Apalene 0.1% Cream: Each gram cream contains Adapalene INN 1 mg.
Adapalene is a retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a potent modulator of cellular differentiation, keratinisation and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Adapalene binds to specific retinoic acid nuclear receptors that normalises the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Apalene cream is indicated for the topical treatment of acne vulgaris of the face, chest or back.
A thin film topical cream should be applied to the affected areas once a day before bedtime, after washing. The affected areas should be dry before application.
Local reactions include burning, erythema, stinging, pruritus, dry or peeling skin. Increased sensitivity to UVB light or sunlight occurs.
Apalene cream should not come into contact with the eyes, lips mouth and mucous membranes, angles of the nose or broken skin (cuts and abrasions). If product enters the eye, wash with warm water. Because of a potential for increased irritation Apalene cream should not be used by patients with eczema or seborrhoeic dermatitis. If a reaction suggesting severe irritation occurs, discontinue use of the medication. If the irritation is not severe, use the medication less frequently, discontinue use temporarily until symptoms subside, or discontinue use altogether.
Pregnancy: Category C. There are no well-controlled studies in pregnant women.
Nursing Mothers: It is not known whether Adapalene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Apalene 0.1% cream is administered to a lactating mother.