Instructions for Deriva water gel 1 mg/g tube 15 g
Composition
active ingredient: adapalene;
1 g of gel contains 1 mg of adapalene;
Excipients: disodium edetate, carbomer 940, propylene glycol, methyl parahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.
Dosage form
Gel.
Main physicochemical properties: white, homogeneous, opaque gel.
Pharmacotherapeutic group
Acne Treatment Drugs. Retinoids for Topical Acne Treatment.
ATX code D10A D03.
Pharmacological properties
Pharmacodynamics. 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 retinoid receptors in the cell nucleus and thus promotes normal differentiation of follicular epithelial cells, which leads to a decrease in the formation of microcomedones and prevents the development of acne, helps to preserve intact skin.
Pharmacokinetics. The therapeutic effect of the drug is usually manifested within 8-12 weeks from the start of treatment. When using adapalene in the form of a gel, the degree of absorption of the drug through the skin into the blood is extremely low.
Indication
Topical treatment of common acne (acne vulgaris).
Contraindication
Hypersensitivity to adapalene or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Since Deriva aqueous gel may cause local irritation in some patients, concomitant use of other potentially irritating topical medications, including cosmetics, increases the risk of adverse skin effects.
Special caution should be exercised when prescribing the drug with drugs containing sulfur, resorcinol, or salicylic acid.
Application features.
The drug is intended for topical use only. Avoid contact of the gel with the eyes, lips, nasal wings and the skin around the eyes, as well as with mucous membranes. If the gel gets on these areas, they should be thoroughly washed 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 sensitivity and an increased risk of solar erythema.
The use of cosmetics that dry the skin (such as abrasive or medicated soaps, skin cleansers, products containing excessive amounts of alcohol, astringents, creams or lotions for or after shaving, detergents) during treatment with the drug may cause an irritating effect.
In case of allergy during treatment with the drug, therapy should be discontinued and a doctor should be consulted.
Use during pregnancy or breastfeeding.
Do not use the drug during pregnancy, as adequate clinical trials on the safety of adapalene in pregnant women have not been conducted. It is not known whether adapalene is secreted into breast milk, therefore use of the drug during breastfeeding is not recommended.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Since the drug is almost not absorbed through the skin, the effect of the active substance on the rate of reactions is unlikely.
Interaction with other medicinal products and other types of interactions
Since Deriva aqueous gel may cause local irritation in some patients, concomitant use of other potentially irritating topical medications, including cosmetics, increases the risk of adverse skin effects.
Special caution should be exercised when prescribing the drug with drugs containing sulfur, resorcinol, or salicylic acid.
Application features
The drug is intended for topical use only. Avoid contact of the gel with the eyes, lips, nasal wings and the skin around the eyes, as well as with mucous membranes. If the gel gets on these areas, they should be thoroughly washed 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 sensitivity and an increased risk of solar erythema.
The use of cosmetics that dry the skin (such as abrasive or medicated soaps, skin cleansers, products containing excessive amounts of alcohol, astringents, creams or lotions for or after shaving, detergents) during treatment with the drug may cause an irritating effect.
In case of allergy during treatment with the drug, therapy should be discontinued and a doctor should be consulted.
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy, as adequate clinical trials on the safety of adapalene in pregnant women have not been conducted. It is not known whether adapalene is secreted into breast milk, therefore use of the drug during breastfeeding is not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
Since the drug is almost not absorbed through the skin, the effect of the active substance on the rate of reactions is unlikely.
Method of administration and doses
Deriva water gel should be used for the topical treatment of acne in adults and children over 12 years of age. The gel should be applied in a thin layer to clean, dry skin in the areas of the rash once a day, at night.
During the first weeks of treatment, the acne process may worsen due to the effect of the active substance on previously invisible lesions. In this case, treatment should not be stopped, the therapeutic effect is observed 8-12 weeks after the start of treatment. It is also possible to feel itching and burning of the skin immediately after applying the gel, which disappears over time.
Children.
The safety and efficacy of the drug in children under 12 years of age have not been studied, therefore the drug should not be used in children of this age group.
Overdose
If a large amount of gel is applied, redness and peeling of the skin may occur. Since absorption of the drug through the skin is almost non-existent, any systemic effect of adapalene is unlikely.
Adverse reactions
Allergic reactions, photosensitivity reactions, tingling sensation, 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 weaken after one month of treatment.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Do not freeze.
Packaging
15 g in a tube, 1 tube in a cardboard box.
Side effects
Allergic reactions, photosensitivity reactions, tingling sensation, 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 weaken after one month of treatment.
Vacation category
Without a prescription.
Producer
Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.
Location of the manufacturer and address of its place of business
Plot No. E-37/39, MIDC, Industrial Estate, Satpur, Nasik – 422 007, India.
Address
Plot No. E-37/39, MIDC, Industrial Estate, Satpur, Nasik – 422 007, India.
