Fluocinolone/hydroquinone/tretinoin

What is Fluocinolone/hydroquinone/tretinoin?

• Fluocinolone/hydroquinone/tretinoin (Tri-luma; Triderma) is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) used for the short-term treatment of moderate to severe melasma of the face.

Fluocinolone acetonide

Hydroquinone 200

Hydroquinone ball and spoke

Tretinoin structure

Tretinoin molecule

What are the uses of this medicine?

• Fluocinolone/hydroquinone/tretinoin (Tri-luma; Triderma) is a prescription medicine used for the short-term treatment of moderate to severe melasma of the face, in combination with sun avoidance and the use of sunscreens.

Limitations of Use:

• Tri-luma Cream is not for continuous treatment of melasma.
• It is not known if Tri-luma Cream is safe and effective in children.
• It is not known if Tri-luma Cream is safe and effective in people with dark brown to black skin color.
• It is not known if Tri-luma Cream is safe and effective in the treatment of dark spots (hyperpigmentation) of the skin caused by conditions other than melasma of the face.

How does this medicine work?

• The mechanism of action of the active ingredients in Tri-luma Cream in the treatment of melasma is unknown.
• It is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid).

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• are allergic to it or any of the ingredients in Tri-luma Cream.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Fluocinolone/hydroquinone/tretinoin (Tri-luma) approved by the United States Food and Drug Administration in the year of 2002.

How should this medicine be used?

Recommended dosage:

• Apply a thin film of Tri-luma Cream to the effected area once daily, at least 30 minutes before bedtime.
• During the day, use a sunscreen of SPF 30, and wear protective clothing.
• Avoid sunlight exposure.
• Patients may use moisturizers and/or cosmetics during the day.

Administration:

• Use Tri-luma Cream exactly as your doctor tells you to use it.
• Before you apply Tri-luma Cream, gently wash your face with a mild cleanser. Rinse your face and pat your skin dry.
• Apply Tri-luma Cream 1 time a day, at least 30 minutes before bedtime.
• Apply a thin layer of Tri-luma Cream to the affected skin areas. Include about 1/2 inch of normal skin surrounding the affected area.
• Gently rub Tri-luma Cream evenly into your skin.
• Do not get Tri-luma Cream near the corners of your mouth, your nose, your eyes, or open wounds.
• Do not bandage or cover the treated skin after applying Tri-luma Cream.
• You may use moisturizers and cosmetics during the day.
• Wash your hands after applying Tri-luma Cream.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream, 0.01%/4%/0.05%.
• Each gram of Tri-luma Cream contains 0.1 mg of fluocinolone acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin.

This medicine is available in fallowing brand namesː

• Tri-luma; Triderma

What side effects can this medication cause?

The most common side effects of this medicine include:

• redness
• peeling
• burning
• dryness
• itching
• acne

Tri-luma Cream may cause serious side effects, including:

• allergic reactions
• change in skin color
• Tri-luma Cream can pass through your skin
• skin irritation

What special precautions should I follow?

• Tri-luma Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. If anaphylaxis, asthma or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Tri-luma.
• Tri-luma Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy.
• Tri-luma Cream 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. If HPA axis suppression is noted, the use of Tri-luma Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids. The ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression.
• Cutaneous hypersensitivity to the active ingredients of Tri-luma Cream has been reported in the literature. Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on Tri-luma Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
• You should avoid sunlight, sunlamps, tanning beds, and ultraviolet light during treatment with Tri-luma Cream.
• Use a sunscreen with SPF (sun protection factor) of 30 or more. If you have to be in the sunlight, wear a wide-brimmed hat or other protective clothing to cover the treated areas.
• Melasma can get worse with even a small amount of sunlight. You should continue to avoid sunlight, use sunscreen, and wear protective clothing after treatment with Tri-luma Cream.
• Females should avoid the use of hormonal forms of birth control. Hormonal birth control methods can cause your melasma to become worse. Talk to your doctor about other birth control options.
• Heat and cold weather may irritate skin treated with Tri-luma. Talk with your doctor about ways to manage skin irritation.
• Corticosteroids, when systemically administered, appear in human milk. Care should be taken to avoid contact between the infant being nursed and Tri-luma Cream.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Tri-luma Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Tri-luma Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.

Can this medicine be used in children?

• Safety and effectiveness of Tri-luma Cream in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: fluocinolone acetonide, hydroquinone, and tretinoin
• Inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol

Who manufactures and distributes this medicine?

Marketed by:

• GALDERMA LABORATORIES, L.P.
• Fort Worth, TX USA

Manufactured by:

• Hill Dermaceuticals, Inc.
• Sanford, FL USA

What should I know about storage and disposal of this medication?

• Store Tri-luma Cream in a refrigerator, between 36°F to 46°F (2°C to 8 °C).
• Keep Tri-luma Cream tube tightly closed.
• Do not freeze Tri-luma Cream.

• Dailymed label info on Fluocinolone/hydroquinone/tretinoin
• FDA Fluocinolone/hydroquinone/tretinoin

Fluocinolone/hydroquinone/tretinoin Resources
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