TRI-LUMA CREAM [SIN12607P]

Product Info

TRI-LUMA CREAM

[SIN12607P]

INDICATIONS AND USAGE

TRI-LUMA cream is indicated for 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:

• 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.

• 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.

• 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.

• The safety and efficacy of TRI-LUMA Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.

• 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. Therefore, it is not recommended for use in pregnant women. (See PRECAUTIONS, Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 excessive sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.

Therapeutic effects may be observed as early as 4 weeks. Treatment should be discontinued when melasma is resolved. When melasma recurs, treat with TRI-LUMA cream until the condition clears.

CONTRAINDICATIONS:
TRI-LUMA Cream is contraindicated in individuals with a history of hypersensitivity, allergy, or intolerance to this product or any of its components, in pregnancy, and in women planning a pregnancy.