TRIAMCINOLONE ACETONIDE LOTION, USP, 0.1%

/TRIAMCINOLONE ACETONIDE LOTION, USP, 0.1%
TRIAMCINOLONE ACETONIDE LOTION, USP, 0.1%2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRIAMCINOLONE ACETONIDE LOTION, USP, 0.1%

ID:

35749bcd-9528-4b12-a473-56f6209b1bce

Code:

34391-3

DESCRIPTION


id: 08732a05-f07f-4b70-97c8-1e46ffa227ab
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: Each mL of 0.1% triamcinolone acetonide lotion provides 1 mg triamcinolone acetonide in a lotion base containing cetyl alcohol, citric acid, polysorbate 20, propylene glycol, purified water, simethicone 30% emulsion, sorbitan monopalmitate and stearyl alcohol.

CLINICAL PHARMACOLOGY


id: 68b21109-4403-49db-89d0-ab375b2341ae
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: 87289600-4a60-4954-9caa-1b963ccc68ab
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone acetonide lotion 0.1% is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS


id: 38b144ab-7383-4912-992c-661b9a4d00e7
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: 9d31545b-6f09-4132-8cfe-cfedbbadba5c
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: 7e9f429f-0a1b-4ac1-82aa-7e61c8dbbfa5
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: 227bc9c0-c4d2-4c88-9729-d0d251930ea5
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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

HOW SUPPLIED


id: 1491e728-6247-44fe-9788-0a77d94d4e31
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Lotion, USP 0.1%: plastic squeeze bottles containing 60 mL of lotion

PRINCIPAL DISPLAY PANEL


id: eddfed76-af87-414c-9ff7-f92ee83593ea
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4