Fluocinolone 0.01% + Hydroquinone 4% + Tretinoin 0.05% Topical

Indications

Fluocinolone 0.01% + Hydroquinone 4% + Tretinoin 0.05% Topical is used for: Melasma

Adult Dose

Topical/Cutaneous Moderate to severe melasma of the face Adult: Apply a thin layer onto the hyperpigmented areas of melasma once daily, 30 minutes before bedtime. Treatment duration should not exceed 8 wk.

Child Dose

Renal Dose

Administration

Wash face gently before application; rinse & pat dry Apply thin film to hyperpigmented area & 1/2 inch surrounding skin Do not use occlusive dressing

Contra Indications

A history of hypersensitivity, allergy, or intolerance to this product or any of its components.

Precautions

Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation such as skin reddening, peeling, mild burning sensation, dryness, and pruritus. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. Cream also contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, Cream should be discontinued. Lactation: not known whether excreted in breast milk; use caution

Pregnancy-Lactation

Pregnancy Category: C Lactation: not known whether excreted in breast milk; use caution

Interactions

Medicated or abrasive soaps & cleansers, soaps & cosmetics w/ drying effects, products w/ high conc of alcohol & astringent, & other irritants or keratolytic drugs. Medications w/ photosensitizing effects.

Adverse Effects

Side effects of Fluocinolone 0.01% + Hydroquinone 4% + Tretinoin 0.05% Topical : >10% Erythema (41-45%), Desquamation (36-40%), Burning (16-20%), Dryness (11-15%), Pruritis (11-15%) 1-10% Acne (5%)

Mechanism of Action

Fluocinolone acetonide is a synthetic fluorinated corticosteroid that is used topically for its anti-inflammatory, anti-pruritic and vasoconstrictive properties. Hydroquinone is used as a depigmenting agent. Tretinoin is a retinoid that is appears to stimulate mitosis, increases turnover of follicular epithelial cells and reduces their cohesiveness.