Fluocinolone Acetonide, Hydroquinone, And Tretinoin
FDA Drug Information • Also known as: Tri-Luma
- Brand Names
- Tri-Luma
- Drug Class
- Corticosteroid [EPC], Melanin Synthesis Inhibitor [EPC], Retinoid [EPC]
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 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 )-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. The molecular formula is C 20 H 28 O 2 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. fluocinolone-mol...
What Is Fluocinolone Acetonide, Hydroquinone, And Tretinoin Used For?
1 INDICATIONS AND USAGE TRI-LUMA Cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. ( 1 ) 1.1 Indication TRI-LUMA Cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. 1.2 Limitations of Use TRI-LUMA Cream is NOT indicated for the maintenance treatment of melasma. After achieving control with TRI-LUMA Cream, some patients may be managed with other treatments instead of triple therapy with TRI-LUMA Cream. Melasma usually recurs upon discontinuation of TRI-LUMA Cream. The safety and efficacy of TRI-LUMA Cream in patients of Fitzpatrick Skin Types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded. The safety and efficacy of TRI-LUMA Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied. Because pregnant and lactating women were excluded from, and women of childbearing potential had to use birth control measures in the clinical trials, the safety and efficacy of TRI-LUMA Cream in pregnant women and nursing mothers have not been established [ see Use in Specific Populations (8.1, 8.3 )].
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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 (Adverse Reactions)
6 ADVERSE REACTIONS 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%) Rash 1 (1%) Vesicles 1 (1%) In an open-label trial, subjects who had cumulative treatment of melasma with TRI-LUMA Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies. The following local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Most common adverse reactions (incidence > 5%) are erythema, desquamation, burning, dryness, pruritus, and acne. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contraindications
4 CONTRAINDICATIONS 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 )
Pregnancy and Breastfeeding
8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. TRI-LUMA Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. TRI-LUMA Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. In clinical trials involving TRI-LUMA Cream in the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 13 women became pregnant during treatment with TRI-LUMA Cream. Most of the pregnancy outcomes are unknown. Three women gave birth to apparently healthy babies. One pregnancy was terminated prematurely, and another ended in miscarriage. In general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to TRI-LUMA Cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. The risk of teratogenesis due to topical exposure to TRI-LUMA Cream may be considered low. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy. Tretinoin is considered to be highly teratogenic upon systemic administration. Animal reproductive studies are not available with topical hydroquinone. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
8.3 Nursing Mothers Corticosteroids, when systemically administered, appear in human milk. It is not known whether topical application of TRI-LUMA Cream could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when TRI-LUMA Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and TRI-LUMA Cream.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING TRI-LUMA Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30. Storage: Keep tightly closed. Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.