Adapalene

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

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.

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.

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.