Prescription Drug Name:

TRIAMCINOLONE ACETONIDE CREAM, USP, 0.025% and 0.1%

ID:

0e7996ef-d598-4807-afa3-a0329d0da5e9

Code:

34391-3

DESCRIPTION


id: 2f3822e9-efe9-4664-bd85-21eb0e7a7502
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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:

CLINICAL PHARMACOLOGY


id: dfb3d9c1-9b2f-4caf-9faf-5d8f50465bcf
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Topical corticosteroids share anti-inflammatory, antipruritic 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 AND USAGE


id: a69d78d6-6d4f-431e-8685-33a511d9d225
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS


id: bb08d20b-4bca-4f39-b597-82a48b247617
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

ADVERSE REACTIONS


id: a7e2f852-1196-4770-8d15-1218b140ef9c
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 (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


id: 1b10e689-8d17-4cac-8d52-03f93f0d481b
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION


id: ec04b0b2-5e48-46a3-bcec-66750855ba3a
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply triamcinolone acetonide cream 0.025% to the affected area two to four times daily. Rub in gently. Apply the 0.1% triamcinolone acetonide cream to the affected area two to three times daily. Rub in gently.

HOW SUPPLIED


id: 31c30dd0-b618-4948-bd10-e42cfefd21a9
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Cream, USP 0.025%: tubes containing 15 g (NDC 0603-7861-74) and 80 g (NDC 0603-7861-90); and jars containing 454 g of cream (NDC 0603-7861-97). 0.1%: tubes containing 15 g (NDC 0603-7862-74), 30 g (NDC 0603-7862-78), and 80 g (NDC 0603-7862-90); and jars containing 454 g of cream (NDC 0603-7862-97).

PRINCIPAL DISPLAY PANEL


id: 8871a44f-2b41-4823-a3c4-808d56b5ff04
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 8f2a931f-21ee-49f3-a4c8-c7cadaba0e87
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 60dbcc00-7dbe-4511-81aa-abae320ada76
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 4de68d8b-396a-4fda-878c-25755fff1bed
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL


id: 8f5d36f0-f368-43c7-be08-88fd776154a9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4