Deriva aqueous gel

INSTRUCTIONS for medical use of the medicinal product DERIVAA AQUEOUS GEL (DERIVAAQUEOUSGEL)

Composition:

Active substance: adapalene;

1 g of gel contains 1 mg of adapalene;

Excipients: disodium edetate, carbomer 940, propylene glycol, methylparahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: white, homogeneous, opaque gel.

Pharmacotherapeutic group.

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

ATC code D10AD03.

Pharmacological Properties

Pharmacodynamics. Adapalene is a naphthoic acid derivative and a retinoid-like substance that modulates cellular differentiation, keratinization, and inflammatory processes in the skin—key pathogenic factors in the development of acne. Adapalene binds to nuclear retinoid receptors, thereby promoting normal differentiation of follicular epithelial cells. This leads to a reduction in microcomedo formation and prevents the development of acne, helping maintain intact skin.

Pharmacokinetics. The therapeutic effect of the drug usually becomes apparent within 8–12 weeks after the start of treatment. When adapalene is applied as a gel, the extent of absorption through the skin into the bloodstream is extremely low.

Clinical characteristics.

Indications.

Local treatment of common acne (acne vulgaris).

Contraindications.

Hypersensitivity to adapalene or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Since Deriva aqueous gel may cause local irritant effects in some patients, simultaneous use of other potentially irritating topical agents, including cosmetic products, increases the risk of undesirable skin effects.

Particular caution should be exercised when prescribing the medicinal product together with products containing sulfur, resorcinol, or salicylic acid.

Special precautions for use

The product is intended for topical use only. Contact of the gel with the eyes, lips, nostrils, and the skin around the eyes as well as with mucous membranes should be avoided. If the gel comes into contact with these areas, they should be thoroughly rinsed with warm water. Do not apply the gel to areas with eczematous skin lesions, sunburns, cuts, or other skin injuries. During treatment, excessive exposure to sunlight and ultraviolet light, including tanning lamps, should be avoided due to increased skin sensitivity and a higher risk of developing sunburn erythema.

The use of cosmetic products that dry the skin (such as abrasive or medicated soaps, skin cleansers, products containing high amounts of alcohol, astringents, creams or lotions for shaving or after-shaving, detergents) during treatment may cause an irritant effect.

If allergic reactions occur during treatment with the product, therapy should be discontinued and medical advice should be sought.

Use during pregnancy or breastfeeding

The product should not be used during pregnancy, as adequate clinical trials on the safety of adapalene use in pregnant women have not been conducted. It is unknown whether adapalene is excreted in breast milk; therefore, use of the product during breastfeeding is not recommended.

Ability to influence reaction speed when driving or operating machinery

Since systemic absorption of the product through the skin is negligible, the effect of the active substance on reaction speed is unlikely.

Dosage and Administration

Differin aqueous gel should be used for topical treatment of acne in adults and children aged 12 years and older. The gel should be applied once daily, at bedtime, in a thin layer to clean, dry skin at sites of acne lesions.

During the first weeks of treatment, an acne flare-up may occur due to the active ingredient's effect on previously invisible lesions. In such cases, treatment should not be discontinued, as therapeutic effect is typically observed after 8–12 weeks of treatment initiation. Additionally, transient sensations of itching and burning of the skin may occur immediately after gel application, which usually diminish with time.

Children

The safety and efficacy of the drug in children under 12 years of age have not been established; therefore, the drug should not be used in this age group.

Overdose

Application of a large amount of gel may cause skin redness and peeling. Since absorption of the drug through the skin is negligible, any systemic effects of adapalene are unlikely.

Adverse Reactions.

Allergic reactions, photosensitivity reactions, sensation of pruritus, erythema, peeling, dryness, itching and burning of the skin at the application site. Itching and burning of the skin are frequently observed immediately after application of the gel, as well as exacerbation of acne lesions and skin irritation during the first weeks of treatment.

These phenomena are reversible and usually diminish or disappear after one month of treatment.

Shelf Life.

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.

Supply Classification.

Over-the-counter (without prescription).

Manufacturer.

Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.

Manufacturer's Address and Place of Business.

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India / Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India.