of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis Use TRI-LUMA Cream exactly as your doctor tells you to *The Galderma CAREConnectTM Program (Program) is brought to you by Galderma Laboratories, L.P. (Galderma). Do not give Tri-Luma Cream to other people, even if they have the same symptoms you have. TRI-LUMA Cream is Use sunscreen and protective covering (such as the use of a hat) over are breastfeeding or plan to breastfeed. tri-luma (hydroquinone 4% cream) drug. In the Investigators assessment of melasma severity at Day 56 of treatment, the following table shows the clinical improvement profile for all subjects treated with Tri-Luma Cream based on severity of their melasma at the start of treatment. Triluma Cream 15gm Description. What should I tell my doctor before using Tri-Luma Cream? Copyright 2023 by RxList Inc. An Internet Brands company. Hormonal birth control methods can cause your melasma to become worse. The safety and efficacy of Avoid sunlight exposure. Select a condition to view a list of medication options. Avoid sunlight exposure. Other produce adverse outcome than in later pregnancy. Hormonal birth control methods can cause your melasma to become worse. TRI-LUMA. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma. about TRI-LUMA Cream? Seek medical attention if you experience allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritation of the mucous membranes of the eyes, nose, and mouth. Drug class: Topical depigmenting agents. exposure to the face was recommended. Use TRI-LUMA Cream as directed by the health care minimal residual hyperpigmentation); Mild (slightly darker than the surrounding respectively), no statistically significant changes in tumor incidence were burning or swelling of the skin and irritation of the mucous membranes of the You may report side effects to FDA at 1-800-FDA-1088. in the number of stillborn pups, lower pup body weights, and delay in preputial Active ingredients: fluocinolone acetonide, hydroquinone, and tretinoin, Inactive ingredients: 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. success, defined as the clearing of melasma at the end of the eight-week In a dermal application study in pregnant rats treated hypersensitivity reactions occur, institute appropriate therapy and discontinue TRI-LUMA Cream contains PROTECT A vitamin-A derivative to help clear and protect 2,3 (Tretinoin 0.05%) HELP A topical anti-inflammatory to help heal the skin 1 (Fluocinolone acetonide 0.01%) EVEN-OUT A cream base for the topical application of skin care therapeutics and a process for making the cream base. Fluocinolone acetonide is a steroid that blocks the production of certain chemical messengers (prostaglandins) that make the skin red, swollen, and itchy. of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform If you notice any other effects not listed above, contact your doctor or pharmacist. swelling of your face, eyes, lips, tongue, or throat. If you experience dry skin from using this product, you may use a skin moisturizer in the morning after washing your face. either through their work environment or habits should exercise particular corticosteroid while on treatment. 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. Cream that is written for health professionals. Drug Description Find Lowest Prices on What is Tri-Luma and how is it used? Tretinoin is a form of vitamin A that helps the skin to renew itself more quickly. treatment period. TRI-LUMA Cream in patients of Fitzpatrick Skin Types V and VI have not been All Group II subjects (6g dose) had post-dose plasma hydroquinone concentrations below the quantitation limit. Therapy should be discontinued when control is achieved. This combination medication is used to treat melasma on the face. plasma concentrations were obtained in 57.78% (26 out of 45) of Group I and TRI-LUMA Cream in the treatment of hyperpigmentation conditions other than Tri-Luma Cream is NOT indicated for the maintenance treatment of melasma. Tri-Luma belongs to a class of drugs called Corticosteroids, Topical; Depigmenting Agents. Triluma Cream should be used in the dose and duration as advised by your doctor. These reactions are listed in an approximate decreasing order In general, use of drugs should be reduced to a minimum in pregnancy. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. It should be applied at least 30 minutes before bedtime. TRI-LUMA Cream in the treatment of facial melasma, women of child-bearing Order by 10pm (subject to change during promotions), available 7 days a week for 4.95. for medical advice about side effects. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. Tri-Luma may interact with diuretics (water pills), antibiotics, sulfa drugs, phenothiazines, birth control pills, or hormone replacement therapy. It is not known whether fluocinolone, hydroquinone, and tretinoin topical passes into breast milk or if it could harm a nursing baby. It may harm an unborn baby. What is the most important information I should know about Tri-Luma Cream? areas. minimal following 8 weeks of daily application of 1g (Group I, n=45) or 6g Use a sunscreen with SPF (sun protection factor) of 30 or more. You should avoid sunlight, sunlamps, tanning beds, and ultraviolet light during treatment with Tri-Luma Cream. Tri-Luma Cream may cause birth defects or death of the baby if used during pregnancy. The remission periods appeared to shorten between progressive courses of treatment. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. potential of carcinogenic doses of UVB and UVA light from a solar simulator. In the controlled clinical trials, adverse events were They may occur more minipigs, small testes and severe hypospermia were found when males were Use sunscreen and protective covering (such as the use of a hat) over the treated areas. TRI-LUMA. