TRI-LUMA Cream (2014)

Βιβλιογραφική αναφορά

Συγγραφείς

Galderma Laboratories, L.P.

Λέξεις κλειδιά

0299-5950

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1. Indications and Usage

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 ...

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 ...

4. Contraindications

TRI-LUMA Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.

5. Warnings and Precautions

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 ...

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 ...

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 ...

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 ...

8.4. Pediatric Use

Safety and effectiveness of TRI-LUMA Cream in pediatric patients have not been established.

8.5. Geriatric Use

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. Other reported clinical experience ...

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 ...

12.1. Mechanism of Action

The mechanism of action of the active ingredients in TRI-LUMA Cream in the treatment of melasma is unknown.

12.3. Pharmacokinetics

Percutaneous absorption of unchanged tretinoin, hydroquinone and fluocinolone acetonide into the systemic circulation of two groups of healthy volunteers (Total N=59) was found to be minimal following ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

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 ...

14. Clinical Studies

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. ...

16.1. How Supplied

TRI-LUMA Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, TX 76177 USA Manufactured by: Hill Dermaceuticals, ...

16.2. Storage and Handling

<u>Storage:</u> Keep tightly closed. Store in a refrigerator, 2°-8°C (36°-46°F). Protect from freezing.

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information) Inform patients of the following: Advise patients to change to non-hormonal forms of birth control, if hormonal methods are used. Use TRI-LUMA Cream ...