Fluocinolone Acetonide, Hydroquinone, And Tretinoin (Tri-Luma)

Trade Name : TRI-LUMA

Galderma Laboratories, L.P.

CREAM

Strength .140.5 mg/gmg/gmg/g

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Retinoid [EPC],Retinoids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluocinolone Acetonide, Hydroquinone, And Tretinoin (Tri-Luma) which is also known as TRI-LUMA and Manufactured by Galderma Laboratories, L.P.. It is available in strength of .1; 40; .5 mg/g; mg/g; mg/g per ml. Read more

Fluocinolone Acetonide, Hydroquinone, And Tretinoin (Tri-Luma) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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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. ()

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. ()
During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. ()

Cream, 0.01%/4%/0.05%.
Each gram of TRI-LUMA Cream contains 0.1 mg of fluocinolone acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin in a light yellow, hydrophilic cream base.

Cream, 0.01%/4%/0.05%. Each gram of TRI-LUMA Cream contains 0.1 mg of fluocinolone acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin. ()

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. ()

No data

TRI-LUMA 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. ()
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. ()

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:
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. ()
To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or n

TRI-LUMA Cream contains the teratogen, tretinoin, which may cause embryofetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. TRI-LUMA Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ()

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: (6u03b1,11u03b2,16u03b1)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.
The molecular formula is CHFO 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 -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 CHO and molecular weight is 110.11.
Hydroquinone has the following structural formula:
Tretinoin, a retinoid, is all--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: ()-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.
The molecular formula is CHO and molecular weight is 300.44.
Tretinoin has the following structural formula:
Each gram of TRI-LUMA Cream contains fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). 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.

No data

When fluocinolone acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, and 150% of the concentrations in the clinical formulation of TRI-LUMA Cream were applied topically to male and female CD-1 mice for up to 24 months at dosages approximating up to 50, 19,000, and 250 u00b5g/kg/day, respectively (corresponding to dosages of 150, 57,000, and 750 u03bcg/m/day, respectively), no statistically significant changes in tumor incidence were observed.
When fluocinolone acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 25%, 50%, and 100% of the concentrations in the clinical formulation of TRI-LUMA Cream were applied topically to male and female SD rats for up to 24 months at dosages approximating up to 10, 4000, and 50 u00b5g/kg/day, respectively (corresponding to dosages of 60, 24,000, and 300 u03bcg/m/day, respectively), statistically significant increases in the incidences of islet cell adenomas and combined islet cell adenomas and carcinomas of the pancreas in both males and females were observed. The clinical relevance of these findings is unknown.
Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
Mutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in studies in mammalian cells, and in the mouse micronucleus assay. Tretinoin has been shown to be negative for mutagenesis in the Ames assay. Additional information regarding the genetic toxicity potential of tretinoin and of fluocinolone acetonide is not available.
A dermal reproductive fertility study was conducted in SD rats using a 10-fold dilution of the clinical formulation. No effect was seen on the traditional parameters used to assess fertility, although prolongation of estrus was observed in some females, and there was a trend towards an increase in pre-and post-implantation loss that was not statistically significant. No adequate study of fertility and early embryonic toxicity of the full-strength drug product has been performed. In a six-month study in minipigs, small testes and severe hypospermia were found when males were treated topically with the full strength drug product.

