TRI-LUMA®
(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® (try-LOOM-ah),
ask your doctor. Only your doctor can determine if TRI-LUMA® is right for
you.
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 (hyperpigment-ed) spots on facial skin, especially
on the cheeks and forehead. This condition usually happens with hormone changes.
TRI-LUMA® 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® 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® 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® 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® Cream on and off, whenever
their melasma comes back until it clears. About 300 patients used TRI-LUMA®
Cream intermittently (not continuously) for 180 days, and majority of the side
effects were mild in severity. 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 nonprescription 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.
Last updated on RxList: 10/10/2008