Get your patient on Triamcinolone Acetonide - Triamcinolone Acetonide cream (Triamcinolone Acetonide)
Triamcinolone Acetonide - Triamcinolone Acetonide cream prescribing information
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
DOSAGE AND ADMINISTRATION
Apply Triamcinolone Acetonide Cream USP 0.025% to the affected area two to four times daily. Rub in gently. Apply the 0.1% Triamcinolone Acetonide Cream, as appropriate, to the affected area two to three times daily. Rub in gently. 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 and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov /medwatch .
FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only DESCRIPTION
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 24 H 31 FO 6 and molecular weight 434.50. CAS 76-25-5.
Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.
CLINICAL PHARMACOLOGY
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.
HOW SUPPLIED
Triamcinolone Acetonide Cream USP 0.025% 15 gram tubes NDC 0713-0226-15 80 gram tubes NDC 0713-0226-80 Triamcinolone Acetonide Cream USP 0.1% 15 gram tubes NDC 0713-0225-15 30 gram tubes NDC 0713-0225-31 80 gram tubes NDC 0713-0225-80