Two adequate and well-controlled efficacy and safety trials were conducted in 641 subjects between the ages of 21 to 75 years, having Fitzpatrick Skin types I-IV and moderate to severe melasma of the face. 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. Subjects were instructed to apply their study medication each night, after washing their face with a mild soapless cleanser, for 8 weeks. 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. Subjects were provided a mild moisturizer for use as needed. A sunscreen with SPF 30 was also provided with instructions for daily use. Protective clothing and avoidance of sunlight exposure to the face was recommended.
Subjects were evaluated for melasma severity at Baseline and at Weeks 1, 2, 4, and 8 of treatment. Primary efficacy was based on the proportion of subjects who had an investigatorsu2019 assessment of treatment success, defined as the clearing of melasma at the end of the eight-week treatment period. The majority of subjects enrolled in the two trials were white (approximately 66%) and female (approximately 98%). TRI-LUMA Cream was demonstrated to be significantly more effective than any of the other combinations of the active ingredients.
PRIMARY EFFICACY ANALYSIS:
p-value is from Cochran-Mantel-Haenszel chi-square statistics controlling for pooled investigator and comparing TRI-LUMA Cream to the other treatment groups.
In the Investigatorsu2019 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.
Assessment Scale: Cleared (melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation); Mild (slightly darker than the surrounding normal skin); Moderate (moderately darker than the surrounding normal skin); Severe (markedly darker than the surrounding normal skin).
Subjects experienced improvement of their melasma with the use of TRI-LUMA Cream as early as 4 weeks. However, among 7 subjects who had clearing at the end of 4 weeks of treatment with TRI-LUMA Cream, 4 of them did not maintain the remission after an additional 4 weeks of treatment.
After 8 weeks of treatment with the trial drug, subjects entered into an open-label extension period in which TRI-LUMA Cream was given on an as-needed basis for the treatment of melasma. The remission periods appeared to shorten between progressive courses of treatment. Additionally, few subjects maintained complete clearing of melasma (approximately 1 to 2%).

TRI-LUMA Cream is light yellow in color, and supplied in 30 g aluminum tubes, 0299-5950-30.
Arrayn- Storage:

See FDA-approved patient labeling (Patient Information)
Inform patients of the following:
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
P51400-1
or
Manufactured by:
G Production Inc.
Baie du2019Urfu00e9, QC, H9X 3S4 Canada
Made in Canada
P52091-2

PATIENT INFORMATION
TRI-LUMA (try-LOOM-ah)
(fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%)
Cream
Important information: TRI-LUMA Cream is for use on skin only. Do not use TRI-LUMA Cream in your mouth, eyes, or vagina.
What is the most important information I should know about TRI-LUMA Cream?
TRI-LUMA Cream may cause birth defects or death of the baby if used during pregnancy.n- Tell your doctor if you are pregnant or plan to become pregnant.
If you become pregnant while using TRI-LUMA Cream, tell your doctor right away.
What is 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.
TRI-LUMA Cream is not for continuous treatment of melasma.
It is not known if TRI-LUMA Cream is safe and effective in children.
It is not known if TRI-LUMA Cream is safe and effective in people with dark brown to black skin color.
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.
It is not known if TRI-LUMA Cream is safe and effective in females who are pregnant or who are breastfeeding. See and n
Who should not use TRI-LUMA Cream?
Do not use TRI-LUMA Cream if you are allergic to it or any of the ingredients in TRI-LUMA Cream. See the end of this leaflet for a complete list of ingredients in TRI-LUMA Cream.
What should I tell my doctor before using TRI-LUMA Cream?
Before you use TRI-LUMA Cream, tell your doctor if you:
Tell your doctor about all the medicines you take,
How should I use TRI-LUMA Cream?
What should I avoid while using TRI-LUMA Cream?
What are the possible side effects of TRI-LUMA Cream?
TRI-LUMA Cream may cause serious side effects, including:
u2022 TRI-LUMA Cream can pass through your skin.
The most common side effects of TRI-LUMA Cream include:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of TRI-LUMA Cream. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.
How should I store TRI-LUMA Cream?
General information about the safe and effective use of TRI-LUMA Cream
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TRI-LUMA Cream for a condition for which it was not prescribed. Do not give TRI-LUMA Cream to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TRI-LUMA Cream that is written for health professionals.
What are the ingredients in TRI-LUMA Cream?
Active ingredients:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
or
Manufactured by:
G Production Inc.
Baie dUrfu00e9, QC, H9X 3S4 Canada
Made in Canada
Revised: March 2014

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u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
Tri-Luman n- MUST BE REFRIGERATEDn n- NDC
Rx Only
NET WT. 30 g
GALDERMA
For Topical Use Only. Not for Ophthalmic Use.n- Usual dosage:n- Each gram contains: Active:n- Inactive:n- Storage: Store in a refrigerator, 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). Protect from freezingn- MUST BE REFRIGERATED

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Fluocinolone Acetonide, Hydroquinone, And Tretinoin (Tri-Luma)

Trade Name : TRI-LUMA

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Fluocinolone Acetonide, Hydroquinone, And Tretinoin (Tri-Luma)

Trade Name : TRI-LUMA

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

Browse from other international pharmaceuticals

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Swiss Drugs

NZ Drugs

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