What Tri-Luma is used for and how to use it
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Tri-Luma - Consumer Medicine Information

Manufacture: Galderma Laboratories
Country: Canada
Condition: Melasma
Class: Topical depigmenting agents
Form: Cream, gel, liniment or balm, lotion, ointment, etc
Ingredients: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%, 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

(fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%)

What is the Most Important Information I Should Know About Tri-Luma Cream

Use of TRI-LUMA 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 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 Cream, tell your doctor right away. You should discuss the chances that your baby may be harmed. Using TRI­ LUMA Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

What is Tri-Luma Cream

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

TRI-LUMA Cream is for SHORT-TERM (up to 8 weeks) treatment of moderate tosevere melasma of the face. It is NOT FOR LONG-TERM (more than 8 weeks) or maintenance (continuous) treatment of melasma. 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 studies, after 8 weeks of treatment with TRI-LUMA Cream, most patients had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another). In most patients treated with TRI-LUMA Cream, their melasma came back after treatment. If the underlying cause 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. TRI-LUMA Cream may improve your melasma, but it is NOT a cure.

Who Should not Use Tri-Luma Cream

Do not use TRI-LUMA 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

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 Cream will be greater than the risks. If possible, delay treatment with TRI­ LUMA Cream until after the baby is born.

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

How Should I Use Tri-Luma Cream

TRI-LUMA 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 Cream at night, at least 30 minutes before bedtime.
  • Put a small amount (pea sized or 1/2 inch or less) of TRI-LUMA 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 Cream or apply it more often than recommended by your doctor. Too much TRI-LUMA 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 Cream.
  • If your skin gets too irritated, stop using TRI-LUMA 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 Cream until your skin is healed.

After stopping TRI-LUMA treatment, continue to protect your skin from sunlight.

What Should I Avoid While Using Tri-Luma 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 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 Cream.

Heat, wind and cold. Heat and cold tend to dry or irritate normal skin. Skin treated with TRI-LUMA 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 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.

What are the Possible Side Effects of Tri-Luma Cream

A very few patients may get severe allergic reactions from TRI-LUMA. 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 Cream, your skin may develop mild to moderate redness, peeling, burning, dryness, or itching.

TRI -LUMA 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 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 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 for a condition for which it was not prescribed. Do not give TRI -LUMA 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. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TRI-LUMA that is written for health professionals.

Ingredients

TRI-LUMA 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.

Marketed By

GALDERMA LABORATORIES, L.P.

Fort Worth, TX 76177 USA

Manufactured By

Hill Dermaceuticals, Inc.

Sanford, FL 32773 USA

or

Manufactured By

G Production Inc.

Baie d’Urfé, QC, H9X 3S4 Canada

Made in Canada.