TRIAMCINOLONE ACETONIDE CREAM USP, 0.1%

DESCRIPTION:

id: 6c35098b-4b08-6bbf-e053-2991aa0a79af
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C
₂₄H
₃₁FO
₆ and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.

CLINICAL PHARMACOLOGY:

id: 6c312d10-925c-cda3-e053-2a91aa0a1448
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

INDICATIONS AND USAGE:

id: 6c312d10-925e-cda3-e053-2a91aa0a1448
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

CONTRAINDICATIONS:

id: 6c312d10-925f-cda3-e053-2a91aa0a1448
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ADVERSE REACTIONS:

id: 6c312d10-9269-cda3-e053-2a91aa0a1448
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. To report
SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE:

id: 6c312d10-926a-cda3-e053-2a91aa0a1448
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See

PRECAUTIONS
).

DOSAGE AND ADMINISTRATION:

id: 6c312d10-926b-cda3-e053-2a91aa0a1448
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply triamcinolone acetonide cream, 0.1% as appropriate, to the affected area two to three times daily. Rub in gently. Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED:

id: 6c312d10-926c-cda3-e053-2a91aa0a1448
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Cream USP, 0.1% is supplied in the following:

15 g tube (NDC: 52565-056-15)

30 g tube (NDC: 52565-056-30)

80 g tube (NDC: 52565-056-80)

1 lb jar (454 g) (NDC: 52565-056-26)

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. Manufactured by:

Teligent Pharma, Inc.

Buena, NJ 08310

Revised: 04/2017