Adult Dosing
Moderate to severe melasma of the face
- Apply qhs; should be applied at least 30 minutes before bedtime
Note:
- Before applying the cream, 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 hyper-pigmented regions including about 1/2 inch of normal-appearing skin around each lesion
- Avoid occlusive dressing
- Use a sunscreen of SPF 30 and wear protective clothing to avoid sunlight exposure during the day
- May use moisturizers and/or cosmetics during the day
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Caution should be exercised in patients hypersensitive to metabisulfite because it may cause allergic-type reactions including anaphylactic symptoms and fatal asthmatic episodes in these individuals
- Promptly discontinue therapy on occurrence of exogenous ochronosis, a gradual blue-black darkening of the skin; mostly seen in Black patients but may also affect Caucasians and Hispanics
- Mild to moderate irritation such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may occur at the site of application due to the presence of hydroquinone and tretinoin in the drug
- Withdrawal of therapy may be associated with hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also occur during therapy due to systemic absorption of topical corticosteroid
- ACTH or cosyntropin stimulation test, A.M. plasma cortisol test, and urinary free cortisol test may be helpful in evaluating patients for HPA axis suppression
- Avoid exposure to sunlight, sunlamps, or ultraviolet light during treatment; wear protective clothing and use a sunscreen with SPF 30 during the day
- Apply a moisturizer to the face in the morning after washing because of the drying effect of this medication
- Weather extremes, such as heat or cold, should be avoided as this may cause irritation
- Excessive application of this medication may cause marked redness, peeling, or discomfort
Cautions: Use cautiously in
- Dark complexion
- Patients with considerable exposure to sun or skin irritants due to their occupation or habits
Supplemental Patient Information
- Advise patients to avoid application of the cream close to the eyes, nose, or angles of the mouth because the mucosa is much more sensitive than the skin to the irritant effect
Pregnancy Category:C
Breastfeeding: Fluocinolone has not been studied during breastfeeding; short-term application of topical corticosteroids (fluocinolone) is not expected to pose a risk to the breastfed infant by passage into breast milk. Use of the least potent drug on the smallest area of the mother's skin is recommended. Ensure that the infant's skin does not come into direct contact with the areas treated with the drug. Use of lower potency corticosteroids on the nipple or areola is recommended. Only water-miscible cream or gel should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is applied to the nipple or areola. Literature on the use of topical tretinoin during breastfeeding is unavailable. Due to poor absorption following topical application, tretinoin is considered a low risk to the nursing infant. Ensure that the infant's skin does not come into direct contact with the treated areas of the skin. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 April 2011). As per manufacturer’s data, caution should be exercised when administered to a nursing woman and care should be taken to avoid contact between the nursing infant and the cream.
US Trade Name(s)
US Availability
Tri-Luma (fluocinolone/hydroquinone/tretinoin)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]