Tri-Luma

DRUG DESCRIPTION

TRI-LUMAź (hydroquinone 4% cream) Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a hydrophilic cream base for topical application.

Fluocinolone acetonide is a synthetic fluorinated corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. It is a white crystalline powder that is odorless and stable in light.

The chemical name for fluocinolone acetonide is: (6 ,11 ,16 )-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.

The molecular formula is C24H30F2O6 and molecular weight is 452.50. Fluocinolone acetonide has the following structural formula:

Fluocinolone acetonide Structural Formula Illustration

Hydroquinone is classified therapeutically as a depigmenting agent. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air.

The chemical name for hydroquinone is: 1,4-benzenediol.

The molecular formula is C6H6O2 and molecular weight is 110.11.

Hydroquinone has the following structural formula:

Tretinoin is all-trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture. Tretinoin is classified therapeutically as a keratolytic.

The chemical name for tretinoin is: (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.

The molecular formula is C20H28O2 and molecular weight is 300.44.

Tretinoin has the following structural formula:

Each gram of TRI-LUMAź (hydroquinone 4% cream) Cream contains Active: fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive: 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.

What are the possible side effects of fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor if you have any of these serious side effects:

  • darkening of the treated skin;
  • severe skin irritation, blistering, oozing, scaling, or crusting;
  • severe burning or swelling of the skin; or
  • irritation of your eyes, nose, or mouth.

Less...

Read All Potential Side Effects and See Pictures of Tri-Luma »

What are the precautions when taking hydroquinone 4% cream (Tri-Luma)?

Before using fluocinolone/tretinoin/hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (e.g., eczema, psoriasis).

Too much bleaching of the skin might occur in some cases, resulting in an undesirable cosmetic effect in those with darker skin. Consult your doctor or pharmacist for more...

Read All Potential Precautions of Tri-Luma »


Tri-Luma Consumer (continued)

SIDE EFFECTS: See also How to Use.

Mild burning, stinging, redness, dryness, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), "hair bumps" (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time or over large areas of the skin. Tell your doctor immediately if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluocinolone/tretinoin/hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (e.g., eczema, psoriasis).

Too much bleaching of the skin might occur in some cases, resulting in an undesirable cosmetic effect in those with darker skin. Consult your doctor or pharmacist for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Children may be more sensitive to the effects of too much corticosteroid medication. Though it is very unlikely to occur with corticosteroids applied to the skin, this medication may temporarily slow down a child's rate of growth if used for long periods. However, it will probably not affect final adult height. Monitor your child's height periodically.

This medication is not recommended for use during pregnancy. One medication in this product (tretinoin) has caused harm to an unborn baby when taken by mouth. Discuss the risks and benefits with your doctor.

It is not known whether these drugs pass into breast milk when applied to the skin. Consult your doctor before breast-feeding. Avoid skin-to-skin contact with your infant in areas where this product has been used.


Tri-Luma Patient Information Including Side Effects

Brand Names: Tri-Luma

Generic Name: fluocinolone, hydroquinone, and tretinoin topical (Pronunciation: FLOO oh SIN oh lone, HYE droe KWIN one, TRET in oin)

  • What is fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • What are the possible side effects of fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • What is the most important information I should know about fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • What should I discuss with my healthcare provider before using fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • How should I use fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • What happens if I miss a dose (Tri-Luma)?
  • What happens if I overdose (Tri-Luma)?
  • What should I avoid while using fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • What other drugs will affect fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?
  • Where can I get more information?

What is fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?

Fluocinolone is a steroid. It reduces inflammation or swelling.

Hydroquinone topical is a skin bleaching agent.

Tretinoin topical is a form of vitamin A. It helps the skin to renew itself more quickly.

The combination of fluocinolone, hydroquinone, and tretinoin topical is used to treat melasma (dark skin patches) of the face.

Fluocinolone, hydroquinone, and tretinoin topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor if you have any of these serious side effects:

  • darkening of the treated skin;
  • severe skin irritation, blistering, oozing, scaling, or crusting;
  • severe burning or swelling of the skin; or
  • irritation of your eyes, nose, or mouth.

Less serious side effects may include:

  • mild redness, burning, stinging, tingling, itching, swelling, dryness, or peeling of your skin;
  • rash;
  • acne;
  • skin bumps or blisters; or
  • more noticeable red lines or blood vessels showing through your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluocinolone, hydroquinone, and tretinoin topical (Tri-Luma)?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). This medication can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid getting this medication in your mouth, eyes, or nose, and avoid applying it to your lips or in the creases of your nose. If it does get into any of these areas, rinse with water. Do not use the medication on sunburned, windburned, dry, chapped, irritated, or broken skin. Wait until these areas have healed.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

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