fluocinolone/tretinoin/hydroquinone (Tri-Luma)

Dosing and uses of Tri-Luma (fluocinolone/tretinoin/hydroquinone)

• Adult
• Pediatric

 

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