Adapalene / Benzoyl Peroxide

What it is and how it works

Mechanism of Action Adapalene 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 Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.

Indications

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

Dosage and administration (summary)

• For topical use only. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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). • Wash hands after application as Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% may bleach hair or colored fabrics. • Avoid the eyes, lips and mucous membranes. • For topical use only • Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral, ophthalmic, or intravaginal use.

Contraindications

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. • Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%.

Warnings and precautions

• Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products. • Photosensitivity: Avoid exposure to sunlight and sunlamps. Wear broad spectrum sunscreen and protective clothing when sun exposure cannot be avoided. • Skin Irritation: Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% and may necessitate discontinuation.

Pregnancy

Pregnancy Risk Summary Available pharmacovigilance data with Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with the combination gel.

Storage and supply

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as a 45 gram pump (NDC 63629-9322). Storage and handling • Store at controlled room temperature 20° – 25°C (68° – 77°F) with excursions permitted to 15° – 30°C (59° – 86°F) . • Keep away from heat.

Source: Adapalene And Benzoyl Peroxide (Adapalene And Benzoyl Peroxide) — US FDA prescribing information, 2024-01-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.