TRIDERM

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION Apply to the affected area as a thin film from two to four times daily for the 0.025% strength and two or three times daily for the 0.1% and 0.5% strength depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

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

ADVERSE REACTIONS 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, miliaria.

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Triamcinolone acetonide is chemically 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 24 H 31 FO 6 and molecular weight 434.50. Its structural formula is: Each gram of Triderm (Triamcinolone Acetonide Cream USP), 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triderm (Triamcinolone Acetonide Cream USP), 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triderm (Triamcinolone Acetonide Cream USP), 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. TA structure

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS )

HOW SUPPLIED Triderm (Triamcinolone Acetonide Cream USP), 0.025% is supplied in: 15 grams tube NDC 0316-0165-15 85.2 grams tube NDC 0316-0165-85 454 grams jar NDC 0316-0165-16 Triderm (Triamcinolone Acetonide Cream USP), 0.1% is supplied in: 28.4 grams tube NDC 0316-0170-01 85.2 grams tube NDC 0316-0170-03 Triderm (Triamcinolone Acetonide Cream USP), 0.5% is supplied in: 15 grams tube NDC 0316-0175-15 454 grams jar NDC 0316-0175-16