ADAPALENE Drug Interactions: What You Need to Know

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.

CABTREO is contraindicated in patients with: Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components of CABTREO, or lincomycin [ see Warnings and Precautions ( 5.1 )]. A history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [ see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4 ) History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4 )

AND PRECAUTIONS Hypersensitivity : If a serious hypersensitivity reaction occurs, discontinue CABTREO immediately and initiate appropriate therapy. ( 5.1 ) Colitis : Clindamycin can cause severe colitis, which may result in death. Discontinue CABTREO if diarrhea occurs. ( 5.2 ) Photosensitivity : Avoid or minimize exposure to sunlight and sunlamps. Wear sunscreen and protective clothing when sun exposure cannot be avoided. ( 5.3 )

Skin

Irritation and Allergic Contact Dermatitis : Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of CABTREO and may necessitate discontinuation ( 5.4 )

5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with use of clindamycin phosphate, benzoyl peroxide, and adapalene <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.2 )]</span>. If a serious hypersensitivity reaction occurs, discontinue CABTREO immediately and initiate appropriate therapy.

5.2 Colitis Diarrhea, bloody diarrhea, and colitis have been reported with the use of topical and systemic clindamycin. Severe colitis has occurred with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. Discontinue CABTREO if diarrhea occurs.

5.3 Photosensitivity CABTREO may increase sensitivity to ultraviolet light. Avoid or minimize sun exposure (including use of tanning beds, and sun lamps) following CABTREO application. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided.

5.4 Skin Irritation and Allergic Contact Dermatitis Stinging/burning/pain, erythema, dryness, irritation, exfoliation, and dermatitis have been reported with use of CABTREO. These application site adverse reactions occurred at a greater frequency in CABTREO-treated subjects than in vehicle-treated subjects. These adverse reactions are most likely to occur during the first four weeks of treatment [ see Adverse Reactions ( 6.1 )] . Irritant and allergic contact dermatitis have been reported with use of CABTREO. Weather extremes, such as wind or cold, may be irritating to patients under treatment with CABTREO. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of CABTREO, or discontinue use. Avoid applying CABTREO to areas of broken, eczematous, or sunburned skin. Avoid use of “waxing” as a depilatory method on skin treated with CABTREO. Avoid concomitant use of other potentially irritating topical products such as peeling, desquamating, or abrasive agents and products with high concentrations of alcohol, astringents, spices, or limes. Use of CABTREO with concomitant topical acne therapy has not been evaluated.