Adapalene

What it is and how it works

Mechanism of Action 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.

Indications

Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ADAPALENE Gel, 0.3% is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Dosage and administration (summary)

Wash affected areas gently with a non-medicated soap. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel,0.3%. Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. For topical use only. Not for ophthalmic, oral or intravaginal use.

Contraindications

Adapalene gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel, 0.3% . Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel,0.3%

Warnings and precautions

• Allergic/ Hypersensitivity Reactions: Allergy/hypersensitivity reactions include anaphylaxis, angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue adapalene gel in the event of an allergic/hypersensitivity reaction. • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided . • Local Cutaneous Reactions: Erythema, scaling, dryness. and stinging/burning were reported with use of adapalene gel.

Pregnancy

Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Storage and supply

Adapalene Gel, USP,0.3% is supplied in the following size. 45g tube- NDC 21922-051-06 45g pump- NDC 21922-051-50 Storage : Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children.

Source: Adapalene Gel Usp, 0.3% (Adapalene Gel Usp, 0.3%) — US FDA prescribing information, 2025-09-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.