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Composition of the drug


active ingredient: adapalene;


1 g contains adapalene 1 mg;


excipients: dinarium edetate carbomer 940 propylene glycol methyl parahydroxybenzoate (E 218) poloxamer 407 phenoxyethanol sodium hydroxide purified water.


Dosage form


Gel.


White color uniform opaque gel.


Pharmacotherapeutic group


Drugs for the treatment of acne. Retinoids for topical acne treatment.


PBX code D10A D03.


Adapalene is a derivative of naphthoic acid a retinoid like substance that modulates the processes of cellular differentiation and keratinization as well as inflammatory processes in the skin which are the main pathogenetic links in the development of acne. Adapalene binds to the retinoid receptors of the cell nucleus and thus promotes normal differentiation of epithelial cells of follicles which leads to a decrease in the formation of microcomedones and prevents the development of acne helps to maintain intact skin.


The therapeutic effect of the drug is usually detected within 8-12 weeks from the start of treatment. When using adapalene as a gel, the degree of absorption of the drug through the skin into the blood is extremely low.


Indications for use


Topical treatment of common acne (acne vulgaris).


Contraindications


Hypersensitivity to adapalene or other components of the drug.


Proper safety measures when applying


The drug is intended for topical use only. Avoid contact of the gel with the eyes lips areas of the wings of the nose and with the skin around the eyes as well as with the mucous membranes. If the gel gets on these areas, they should be thoroughly rinsed with warm water. Do not apply the gel to areas with eczematous skin lesions, sunburn, cuts, or other skin lesions. During treatment, excessive exposure to sunlight and ultraviolet light, including lamps, should be avoided due to increased skin vulnerability and an increased risk of solar erythema.


The use of cosmetics that dry the skin during treatment with the drug (such as abrasive or therapeutic soaps skin cleaners products containing excessive amounts of alcohol astringents creams or lotions for or after shaving products detergents) can cause an irritating effect.


If an allergy occurs during treatment with the drug, therapy should be discontinued and a doctor should be consulted.


Use during pregnancy or lactation


Do not use during pregnancy, as adequate clinical trials regarding the safety of adapalene use in pregnant women have not been conducted. It is not known whether adapalene is secreted in breast milk, so the use of the drug during breast-feeding is not recommended.


Ability to influence the reaction rate when driving vehicles or working with other mechanisms.


Since the absorption of the drug through the skin is almost nonexistent, the effect of the active substance on the reaction rate is unlikely.


Children


The safety and efficacy of the drug in children under 12 years of age have not been studied, so the drug should not be used in children under 12 years of age.


Dosage and administration


Deriva water gel is used for topical treatment of acne in adults and children over 12 years of age. The gel should be applied in a thin layer on clean, dry skin in places of rashes 1 time a day at night.


During the first weeks of treatment, the acne process may worsen due to exposure to


active substance on the lesions previously invisible. In this case, treatment should not be discontinued, the therapeutic effect is observed 8-12 weeks after the start of treatment. There may also be a feeling of itching and burning of the skin immediately after applying the gel, which eventually passes.


Overdose


When applying a large amount of gel, redness and peeling of the skin may occur. Since the drug is almost not absorbed through the skin, any systemic effect of adapalene is unlikely.


Side effects


Allergic reactions photosensitivity reactions tingling redness peeling dryness itching and burning of the skin at the site of application itching and burning of the skin are often observed immediately after applying the gel as well as exacerbation of the acne process skin irritation in the first weeks of treatment.


These phenomena are reversible and usually disappear or subside after 1 month of treatment.


Interactions with other drugs and other types of interactions


Since deriva water gel can cause a local irritant effect in some patients, the simultaneous use of other potentially irritating topical medications, including cosmetics, increases the risk of undesirable effects on the skin.


It should be used with extreme caution with drugs containing sulfur resorcinol or salicylic acid.

Tags: Deriva® [Adapalene]