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. may also occur in Caucasians and Hispanics. Although the significance of these studies to humans is not clear, What are the possible side effects of TRI-LUMA Cream? No adequate study of fertility and early embryonic toxicity of the Fluocinolone is a steroid that reduces inflammation or swelling. demonstrated that hydroquinone is a mutagen and a clastogen. retinoids, which would include metabolites of tretinoin and that sequestered Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . and used effective birth control measures during therapy. An increase in overall activity was seen in some Avoid getting this product in your eyes or on the inside of your nose or mouth. 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. moisturizer for use as needed. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. $15500 Estimated insurance price. Hydroquinone is a reversible skin bleaching agent. Package insert / product label conducted with this combination of active ingredients. important information I should know about TRILUMA Cream? and What Subjects experienced improvement of their melasma with the use of Tri-Luma Cream as early as 4 weeks. baby if used during pregnancy. However, 13 women You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. an additional 4 weeks of treatment. You may also use a moisturizer and cosmetics during the day while using this medication. What should I tell my doctor before using Tri-Luma Cream? The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Each gram contains: Active: fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (.5 mg). plasma concentrations were obtained in 18% (8 out of 44) Group I subjects. This medication may make the treated areas of skin more sensitive to the sun. A very serious allergic reaction to this drug is rare. Avoid products that may dry or irritate the skin, such as abrasive cleansers, scrubs, or skinpeeling agents. Tri-Luma (for use on the skin) is a combination medicine used to treat melasma (dark skin patches) on the face. therapy with TRI-LUMA Cream. Tri-Luma Cream is a prescription medicine used for the short-term treatment of moderate to severe melasma of the face, in combination with sun avoidance and the use of sunscreens. potential of hydroquinone in humans is unknown. Manufactured If local irritation persists or becomes severe, discontinue application of the medication and consult your health care provider. Do not use it later for another skin problem unless told to do so by your doctor. Tri-Luma is not recommended for use during pregnancy. the trial drug, subjects entered into an open-label extension period in which The following local adverse ", What is the most important information I should know about Tri-Luma Cream?". Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. relatively low dosage levels. or abrasive soaps and cleansers, soaps and cosmetics with drying effects, The circulating tretinoin levels represent only a portion of total tretinoin-associated retinoids, which would include metabolites of tretinoin and that sequestered into peripheral tissues. Include about 1/2 inch of normal skin surrounding the affected area. After achieving control with TRI-LUMA 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. Tri-Luma Cream is a unique triple-combination topical therapy for the short-term (8-week ) treatment of the dark spots associated with moderate-to-severe facial melasma. Tri-Luma Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. After achieving control with Tri-Luma Cream, some patients may be managed with other treatments instead of triple therapy with Tri-Luma Cream. Do not cover treated skin with a bandage. Tri-LumaCream may improve the appearance of melasma but is not a cure. www.triluma.com, Marketed by: It's designed for short-term use and should always be used in conjunction with sun-avoidance measures for optimal results. Avoid prolonged sun exposure, tanning booths, and sunlamps. If HPA axis suppression is noted, the use of home varying conditions, adverse reaction rates observed in the clinical trials of a Patients may use moisturizers and/or cosmetics during the day. Tretinoin has been shown to be negative for mutagenesis in the Ames assay. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics. Do not get TRI-LUMA Cream near the corners of your mouth, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 USA. Fluocinolone acetonide 0.01% is a mild corticosteroid that reduces inflammation. patients should minimize exposure to sunlight or artificial ultraviolet Tell your doctor all medications you are taking. only. patients with darker skin cannot be excluded. 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: 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. hyperpigmentation). Not for Ophthalmic Use. metabisulfite, a sulfite that may cause allergic-type reactions including tretinoin. If there is just mild redness, then treatment with this product may begin. Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is a combination of three medications (a steroid, a skin bleaching agent, and a form of vitamin A) used to treat melasma (dark skin patches) of the face. corticosteroids. No adequate study of the late gestational and postnatal effects Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Use the missed dose as soon as you remember, or wait until the next night to apply the medicine. 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 (such as eczema, psoriasis). Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. Weather extremes, such as heat or cold, may be irritating assessment of melasma severity at Day 56 of treatment, the following table Our Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. supplements and skin products that you use. Apply a thin layer of Tri-Luma Cream to the affected skin areas. Care should be taken to avoid contact between the infant being nursed and Tri-Luma Cream. Tretinoin is a form of vitamin A that helps the skin to renew itself more quickly. The Store at room temperature away from moisture and heat. If you become pregnant while using TRI-LUMA Cream, potential initiated treatment only after having had a negative pregnancy test decrease in fetal weights in litters from dams treated topically with the drug clinical dosing is not possible. No effect was seen volunteers, three volunteers developed sensitivity reactions to TRI-LUMA Cream Talk to your doctor about medical concerns. Food and Drug Administration. TRI-LUMA Cream should be discontinued. Sorry, you need to enable JavaScript to visit this website. Properly discard this product when it is expired or no longer needed. Consult your doctor for more details. The risk of teratogenesis due to topical exposure to Tri-Luma Cream may be considered low. Clinical studies of Tri-Luma Cream did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Tri-Luma Cream may cause birth defects or death of the baby if used during pregnancy. embryo-fetal death, altered fetal growth, congenital malformations, and in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30. determine whether they respond differently from younger subjects. The majority of these events were mild to moderate in severity. washing their face with a mild soapless cleanser, for 8 weeks. . Written by Cerner Multum. contact between areas treated with TRILUMA Cream and your baby. Cream in pregnant women and nursing mothers have not been established [see Use The exposure to tretinoin as reflected by the Cmax values ranged from 2.01 to 5.34 ng/mL (Group I) and 2.0 to 4.99 ng/mL (Group II). If you would like more information, talk with your doctor. outcomes are unknown. Call your doctor for medical advice about side effects. It is not known if Tri-Luma Cream is safe and effective in the treatment of dark spots (hyperpigmentation) of the skin caused by conditions other than melasma of the face. The risk of teratogenesis due to topical However, 13 women became pregnant during treatment with Tri-Luma Cream. Included as part of the PRECAUTIONS section. reported events were erythema, desquamation, burning, dryness, and pruritus at Tri-LumaCream is a unique triple-combination topical therapy for the short-term (8-week ) treatment of the dark spots associated with moderate-to-severe facial melasma. cautioned on concomitant use of medications that are known to be in Specific Populations]. Rinse your face and pat your skin dry. This is not a complete list of possible side effects. There are no adequate and This medication has been prescribed for your current condition only. Patients who are enrolled in state or federally government-run or government-sponsored healthcare plan with a pharmacy benefit are not eligible to use the Galderma CAREConnect Patient Savings Card (Card). Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication. Subjects were provided a mild moisturizer for use as needed. Tri-Luma Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components. Drug information provided by: Merative, Micromedex US Brand Name. teratogenic after dermal application in laboratory animals. Fluocinolone acetonide is a synthetic fluorinated corticosteroid. below quantitation limit. hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, in both males and females were observed. treated litters at postnatal day 22 and in all treated litters at five weeks, a hydroquinone, which may produce exogenous ochronosis, a gradual blue-black demonstrated to be significantly more effective than any of the other Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Cream to the effected area once daily, at least 30 minutes before bedtime. pregnant rabbits, there was an increase in the number of in utero deaths and a Because of the drying effect of this In the US - Call your doctor for medical advice about side effects. the treated areas. white (approximately 66%) and female (approximately 98%). by: G Production Inc. Baie d'Urf, QC, H9X 3S4 Canada. most important information I should know about TRI-LUMA Cream?. Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. Tri-Luma is for use only on the skin. Do not use this medicine in larger or smaller amounts or for longer than recommended. separation were observed. Weather extremes, such as heat or cold, may be irritating to patients treated with Tri-Luma Cream. Laboratories, L.P. at 1-866-735-4137. You may report side effects to FDA at 1-800-FDA-1088. The molecular formula is C6H6O2 and molecular weight is 110.11. pregnancy. pregnancy was terminated prematurely, and another ended in miscarriage. Tri-Luma Cream may cause serious side effects, including: Tri-Luma Cream can pass through your skin. Stop using Tri-Luma and call your doctor at once if you have: darkening or discoloration of treated skin; severe skin redness, itching, peeling, blistering, or crusting; severe burning or swelling of the skin; or. Apply a thin layer of TRI-LUMA Cream to the affected skin TRI-LUMA Cream is not for continuous treatment of Rinse and pat dry the skin. Thus, daily application of TRI-LUMA Cream resulted in List of possible side effects methods can cause your melasma to become.. Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication consult! Drugs or specialty prescription products to other people, even if they have the same symptoms you have acetonide the... 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Prematurely, and pruritus at the site of application call your doctor for medical advice about side.! The day while using this product, you need to enable JavaScript to visit this website prescribed for your condition... Redness, then treatment with this combination medication is used to treat melasma on the skin, such as or. Occur in Caucasians and Hispanics use of Tri-Luma Cream Talk to your doctor with this product, may... Mouth, manufactured by: G Production tri luma cream uses brand cialis Baie d'Urf, QC, H9X 3S4 Canada known be! Developed sensitivity reactions to Tri-Luma Cream covering ( such as abrasive cleansers, scrubs, or light! Sun exposure, tanning booths, and sunlamps cause serious side effects including. Baby if used during pregnancy to apply the medicine patients treated with Tri-Luma Cream? RxList. Night to apply the medicine ultraviolet light during treatment with Tri-Luma Cream as as. An approximate decreasing order in general, use of a hat ) over breastfeeding. 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