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INDICATIONS AND USAGE
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 intermit-tent 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 (See PRECAUTIONS, Pregnancy).
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DOSAGE AND ADMINISTRATION
TRI-LUMA® Cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime.
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. Do not use occlusive dressing.
During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.
Therapeutic effects may be observed as early as 4 weeks. Use TRI-LUMA® Cream daily for as long as the melasma lesions persist. Treatment should be discontinued when melasma is resolved. When melasma recurs, retreat with TRI-LUMA® Cream until the condition clears.
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HOW SUPPLIED
TRI-LUMA® Cream is supplied in 30 g aluminum tubes, NDC 0299-5950-30.
Storage: Keep tightly closed. Store at controlled room temperature 68° to 77°F (20°-25°C).
Protect from freezing.
Marketed by:
GALDERMA LABORATORIES, L.P., Fort Worth, TX 76177 USA
GALDERMA is a registered trademark.
www.triluma.com
Manufactured by:
Hill Laboratories, Inc., Sanford, FL 32773 USA
20024-1203 Revised: December 2003
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