Triamcinolone Acetonide Cream USP 0.025%,0.1%,0.5%, Rx only

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5.

The structural formula is:

CLINICAL PHARMACOLOGY

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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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.

INDICATIONS & USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

id: e351047d-a8df-4a96-8180-a0bec9245e10
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Triamcinolone Acetonide Cream USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

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displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

General Systemic absorption of topical corticosteroids has produced reversible hypothalamic pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. These preparations are not for ophthalmic use.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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.

OVERDOSAGE

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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE & ADMINISTRATION

id: 46483f74-3a0a-42ad-a4d6-f8c68439fb5d
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply Triamcinolone Acetonide Cream USP 0.025% to the affected area two to four times daily. Rub in gently. Apply the 0.1% or the 0.5% Triamcinolone Acetonide Cream USP, as appropriate, to the affected area two to three times daily. Rub in gently. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream 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 cream USP 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 cream 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.

HOW SUPPLIED

id: aa79b83d-2525-4926-ae0a-a984c9511455
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone  Acetonide Cream USP, 0.025% 15 gram tubes:  NDC67877-470-75 30 gram tubes:  NDC67877-470-76 80 gram tubes:   NDC67877-470-77 Triamcinolone  Acetonide Cream 
 USP, 0.1 % 15 gram tubes:  NDC67877-471-75 30 gram tubes:  NDC67877-471-76 80 gram tubes:   NDC67877-471-77 Triamcinolone  Acetonide Cream 
 USP, 0.5 % 15 gram tubes:   NDC67877-472-75 30 gram tubes:   NDC67877-472-76 80 gram tubes:    NDC67877-472-77 Store at controlled room temperature 15°-30 °C (59°-86°F). Avoid excessive heat. Protect from freezing. Manufactured by: Torrent Pharmaceuticals Ltd. Pithampur-454775, INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: October, 2017

PT 2326

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

id: 1f8f6b84-ee16-4af7-9766-a92c288fdd45
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Triamcinolone Acetonide Cream USP, 0.025%
15 gram tube:  NDC 67877-470-75

Triamcinolone Acetonide Cream
 USP, 0.1%
30 gram tube:  NDC 67877-471-76

Triamcinolone Acetonide Cream
 USP, 0.5%
80 gram tube:  NDC 67877-472-77