These doses are two and four times the maximum human systemic dose, when adjusted for total body surface area. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. A dose-related incidence of liver tumors in male mice was observed at those same doses. In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.Ĭarcinogenesis, Mutagenesis, Impairment to Fertility If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Topical use may induce severe local erythema and peeling at the site of application. RETIN-A (tretinoin) acne treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued.
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