TRI-LUMA SUMMARY
TRI-LUMA® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a hydrophilic cream base for topical application.
TRI-LUMA® Cream is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
The following are important statements relating to the indication and usage of TRI-LUMA® Cream:
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TRI-LUMA® Cream, a combination drug product containing corticosteroid, retinoid, and bleaching agent, was proven safe for the intermittent treatment of melasma, with cumulative treatment time of at least 180 days. Because melasma usually recurs upon discontinuation of TRI-LUMA® Cream, patients can be re-treated with TRI-LUMA® until melasma is resolved. Patients need to avoid sunlight exposure, use sunscreen with appropriate SPF, wear protective clothing, and change to non-hormonal forms of birth control, if hormonal methods are used.
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In clinical trials used to support the use of TRI-LUMA® Cream in the treatment of melasma, patients were instructed to avoid sunlight exposure to the face, wear protective clothing and use a sunscreen with SPF 30 each day. They were to apply the study medication each night, after washing their face with a mild soapless cleanser.
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The safety and efficacy of TRI-LUMA® Cream in patients of skin types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded.
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The safety and efficacy of TRI-LUMA® Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.
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Because pregnant and lactating women were excluded from, and women of child-bearing potential had to use birth control measures in the clinical trials, the safety and efficacy of TRI-LUMA® Cream in pregnant women and nursing mothers have not been established PRECAUTIONS, Pregnancy).
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