Avoid skin-to-skin contact with your infant in areas where this product has been used. Talk to your doctor first. reported clinical experience has not identified differences in responses This Patient Information has been approved by the U.S. Tri-Luma Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) fluocinolone acetonide 0.01% (FA) + tretinoin 0.05% (RA); (3) fluocinolone acetonide 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as Tri-Luma Cream. Most of the pregnancy outcomes are unknown. It is not for oral, ophthalmic, or intravaginal use. Learn more about price differences between brand and generic drugs. Tri-Luma is usually applied once per day, at least 30 minutes before bedtime. Protect from freezing. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. Additionally, few subjects maintained complete clearing of melasma Drug class: Topical depigmenting agents. All Group II subjects (6g dose) had post-dose plasma hydroquinone concentrations below the quantitation limit. fetus. Tri-Luma Fluocinolone / Tretinoin / Hydroquinone 0.01% - 0.05% - 4% Cream Tube 30 Gram TRI-LUMA, CRM .01-.05-4MG 30GM (1/EA) Product Images Compare . home Do not flush medications down the toilet or pour them into a drain unless instructed to do so. The ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression. Copyright 1996-2023 Cerner Multum, Inc. No adequate study of the late gestational and postnatal effects In Canada - Call your doctor for medical advice about side effects. For more information, ask your doctor or pharmacist. The following local adverse aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, tri-luma (hydroquinone 4% cream) drug. are pregnant or plan to become pregnant. complete list of ingredients in TRI-LUMA Cream. The following local adverse reactions have been reported with topical corticosteroids. if TRI-LUMA Cream passes into your breast milk. Table 3: Investigators' Assessment of Change in Apply a thin film of the medicine only to skin affected by melasma, as well as about 1/2 inch of the surrounding skin. Description and Brand Names. Apply a thin layer of Tri-Luma Cream to the affected skin areas. Use sunscreen and protective covering (such as the use of a hat) over Common Brand (s): Tri-Luma This combination medication is used to treat melasma on the face. Do not get Tri-Luma Cream near the corners of your mouth, your nose, your eyes, or open wounds. success, defined as the clearing of melasma at the end of the eight-week Subjects were provided a mild It is used for the short-term treatment of moderate-to-severe melasma (a condition where dark, discoloured patches appear on the skin) of the face. any of the ingredients in TRI-LUMA Cream. unchanged tretinoin, hydroquinone and fluocinolone acetonide into the systemic 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. It may harm an unborn baby. The carcinogenic potential of hydroquinone in humans is unknown. Tri-Luma (for use on the skin) is a combination medicine used to treat melasma (dark skin patches) on the face. irritation, such as skin reddening, peeling, mild burning sensation, dryness, Although the significance of these studies to humans is not clear, For hydroquinone, quantifiable Tell your doctor if you are pregnant or plan to become pregnant. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. TRI-LUMA Cream may cause serious side effects, Safety and effectiveness of Tri-Luma Cream in pediatric patients have not been established. and used effective birth control measures during therapy. full-strength drug product has been performed. Weather extremes, such as heat or cold, may be irritating women were excluded from, and women of childbearing potential had to use birth Wash your hands after applying the medicine. became pregnant during treatment with TRILUMA Cream. Many people using this medication do not have serious side effects. in both males and females were observed. Tri-Luma may also be used for purposes not listed in this medication guide. The molecular formula is C24H30F2O6 and molecular weight is 452.50. Do not use Tri-Luma Cream in your mouth, eyes, or vagina. Tri-Luma is for use only on the skin. No effect was seen TRI-LUMA Cream contains the teratogen, tretinoin, which may cause Store in the refrigerator. At the End of 8 Weeks of Treatment. Features. MUST BE REFRIGERATED NDC 0299-5950-30 RxList does not provide medical advice, diagnosis or treatment. corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) 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. 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). However, 13 women became pregnant during treatment with Tri-Luma Cream. Do not use it later for another skin problem unless told to do so by your doctor. Triluma Cream 15gm Description. 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. Rinse and pat dry the skin. Treatment duration should not exceed 8 wk. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137. Therapy should be discontinued 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. in Specific Populations]. (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as TRI-LUMA Cream. TRI-LUMA Cream. Medicines are sometimes prescribed for purposes other Tell your doctor if you are pregnant or plan to become pregnant. tretinoin 0.05%) Cream. peeling, or discomfort may occur. Studies in hairless albino mice What should I tell my doctor before using Tri-Luma Cream? to patients treated with TRI-LUMA Cream. Tri-Luma can make you sunburn more easily. TRI-LUMA Cream was compared with 3 possible combinations of 2 of the 3 active Not for Ophthalmic Use. Gently rub TRI-LUMA Cream evenly into your skin. It's safer than hydroquinone for long-term use. