TRI-LUMA® (hydroquinone 4% cream)
(fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream

Read this information carefully before you begin treatment. Read the information you get whenever you get more medicine. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about TRI-LUMA® (hydroquinone 4% cream) (try-LOOM-ah), ask your doctor. Only your doctor can determine if TRI-LUMA® (hydroquinone 4% cream) is right for you.

What is the most important information I should know about TRI-LUMA® (hydroquinone 4% cream) Cream?

Use of TRI-LUMA® (hydroquinone 4% cream) Cream in pregnant women may carry the chance of having birth defects in the baby. Tell your doctor if you are pregnant, may be pregnant, or plan to become pregnant. Your doctor will talk with you about the benefits and risks of using TRI-LUMA® (hydroquinone 4% cream) during pregnancy to help decide if the benefits for you are greater than the risks. You may decide to delay treatment until after your baby is born.

If you become pregnant while taking TRI-LUMA® (hydroquinone 4% cream) Cream, tell your doctor right away. You should discuss the chances that your baby may be harmed. Using TRI-LUMA® (hydroquinone 4% cream) Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

What is TRI-LUMA® (hydroquinone 4% cream) Cream?

TRI-LUMA® (hydroquinone 4% cream) (try-LOOM-ah) Cream is a medicine with three active components. You put TRI-LUMA® (hydroquinone 4% cream) Cream on your face to treat a skin condition called melasma. Melasma consists of dark (hyperpigment-ed) spots on facial skin, especially on the cheeks and forehead. This condition usually happens with hormone changes.

TRI-LUMA® (hydroquinone 4% cream) Cream is for short-term and intermittent long-term treatment of moderate to severe melas-ma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. TRI-LUMA® (hydroquinone 4% cream) Cream showed a significantly favorable safety profile for the long-term treatment of melas-ma, up to 6 months. Milder forms of melasma may not need treatment with medicine. Melasma can also be managed by staying out of the sun or by stopping the use of birth control methods that involve hormones.

In clinical studies, after 8 weeks of treatment with TRI-LUMA® (hydroquinone 4% cream) Cream, most patients had improvements, with 42 (26%) out of 161 patients experiencing complete clearing of their melasma. In most patients treated with TRI-LUMA® (hydroquinone 4% cream) Cream, melasma came back after treatment was stopped. If the underlying causes of melasma, such as the use of certain birth control pills or too much exposure to sunlight, are not removed, melasma will come back when you stop treatment. In the long-term studies, patients were treated with TRI-LUMA® (hydroquinone 4% cream) Cream on and off, whenever their melasma comes back until it clears. About 300 patients used TRI-LUMA® (hydroquinone 4% cream) Cream intermittently (not continuously) for 180 days, and majority of the side effects were mild in severity. TRI-LUMA® (hydroquinone 4% cream) Cream may improve your melasma, but it is NOT a cure.

Who should not use TRI-LUMA® (hydroquinone 4% cream) Cream?

Do not use TRI-LUMA® (hydroquinone 4% cream) if you are allergic to the medicine or any of its ingredients. See the end of this leaflet for a list of ingredients.

What should I tell my doctor before taking TRI-LUMA® (hydroquinone 4% cream) ?

If you are pregnant, think you are pregnant, plan to be pregnant or are nursing an infant, tell your doctor. Your doctor will decide with you whether the benefits in using TRI-LUMA® (hydroquinone 4% cream) Cream will be greater than the risks. If possible, delay treatment with TRI-LUMA® (hydroquinone 4% cream) Cream until after the baby is born.

Tell your doctor about all the other medicines and skin products you use, including prescription and nonprescription medicines, cosmetics, and supplements. They may make your skin more sensitive to sunlight.

How should I use TRI-LUMA® (hydroquinone 4% cream) Cream?

TRI-LUMA® (hydroquinone 4% cream) Cream should be used as instructed by your doctor.

To help you use the medicine correctly, follow these steps:

• Gently wash your face with a mild cleanser. Don't use a wash cloth to apply the cleanser, just your fingers. Rinse and pat your skin dry.
• Apply TRI-LUMA® (hydroquinone 4% cream) Cream at night, at least 30 minutes before bedtime.
• Put a small amount (pea sized or 1/2 inch or less) of TRI-LUMA® (hydroquinone 4% cream) Cream on your fingertip. Apply a thin coat onto the discolored spot(s). Include about 1/2 inch of normal skin surrounding the affected area. After you have used the medicine for a while, you may find that you need slightly less to do the job.
• Rub the medicine lightly and uniformly into your skin. The medicine should become invisible almost at once. If you can still see it, you are using too much.
• Keep the medicine away from the corners of your nose, your mouth, eyes and open wounds. Spread it away from those areas when applying it.
• Do not use more TRI-LUMA® (hydroquinone 4% cream) Cream or apply it more often than recommended by your doctor. Too much TRI-LUMA® (hydroquinone 4% cream) Cream may irritate your skin, waste medicine, and won't give you faster or better results.
• Do not cover the treated area with anything after applying TRI-LUMA® (hydroquinone 4% cream) Cream.
• If your skin gets too irritated, stop using TRI-LUMA (hydroquinone 4% cream) Cream, and let your doctor know.
• To help avoid skin dryness, you may use a moisturizer in the morning after you wash your face.
• You may also use a moisturizer and cosmetics during the day.

