fluocinolone/tretinoin/hydroquinone (Tri-Luma)
Classes: Corticosteroids, Topical; Depigmenting Agents
Dosing and uses of Tri-Luma (fluocinolone/tretinoin/hydroquinone)
Adult dosage forms and strengths
fluocinolone/tretinoin/hydroquinone
cream
- (0.01%/4%/0.05%)/30g
Melasma
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
Pediatric dosage forms and strengths
Safety & efficacy not established
Tri-Luma (fluocinolone/tretinoin/hydroquinone) adverse (side) effects
>10%
Erythema (41-45%)
Desquamation (36-40%)
Burning (16-20%)
Dryness (11-15%)
Pruritis (11-15%)
1-10%
Acne (5%)
Warnings
Contraindications
Hypersensitivity
Cautions
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 and lactation
Pregnancy category: C
Lactation: not known whether excreted in breast milk; use caution
Pregnancy categories
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.
Pharmacology of Tri-Luma (fluocinolone/tretinoin/hydroquinone)
Absorbed: minimaL
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