Retinoic Acid Derivative; Vitamin A Derivative; Vitamin, Topical

Treatment of solar lentigines; the efficacy of using Solagé™ daily for >24 weeks has not been established. The local cutaneous safety of Solagé™ in non-Caucasians has not been adequately established.

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May cause fetal harm when administered to a pregnant woman. It is unknown if mequinol or tretinoin are excreted in breast milk. Use caution in breast-feeding.

Pregnancy, women of childbearing potential, hypersensitivity to mequinol, tretinoin, or any component

Discontinue if hypersensitivity is noted. Use extreme caution in eczematous skin conditions. Safety and efficacy have not been established in moderately or heavily pigmented skin. Not to be taken with photosensitizing drugs (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides). Avoid sun (including sun lamps) or use protective clothing. Do not use in sunburned patients until they have fully recovered. Use extreme caution in patients who have significant exposure to the sun through their occupation. Use caution in patient with history or family history of vitiligo. For external use only. Weather extremes (wind, cold) may be irritating to users of Solagé™. Do not use in pediatric patients. No bathing or showering for at least 6 hours after application. Effects of chronic use (>52 weeks) are unknown.

>10%: Dermatologic: Erythema (49%), burning, stinging or tingling (26%), desquamation (14%), pruritus (12%),

1% to 10%: Dermatologic: Skin irritation (5%), hypopigmentation (5%), halo hypopigmentation (7%), rash (3%), dry skin (3%), crusting (3%), vesicular bullae rash (2%), contact allergic reaction (1%)

Excessive topical application will lead to marked redness, peeling, discomfort or hypopigmentation. Oral ingestion may lead to the adverse events seen in vitamin A overdose. If oral ingestion occurs, the patient should be monitored and appropriate supportive measures used as necessary. In rats who ingested 5 mL/kg, the signs of toxicity were of alcohol (high alcohol content in formulation).

Topical products with skin drying effects (eg, those containing alcohol, astringents, spices, or lime; medicated soaps or shampoos; permanent wave solutions; hair depilatories or waxes; and others) may increase skin irritation. Avoid concurrent use.

Photosensitizing drugs (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) can further increase sun sensitivity. Avoid concurrent use.

Store at controlled room temperature (15°C to 30°C / 59°F to 86°F); flammable, keep away from heat and open flame

Solar lentigines are localized, pigmented, macular lesions of the skin on areas of the body chronically exposed to the sun. Mequinol is a substrate for the enzyme tyrosinase and acts as a competitive inhibitor of the formation of melanin precursors. The mechanisms of depigmentation for both drugs is unknown.

Peak effect: Mean C_max for mequinol was 9.9 ng/mL

Absorption: Percutaneous absorption was 4.4% of tretinoin when applied as 0.8 mL of Solagé™ to a 400 cm² area of the back; the T_max for mequinol was 2 hours

Adults: Topical: Apply twice daily to solar lentigines using the applicator tip while avoiding application to the surrounding skin. Separate application by at least 8 hours or as directed by physician.

Avoid eyes, mouth, paranasal creases, and mucous membranes when applying

No information available to require special precautions

No effects or complications reported

No bathing or showering for at least 6 hours after application. Avoid eyes, mouth, paranasal creases, and mucous membranes when applying. Application of larger amounts or more frequently will not result in more rapid or better results. Follow application directions closely. Wait 30 minutes after use before applying cosmetics. Avoid sun exposure (including sun lamps) or use protective clothing. Some reappearance of freckles may occur after discontinuation. After application, short-term stinging, burning, or irritation may occur.

Educate patient about sun avoidance or use of protective clothing. If patient experiences significant local irritation (redness, burning, stinging, peeling, or itching) then direct patient to use less medication, decrease frequency of use, discontinue temporarily, or discontinue altogether.

Liquid, topical: Mequinol 2% and tretinoin 0.01% (30 mL)