IMPORTANT SAFETY INFORMATION
Indication : TRI‐LUMA ® Cream is indicated for the short‐term (up to 8 weeks) treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens. Adverse Events : In the controlled clinical trials, the most frequently reported events were redness, peeling, burning, dryness, and itching at the site of application. Warnings/Precautions : TRI‐LUMA contains sulfites which may cause severe, life‐threatening allergic reactions in people allergic to sulfites. TRI‐LUMA contains hydroquinone, which may cause a gradual blue‐black darkening of the skin. If you are pregnant, nursing or trying to become pregnant you should not use TRI‐LUMA. Safety and efficacy have not been established in individuals with darker skin. Reversible HPA axis (adrenal function) suppression may result from exposure to the topical corticosteroid, fluocinolone acetonide, so discontinue use if signs and symptoms of this condition occur. Avoid products that may dry or irritate the skin, such as abrasive cleansers, scrubs, or skin‐peeling agents. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. If exposure cannot be avoided, sunscreen products [SPF 30 or more] and protective apparel should be used.
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Sixty-three pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone Dipropionate Cream was applied twice daily for 2 to 3 weeks over a mean body surface area of 40% (range 35% to 90%). In 10 of 43 (23%) evaluable patients, adrenal suppression was indicated by either a ≤ 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤ 18 mcg/dL and/or an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with Betamethasone Dipropionate Cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.