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warnings
WARNINGS • Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic long-term use are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with Tretinoin Cream, USP (Emollient) 0.05% for longer than 48 weeks. The significance of these findings is unknown. • Safety and effectiveness of Refissa in individuals with moderately or heavily pigmented skin have not been established. • Refissa should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Refissa. Patients with sunburn should be advised not to use Refissa until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation and those patients with inherent sensitivity to sunlight, should exercise particular caution when using Refissa and assure that the precautions outlined in the Patient Package Insert are observed. Tretinoin Cream, USP (Emollient) 0.05% should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution in patients with this condition. Application of larger amounts of medication than recommended will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.
ADVERSE REACTIONS (See WARNINGS and PRECAUTIONS sections.) In double-blind, vehicle-controlled studies involving 179 patients who applied Tretinoin Cream, USP (Emollient) 0.05% to their faces, adverse reactions associated with the use of Tretinoin Cream, USP (Emollient) 0.05% were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of Tretinoin Cream, USP (Emollient) 0.05% because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions. Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with Tretinoin Cream, USP (Emollient) 0.05%. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.