Adapalene

Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.

Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Adapalene Cream, 0.1% should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Cream, 0.1%.

Adapalene Cream, 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

General Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of Adapalene Cream, 0.1%. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use. If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution.

In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used Adapalene Cream, 0.1% once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with Adapalene Cream, 0.1% from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with Adapalene Cream, 0.1% from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% ‹1%. Scaling 58% (166) 35% (100) 6% ‹1%. Dryness 48% (136) 42% (121) 9% ‹1%. Pruritus (persistent) 74% (211) 21% 4% ‹1%. Burning/Stinging (persistent) 71% (202) 24% 4% ‹1%.

As Adapalene Cream, 0.1% has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Adapalene Cream, 0.1%. If these preparations have been used, it is advisable not to start therapy with Adapalene Cream, 0.1% until the effects of such preparations in the skin have subsided.

Store at controlled room temperatures 68˚ to 77˚F (20˚ - 25˚C) with excursions permitted between 59˚ and 86˚F (15˚ - 30˚C). Protect from freezing.