Adapalene - Warnings and Precautions

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 and may necessitate discontinuation.

5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products.

If a serious hypersensitivity reaction occurs, discontinue adapalene and benzoyl peroxide topical gel immediately and initiate appropriate therapy.

5.2 Photosensitivity Avoid exposure to sunlight, including sunlamps, during the use of adapalene and benzoyl peroxide topical gel.

Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution.

Use of broad spectrum 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 adapalene and benzoyl peroxide topical gel.

5.3 Skin Irritation/Contact Dermatitis Erythema, scaling, dryness, and stinging/burning may be experienced with use of adapalene and benzoyl peroxide topical gel.

These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication.

Irritant and allergic contact dermatitis may occur.

Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of adapalene and benzoyl peroxide topical gel, or discontinue use.

The product should not be applied to cuts, abrasions, eczematous or sunburned skin.

As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene and benzoyl peroxide topical gel.

Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices or limes).