Apply a thin layer to the affected area(s) once a day, at least 30 minutes before bedtime
Comments:
The affected area(s) should be washed with a mild cleanser and dried before application of this drug.
Patients should extend application of the cream to approximately 1/2 inch of normal appearing skin (surrounding each lesion), and then the cream should rubbed lightly and uniformly into the skin.
Treatment should be discontinued once control is achieved.
Use: Short-term treatment of moderate to severe melasma of the face, in combination with sun avoidance measures (e.g., sunscreen use)
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
This drug is to be used topically, and should not be given orally, ophthalmically, or intravaginally.
Moisturizers and cosmetics may be used on the affected area(s) during the day.
Storage requirements:
When not in use, this drug should be kept in a refrigerator (2 to 8C).
General:
Patients should avoid sunlight exposure, and should be instructed to use an SPF 30 sunscreen and wear protective clothing during the day.
Long-term/maintenance treatment should be avoided. Once patients achieve control of melasma, they may be switched over to other treatments; however, melasma usually recurs after discontinuation of this drug.
Safety and efficacy of this drug have not been established in patients with Fitzpatrick Skin Types V and VI; these patients may develop excessive skin bleaching.
Monitoring:
Hypersensitivity and cutaneous reactions
Hypothalamus-pituitary-adrenal axis suppression, especially in patients receiving long-term therapy
Patient advice:
Patients should be advised to avoid concomitant photosensitizing drugs.
Patients should told to avoid concomitant use of medicated/abrasive soaps/cleansers, drying soaps/cosmetics, products with high concentrations of alcohol/astringents, and other irritant/keratolytic drugs.
Patients should be instructed to contact their healthcare provider if hypersensitivity reactions or exogenous ochronosis occurs.