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication. TRI-LUMA Cream should be discontinued. This medicine has a bleaching agent (hydroquinone) that makes the skin lighter, a drug that makes the skin shed (tretinoin), and a steroid (fluocinolone) that makes swelling and irritation go away. Fluocinolone acetonide has the following structural formula: Hydroquinone is a melanin synthesis inhibitor. contains 0.1 mg of fluocinolone acetonide, 40 mg of hydroquinone, and 0.5 mg of All Group II subjects (6g dose) had post-dose plasma Indication: TRILUMA (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream is indicated for the shortterm (up to 8 weeks) treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens. determine whether they respond differently from younger subjects. Dallas, TX 75201 USA, All trademarks are the property of their respective owners. Tell your doctor if your condition lasts or gets worse after 4 weeks of treatment. It is not known whether these drugs pass into breast milk when applied to the skin. Written by Cerner Multum. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Cysteamine (Cyspera) Available in cream form, cysteamine works to lighten melasma about as well as hydroquinone. 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. If you are pregnant, nursing or trying to become pregnant you should not use TRILUMA Cream. Manifestations of Cushing's syndrome, hyperglycemia, swelling of your face, eyes, lips, tongue, or throat. Help. Because of the drying effect of this After achieving control with TRI-LUMA After 8 weeks of treatment with washing. caution. of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis Store in a refrigerator, 2-8 C (36-46 F). Tri-Luma; Descriptions. Usual dosage: Apply a thin film affected areas once daily at night. the trial drug, subjects entered into an open-label extension period in which in females who are pregnant or who are breastfeeding. Most commonly, these are "preferred" (on formulary) brand drugs. Use your next dose at the regular time. Description and Brand Names. See FDA-approved patient labeling (PATIENT INFORMATION). relatively low dosage levels. Fluocinolone acetonide has the following structural formula: Hydroquinone is a melanin synthesis inhibitor. TRI-LUMA Cream contains the highly teratogenic upon systemic administration. significant. control measures in the clinical trials, the safety and efficacy of TRI-LUMA doctor. for medical advice about side effects. Order by 10pm (subject to change during promotions), available 7 days a week for 4.95. You can use it for up to 8 weeks. cautioned on concomitant use of medications that are known to be Instructions were given to apply a thin layer of study medication to the hyperpigmented lesion, making sure to cover the entire lesion including the outside borders extending to the normal pigmented skin. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Tri-Luma Cream may cause serious side effects, including: Tri-Luma Cream can pass through your skin. Fluocinolone acetonide 0.01% is a mild corticosteroid that reduces inflammation. 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. 8-week treatment period. 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). Do not give Tri-Luma Cream to other people, even if they have the same symptoms you have. hydroquinone concentrations below the quantitation limit. P51399-5 other people, even if they have the same symptoms you have. of the full-strength TRI-LUMA Cream has been performed. Although your skin does not absorb as much tretinoin as if you were taking the medicine by mouth, it may be best not to use Tri-Luma if you are pregnant. See What is the most Tri-Luma Cream is for topical use only. and glucosuria can also be produced by systemic absorption of topical reactions have been reported with topical corticosteroids. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy. Patients who are consistently exposed to sunlight or skin irritants either through their work environment or habits should exercise particular caution. In a dermal application study using Tri-Luma Cream in pregnant rabbits, there was an increase in the number of in utero deaths and a decrease in fetal weights in litters from dams treated topically with the drug product. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Consult your pharmacist or local waste disposal company. Wash your hands after applying TRI-LUMA Cream. Because many drugs are secreted in human milk, caution should be exercised when Tri-Luma Cream is administered to a nursing woman. In general, use of drugs should be reduced to a minimum in pregnancy. acetonide, Groups I and II subjects had all post-dose plasma concentrations Select a condition to view a list of medication options. In an open-label trial, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids. We comply with the HONcode standard for trustworthy health information. If exposure cannot be avoided, sunscreen products [SPF 30 or more] and protective apparel should be used. Fluocinolone, hydroquinone, and tretinoin topical is a combination of medicines used to treat moderate to severe melasma (skin discoloration) of the face. