Adapalene And Benzoyl Peroxide

Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

• For topical use only. Adapalene and benzoyl peroxide topical gel is not for oral, ophthalmic, or intravaginal use.
• Apply a thin layer of adapalene and benzoyl peroxide topical gel 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 may bleach hair or colored fabrics.
• Avoid the eyes, lips and mucous membranes.

Each gram of adapalene and benzoyl peroxide topical gel contains 3 mg (0.3%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to pale yellow, opaque gel. Adapalene and benzoyl peroxide topical gel is available in pumps containing 45 g or 60 g.

Available pharmacovigilance data with adapalene and benzoyl peroxide topical 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. Animal reproduction studies have not been conducted with the combination gel.

• Hypersensitivity
  : Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products. (
  
  
  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.
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• Photosensitivity
  : Avoid exposure to sunlight and sunlamps. Wear broad spectrum sunscreen and protective clothing when sun exposure cannot be avoided. (
  
  
  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.
  )
  
• 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. (
  
  
  5.3 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).
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