Fluocinolone Acetonide, Hydroquinone, And Tretinoin
Generic Name: fluocinolone acetonide, hydroquinone, and tretinoin
Brand Names:
Tri-luma
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.
Overview
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.
Uses
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.
Dosage
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.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS 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. ( 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. 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
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.
Storage
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.
Frequently Asked Questions
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.
What are the side effects of Fluocinolone Acetonide, Hydroquinone, And Tretinoin?▼
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.
Can I take Fluocinolone Acetonide, Hydroquinone, And Tretinoin during pregnancy?▼
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.
What are the important warnings for Fluocinolone Acetonide, Hydroquinone, And Tretinoin?▼
5 WARNINGS AND PRECAUTIONS 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. ( 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. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.