TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%, 0.1%

Rx only

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 is designated chemically as 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

Graphic formula:

Each mL of 0.025% and 0.1% Triamcinolone Acetonide Lotion provides 0.25 mg and 1 mg triamcinolone acetonide, respectively, in a lotion base containing propylene glycol, cetyl alcohol, stearyl alcohol, sorbitan monopalmitate, polysorbate 20, simethicone, and purified water.

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.

Triamcinolone Acetonide Lotion 0.025% and 0.1% are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are uled 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.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General).

Apply the 0.025% Triamcinolone Acetonide Lotion to the affected area two to four times daily, Rub in gently.

Apply the 0.1% Triamcinolone Acetonide Lotion to the affected area two to three times daily. Rub in gently.

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of lotion 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 Lotion 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 lotion 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 Lotion USP, 0.025%; plastic squeeze bottles containing

60 mL NDC 0168-0336-60

Triamcinolone Acetonide Lotion USP, 0.1%; plastic squeeze bottles containing

60 mL NDC 0168-0337-60

Store at room temperature; avoid freezing.

E. FOUGERA & CO. I2337
a division of Altana Inc. R10/02
MELVILLE, NEW YORK 11747 #69

I2337
R10/02#69