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
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing 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 preparations.
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.
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11ß,16α)-. C 24 H 31 FO 6 , and M.W. of 434.51; CAS Reg. No. 76-25-5.
Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate.
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.
Pharmacokinetics -
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
HOW SUPPLIED
Triamcinolone Acetonide Cream USP, 0.025% is available as follows:
15 g tube (NDC 45802- 063 -35)
80 g tube (NDC 45802- 063 -36)
454 g jar (NDC 45802- 063 -05)
Triamcinolone Acetonide Cream USP, 0.1% is available as follows:
15 g tube (NDC 45802- 064 -35)
80 g tube (NDC 45802- 064 -36)
454 g jar (NDC 45802- 064 -05)
Triamcinolone Acetonide Cream USP, 0.5% is available as follows:
15 g tube (NDC 45802- 065 -35)
