tri-luma
Tri-Luma is a combination medicine containing Fluocinolone Acetonide, Hydroquinone, and Tretinoin.
Fluocinolone Acetonide and Hydroquinone and Tretinoin · by Galderma Labs LP
Key facts
- Active ingredient
- Fluocinolone Acetonide and Hydroquinone and Tretinoin
- Form
- Topical
- Strength
- Fluocinolone Acetonide 0.01%; Hydroquinone 4%; Tretinoin 0.05%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Galderma Labs LP
- FDA application
- NDA021112
What is Tri-Luma?
From the FDA label: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-3,20-dione. The molecular formula is C 24 H 30 F 2 O 6 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 C 6 H 6 O 2 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…
How to use
Apply a thin film of TRI-LUMA Cream to the effected area once daily, at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply TRI-LUMA Cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. Therapy should be discontinued when control is achieved. During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. TRI-LUMA Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected area once daily, at least 30 minutes before bedtime. ( 2 ) During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. ( 2 )
Side effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the controlled clinical trials, adverse events were monitored in the 161 subjects who used TRI-LUMA Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity. Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with TRI-LUMA Cream from the controlled clinical trials are summarized (in decreasing order of frequency) as follows: Table 1. Incidence and Frequency of Treatment-related Adverse Events with TRI-LUMA Cream in at least 1% or more of Subjects (N=161) Adverse Event n (%) Erythema 66 (41%) Desquamation 61 (38%) Burning 29 (18%) Dryness 23 (14%) Pruritus 18 (11%) Acne 8 (5%) Paresthesia 5 (3%) Telangiectasia 5 (3%) Hyperesthesia 3 (2%) Pigmentary changes 3 (2%) Irritation 3 (2%) Papules 2 (1%) Acne-like rash 1 (1%) Rosacea 1 (1%) Dry Mouth 1 (1%)…
Warnings
Important safety information
Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. If anaphylaxis, asthma or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue TRI-LUMA. ( 5.1 ) TRI-LUMA Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. ( 5.2 ) 5.1 Hypersensitivity TRI-LUMA Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. If anaphylaxis, asthma or other clinically significant hypersensitivity reactions occur, institute appropriate therapy and discontinue TRI-LUMA. Allergic contact dermatitis may also occur [ see Warnings and Precautions 5.4 ]. 5.2 Exogenous Ochronosis TRI-LUMA Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics. 5.3 Effects on Endocrine System TRI-LUMA Cream contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of TRI-LUMA Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids. The ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression. 5.4 Cutaneous Reactions Cutaneous hypersensitivity to the active ingredients of TRI-LUMA Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to TRI-LUMA Cream or its components. TRI-LUMA Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on TRI-LUMA Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Who should not take Tri-Luma
Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components. TRI-LUMA Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components. ( 4 )
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- Is there a coupon or discount for Tri-Luma?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tri-Luma. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tri-Luma?
- Tri-Luma is marketed by Galderma Labs LP. You can see Galderma Labs LP's full profile, rating, and other products on pharmaranks.
- Is Tri-Luma a brand-name or generic drug?
- Tri-Luma is a brand-name product with the active ingredient Fluocinolone Acetonide and Hydroquinone and Tretinoin.
- Is Tri-Luma available over the counter?
- No. Tri-Luma is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tri-Luma come in?
- Tri-Luma is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Tri-Luma FDA-registered?
- Tri-Luma is on record with the U.S. FDA under application number NDA021112. You can verify this on its official FDA label.
- Is Tri-Luma safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Tri-Luma. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Tri-Luma?
- Tri-Luma's side effects are taken directly from its FDA label. From the label: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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