The preparation is used for
treatment of the following diseases: nyctalopia, photophobia; xerophthalmia; folicular
keratosis; keratomalacia; injuries; diskeratois; ichthyosis; diffuse and local hyperkeratosis;
seborrheic eczema; akne; skin burnings and freeze damages with retarded epithelization;
stomatitis; gingivitis; gastritis; ulcers of the stomach and duodenum; diarrhea;
gastrectomy; intestinal diseases; malabsorbtion syndrome in pancreatic insufficiency;
protein deficiency; hyperthyroidism; measles and long-term stress.
Dosage and administration
Vitamin A is applied orally, 15 000 UI (4.5 mg) daily; in severe deficiency higher
dose is used – up to 50 000 UI daily. In hyperthyroidism and skin diseases – 100
000-200 000 UI daily within 6 weeks, after which the dose is reduced to 50 000 UI
daily. In newborns and breast-feed children the dose should not exceed 1000-1500
UI/kg daily.
Contraindications
Hypersensitivity to vitamin A, chronic alcohol abuse; liver diseases; chronic
renal failure and malignant neoplasm.
Special warnings and precautions
High doses of vitamin A was not approved to be effective in aging and damaged
skin (for example acne). In this reason its application in such cases is not advisable.
During the pregnancy and nursing the preparation should be used with care after
careful consideration of the individual dosage and duration of the treatment. Data
exist that a daily dose higher than 6 000 UI may exert a harmful influence on the
fetus. The treatment with therapeutic dose vitamin A during lactation has no harmful
effect on the baby.
Drug interactions
Alcohol and retinoid compounds increase toxicity of vitamin A. The oral contraceptives
elevate the vitamin A serum level, whereas nitrites and cholestiramin reduce its
resorption. Combined treatment with vitamin A and vitamin E has shown a very good
effectiveness in the treatment of the gynecology, dermatology and geriatric diseases.
In the treatment of day-blindness the combination with riboflavin and nicotinic
acid is suitable.
Adverse reactions
Following adverse reaction may appear: somnolence, headache, intracranial pressure
elevation, rhagades, hyperpyrexia. With plasma vitamin A level about 50 000 UI per
100 ml vomiting, itching, visual nerve pupil swelling, diplopia, and skin hyperplasia
could be seen.
Pharmacological mechanisms
Retinol (Vitamin A) participates in the protein metabolism of the skin and mucous
membranes, as well as in synthesis of the visual pigment rhodopsin. It participates
also in mucopolysaccharide matabolism. In case of retinol deficiency the equilibrium
between metionine and cysteine in epithel cells is disturbed, which leads to increased
destruction and tendency to keratosis of the latter. Vitamin A defficiency inhibits
the glycogen synthesis from glycerin, lactate and acetate, as well as transformation
of triose to glucose. Vitamin A stimulates synthesis of suprarenal hormones. Probably
the retinol growth hormone effect is related to its stimulating action on the sexual
hormone and corticosteroid synthesis. Moreover it potentiates the formation of the
skeleton, increases organism resistance to cold and to infection diseases. Vitamin
A possesses exceptionally beneficial influence on the regeneratory process of the
skin and mucous membranes.
Supplied
One flacon with solution of 5 ml and dropper.
Expiry
1 year
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