Adaben Duo Gel: Each gram gel contains 1 mg Adapalene BP (0.1%) and 25 mg Benzoyl peroxide BP (2.5%).
Adaben Duo Gel is a combination product for topical use containing Adapalene (a synthetic retinoid) and Benzoyl peroxide.
Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of Adapalene for the treatment of acne is unknown.
Benzoyl peroxide has sebostatic and keratolytic activity counteracting the hyperkeratinisation and excessive sebum secretion associated with acne vulgaris. It has antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris.
Adaben Duo Gel is indicated for the topical treatment of acne vulgaris.
Persons 12 years of age and older apply a thin film of Adaben Duo Gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g. forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adaben Duo Gel is not for oral, ophthalmic, or intravaginal use.
Pediatric Use: Safety and effectiveness of Adaben Duo Gel in pediatric patients under the age of 12 have not been established.
Adaben Duo Gel is usually a well tolerated preparation. But the local adverse reactions that may be observed are dry skin, erythema, pruritus of skin, skin scaling, skin rash etc.
Exposure to sunlight (ultraviolet ray), including sunlamps, should be minimized during the use of this preparation. Use of sunscreen products and protective apparel, (e.g. hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with Adaben Duo Gel.
Pregnancy: Pregnancy category C. There are no well-controlled trials in pregnant women treated with Adaben Duo Gel.
Lactating mother: It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adaben Duo Gel is administered to a lactating mother.