TRIAMCINOLONE ACETONIDE

Topical corticosteroids, such as Triamcinolone acetonide ointment, USP 0.05% constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Triamcinolone acetonide ointment, USP 0.05% contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Mineral Oil NF, Mineral Wax, Lanolin Alcohols NF and Sorbitan Sesquioleate NF. The white to off-white ointment is for topical use only. Triamcinolone Acetonide has the molecular formula of C 24 H 31 FO 6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-. It has a molecular weight of 434.50 and the following structural formula: 128

INDICATIONS & USAGE Triamcinolone acetonide ointment 0.05%, USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

DOSAGE & ADMINISTRATION Apply a thin film to the affected area two to four times a day. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a 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 Ointment under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment 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.

Triamcinolone acetonide ointment 0.05%, USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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.