"The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
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(fluocinolone acetonide, hydroquinone, and tretinoin) Cream for Topical Application
TRI-LUMA (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application.
Fluocinolone acetonide is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light.
The chemical name for fluocinolone acetonide is: (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20dione.
The molecular formula is C24H30F2O6 and molecular weight is 452.50.
Fluocinolone acetonide has the following structural formula:
Hydroquinone is a melanin synthesis inhibitor. 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, a retinoid, 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.
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-LUMA 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 anhydrous, 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 serious side effects may include:
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 to vitamin A-related drugs (other retinoids such as isotretinoin); 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...
Last reviewed on RxList: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.
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