Use a sunscreen of at least SPF 30 and a wide-brimmed hat over the treated areas. It requires only a small amount of sunlight to worsen melasma. Melasma can get worse even if you don't get sunburn.

Only your doctor knows which other medicines may be helpful during treatment, and will tell you about them if needed. Do not use other medicines unless your doctor approves them.

If you get sunburned, stop using TRI-LUMA® (hydroquinone 4% cream) Cream until your skin is healed.

After stopping TRI-LUMA® (hydroquinone 4% cream) treatment, continue to protect your skin from sunlight.

What should I avoid while using TRI-LUMA® (hydroquinone 4% cream) Cream?

Sunlight or ultraviolet light. Too much natural sunlight or artificial sunlight from a sunlamp can cause sunburn. Dark skin patches may become darker when the skin is exposed to sunlight. You don't have to have a sunburn to make your melasma worse.

TRI-LUMA® (hydroquinone 4% cream) can make your skin more likely to get sunburn or develop other unwanted effects from the sun. Protect your skin from natural sunlight as much as possible to help prevent further darkening of existing dark patches and formation of new ones. Staying out of the sun is especially important for women who take birth control pills or hormone replacement therapy, and for people who have had dark patches in the past.

Use an effective sunscreen any time you are outside, even on hazy days. The sunscreen should have SPF (sun protection factor) of 30 or more. Use sunscreen year-round on areas of the skin that are regularly exposed to sunlight, such as your face and hands. If possible, protect the treated area from sunlight exposure.

If you spend a lot of time outside, be especially careful of sunlight. Ask your doctor what SPF level will give you the needed high level of protection. If you will be outside, wear protective clothing, including a hat.

Do not use sunlamps while you use TRI-LUMA® (hydroquinone 4% cream) Cream.

Heat, wind and cold. Heat and cold tend to dry or irritate normal skin. Skin treated with TRI-LUMA® (hydroquinone 4% cream) Cream may be more likely to react to heat and cold. Your doctor can recommend ways to manage your melasma under these conditions.

Other skin products and medicines. Avoid products that may dry or irritate your skin. These may include soaps and cleansers that are rough or cause drying; certain astringents, such as alcohol-containing products, soaps and toiletries containing alcohol, spices, or lime; or certain medicated soaps, shampoos, and hair permanent products. Do not use any other medicines with TRI-LUMA® (hydroquinone 4% cream) Cream unless you have consulted your doctor. The medicines and product you have used in the past may cause redness or peeling when used with TRI-LUMA® (hydroquinone 4% cream) .

What are the possible side effects of TRI-LUMA® (hydroquinone 4% cream) Cream?

A very few patients may get severe allergic reactions from TRI-LUMA® (hydroquinone 4% cream) . This includes people allergic to sulfites. They may have trouble breathing or severe asthma attacks, which can be life-threatening.

While you use TRI-LUMA® (hydroquinone 4% cream) Cream, your skin may develop mild to moderate redness, peeling, burning, dryness, or itching.

TRI-LUMA® (hydroquinone 4% cream) Cream contains a corticosteroid medicine as one of its active components. The following side effects have been reported with application of corticosteroid medicines to the skin: itching, irritation, dryness, infection of the hair follicles, acne, change in skin color, inflammation around the mouth, allergic skin reaction, skin infection, skin thinning, stretch marks, and sweat problems.

Stop using TRI-LUMA® (hydroquinone 4% cream) Cream and contact your doctor if you have

• severe or continued irritation, blistering, oozing, scaling, or crusting severe burning or swelling of your skin irritation of your eyes, nose, and mouth

Some patients using TRI-LUMA® (hydroquinone 4% cream) Cream develop dark spots on their skin (hyperpigmentation), tingling, increased skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, skin bumps, blisters, or tiny red lines or blood vessels showing through the skin (telangiectasia).

If you are concerned about how your skin is reacting to the medicine, call your doctor.

General information about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use TRI-LUMA® (hydroquinone 4% cream) for a condition for which it was not prescribed. Do not give TRI-LUMA® (hydroquinone 4% cream) to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about TRI-LUMA® (hydroquinone 4% cream) . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TRI-LUMA (hydroquinone 4% cream) ® that is written for health professionals.

Ingredients: TRI-LUMA® (hydroquinone 4% cream) Cream contains fluocinolone acetonide, hydroquinone, and tretinoin as active ingredients, as well as the following in the cream base: butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid and stearyl alcohol.

Last reviewed on RxList: 10/10/2008
This monograph has been modified to include the generic and brand name in many instances.