Pronunciation:

floo-oh-SIN-oh-lone a-SEET-oh-nide, hye-droe-KWIN-one, TRET-i-noin

Brand Names:

• Tri-Luma

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Corticosteroid Combination

Pharmacologic—

Fluocinolone

Chemical—

Retinoid

Uses of This Medicine:

Fluocinolone, hydroquinone, and tretinoin topical is a combination of medicines used to treat moderate to severe melasma (skin discoloration) of the face. Melasma usually happens with hormone changes in women.

Fluocinolone is a corticosteroid (steroid medicine), hydroquinone is a bleaching agent, and tretinoin is a retinoid (related to vitamin A).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fluocinolone, hydroquinone, and tretinoin topical combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluocinolone, hydroquinone, and tretinoin topical combination in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aminocaproic Acid
• Aprotinin
• Aspirin
• Bemiparin
• Chlortetracycline
• Demeclocycline
• Doxycycline
• Eravacycline
• Lymecycline
• Macimorelin
• Meclocycline
• Methacycline
• Minocycline
• Nadroparin
• Omadacycline
• Oxytetracycline
• Palovarotene
• Rolitetracycline
• Sarecycline
• Sargramostim
• Somatrogon-ghla
• Tetracycline
• Tigecycline
• Tranexamic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fluconazole
• Ketoconazole
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing syndrome (adrenal gland disorder) or
• Diabetes or
• Glucosuria (sugar in the urine) or
• Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.

• Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite.

Proper Use of This Medicine:

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects like skin irritation. This medicine is not for long-term use.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is only for use on the skin. Do not get it in your eyes, nose, or mouth. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for the skin condition that your doctor is treating.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Wash your face and neck with water and a mild soap. Rinse well and pat dry.
• Apply a small amount of the medicine to each affected area of the skin and include about 1/2 inch of normal appearing skin around each lesion. Gently rub it in.
• Do not cover the treated area with a bandage unless you are told to do so by your doctor.

Use a sunscreen with a sun protection factor of SPF 30 or higher during the day. Wear protective clothing, such as a hat, when you are outdoors.

Moisturizers and cosmetics may be used during the day.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For melasma:
    • Adults—Apply a thin layer to the affected area(s) of the skin at least 30 minutes before bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while using this medicine, tell your doctor right away.

This medicine may cause a skin condition called exogenous ochronosis, which is a blue-black discoloration of the skin. Check with your doctor right away if you have a gradual darkening of the skin.

This medicine may make your skin more sensitive to sunlight, wind, and cold weather. Avoid sunlamps and tanning beds.

Skin reactions such as dryness, redness, peeling, burning, or itching can occur when you use this medicine. Use a moisturizer as needed to lessen these skin problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

If you have a sunburn, stop using this medicine until your skin is healed.

Do not use any other medicines on the treated skin areas without talking to your doctor. Avoid using any skin care products that can dry or irritate your skin. These include rough skin cleansers, wart removal products, soaps or cosmetics that cause dryness, or products that contain alcohol, astringents, spices, or lime.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Redness, peeling, drying, itching, or burning of the skin

Less common

Darkening of normal skin color

irritated skin

rash

Incidence not known

Blistering, crusting, or flaking of the skin

burning and itching of the skin with pinhead-sized red blisters

lightening of normal skin color

redness and scaling around the mouth

severe redness, soreness, or scaling of the skin

thinning of the skin with easy bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Blemishes on the skin

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

pimples

raised, dark red, wart-like spots on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.