Adapalene

INDICATIONS AND USAGE Adapalene Topical Solution, 0.1% is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION Remove swab from foil just before using. Adapalene solution should be applied once a day to affected areas. Before retiring in the evening, wash and dry areas to be treated. Apply a thin film of medication to the affected areas. Avoid the eyes, lips, and mucous membranes. Discard swab after single use. Do not use if seal is broken. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

WARNINGS Use of Adapalene Topical Solution, 0.1% should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

CONTRAINDICATIONS Adapalene Topical Solution, 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle solution.

Drug Interactions As Adapalene Topical Solution, 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 alcohols, astringents, spices or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Adapalene Topical Solution, 0.1%. If these preparations have been used, it is advisable not to start therapy with Adapalene Topical Solution, 0.1% until the effects of such preparations in the skin have subsided.

Pregnancy Teratogenic effects Pregnancy Category C No teratogenic effects were seen in rats at oral doses of adapalene 0.15 to 5.0 mg/kg/day, up to 120 times the maximal daily human topical dose. Cutaneous route teratology studies conducted in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day, up to 150 times the maximal daily human topical dose exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate well-controlled studies in pregnant women. Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adapalene Topical Solution, 0.1% is administered to a nursing woman.

ADVERSE REACTIONS Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 30-60% of patients. Pruritus or burning immediately after application also occurs in approximately 30% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with the use of adapalene solution during clinical trials were reversible upon discontinuation of therapy. To report SUSPECTED ADVERSE REACTIONS , contact Rochester Pharmaceuticals at 1 -866-458-1772 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .