Dosing & Uses
Dosage Forms & Strengths
Indicated for short-term treatment of moderate to severe melasma
Apply to face qHS, at least 30 min before bedtime
Wash face gently before application; rinse & pat dry
Apply thin film of Tri-Luma to hyperpigmented area & 1/2 inch surrounding skin
Do not use occlusive dressing
Safety & efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Not indicated for maintenance treatment of melasma
Avoid sun exposure
Safety & efficacy of Tri-Luma in pts of skin types V and VI not studied. Excessive bleaching in pts with darker skin cannot be excluded.
Safety & efficacy in Tx of hyperpigmentation conditions other than melasma of face not studied
Contains sodium matabisulfite which may cause allergic-type reactions in susceptible pts.
Hydroquinone may produce exogenous ochronosis (darkening of skin)- promptly discontinue if occurs
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known whether excreted in breast milk; use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Hydroquinone: Inhibits melanocyte metabolic processes that produce melanin; incr excretion of melanin from melanocytes
Fluocinolone: Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes
Tretinoin: Follicular epithelium irritant
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