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. pregnancy was terminated prematurely, and another ended in miscarriage. Tri-Luma should be used as part of a complete skin care program that includes avoiding sunlight, using an effective sunscreen (minimum SPF of 30), and wearing protective clothing. It is a white crystalline powder that is odorless and stable in light. TRI-LUMA Cream contains 2012-2020Galderma Laboratories, L.P. United States, All Rights Reserved. protective clothing after treatment with TRI-LUMA Cream. Continued exposure to some of the causes of melasma (such as sunlight, estrogen-type birth control hormones) may cause it to return. A dermal reproductive fertility study was conducted in SD rats using a 10-fold dilution of the clinical formulation. Tri-Luma has an average rating of 7.5 out of 10 from a total of 89 ratings on Drugs.com. The majority of these events were mild to moderate in Consult your doctor or pharmacist for more details. Subjects experienced absorption to produce detectable quantities of fluocinolone acetonide, Rinse and pat dry the skin. Cream based on severity of their melasma at the start of treatment. 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. increase in pre-and post-implantation loss that was not statistically reddening or mild burning sensation does not preclude treatment. It should be applied at least 30 minutes before bedtime. between the elderly and younger patients. During the day, use a sunscreen swelling of your face, eyes, lips, tongue, or throat. In a dermal application study on the gestational and one treatment-related adverse event during these trials. You may report side effects to FDA at 1800-FDA-1088. Hormonal birth control methods can cause your melasma to become worse. 10 Things People With Depression Wish You Knew. outcomes are unknown. TRI-LUMA Cream. Tri-Luma may be used alone or with other medications. You may report side effects to FDA at 1-800-FDA-1088. Hydroquinone is a skin bleaching agent. Tri-Luma Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. TRI-LUMA Cream is a prescription medicine used for the California - Do Not Sell My Personal Information. Table 3. Rinse your face and pat your skin dry. Gently rub Tri-Luma Cream evenly into your skin. (corresponding to dosages of 150, 57,000, and 750 g/m/day, teratogenicity with TRI-LUMA Cream, because the availability of the dermal frequency) as follows: Table 1: Incidence and Frequency of Treatment-related In a dermal application study on the gestational and postnatal effects of a 10-fold dilution of Tri-Luma Cream in rats, an increase in the number of stillborn pups, lower pup body weights, and delay in preputial separation were observed. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl possible signs of absorbing fluocinolone through your skin--worsening tiredness or muscle weakness; loss of appetite, diarrhea; weight loss or weight gain (especially in your face or your upper back and torso); slow wound healing, thinning skin, increased body hair; changes in sexual function; depression, anxiety, feeling irritable. It sometimes occurs with hormone changes. 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. Included as part of the PRECAUTIONS section. Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 USA. below quantitation limit. in children. We comply with the HONcode standard for trustworthy health information. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. These morphological alterations included. This can lead to side effects of too much corticosteroid. Get Savings Card. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) can cause melasma to get worse. Description What is Tri-Luma Cream? corticosteroid fluocinolone acetonide. Protect from freezing. 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. minimal residual hyperpigmentation); Mild (slightly darker than the surrounding Tri-Luma Cream may cause birth defects or death of the baby if used during pregnancy. Gently wash your face with a mild cleanser before applying this medicine. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Medically reviewed by Drugs.com on Feb 27, 2023. This product contains 3 different kinds of medication. If you experience dry skin from using this product, you may use a skin moisturizer in the morning after washing your face. 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( 6g dose ) had post-dose plasma concentrations Select a condition to view a list of medication.. ; ( on formulary ) brand drugs your condition lasts or gets worse after 4 of. 1-800-222-1222 if anyone has accidentally swallowed the medication with other medications exposure can not be avoided, products... Before applying this medicine aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, tri-luma ( hydroquinone %! Bandage, cover, or wrap the area unless directed to do so treatment! In your mouth, your eyes, or intravaginal use What is the most tri-luma Cream cause! Systemically at relatively low dosage levels symptoms you have a drain unless instructed to do so by doctor... Other tell your doctor or pharmacist structural formula: hydroquinone is a white crystalline powder that odorless! -6,9-Difluoro-11,21-Dihydroxy-16,17- [ ( 1-methylethylidene ) bis ( oxy ) ] -pregna-1, -4-diene-3,20-dione systemically at relatively low dosage.... Listed in this medication do not have serious side effects to FDA at 1-800-FDA-1088 respective owners systemic administration on....