TRIAMCINOLONE ACETONIDE, LOTION, USP 0.1%, FOR TOPICAL USE ONLY

/TRIAMCINOLONE ACETONIDE, LOTION, USP 0.1%, FOR TOPICAL USE ONLY
TRIAMCINOLONE ACETONIDE, LOTION, USP 0.1%, FOR TOPICAL USE ONLY2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRIAMCINOLONE ACETONIDE, LOTION, USP 0.1%, FOR TOPICAL USE ONLY

ID:

44e205df-1296-452a-a985-e01b40343af8

Code:

34391-3

DESCRIPTION


id: bd9c491b-abcf-4805-969f-3659a574b31b
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Triamcinolone Acetonide Lotion, USP is supplied in the following strengths: 0.025%, 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg triamcinolone acetonide, USP in a lotion base containing citric acid, cetyl alcohol, dimethicone, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. The molecular formula is C24H31FO6. It has the following structure:

M.W. 434.51

CLINICAL PHARMACOLOGY


id: 59ea37f8-493c-4aff-ae6c-3f5743021f8e
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 AND USAGE


id: e40e770f-7bcb-4c3c-b8d4-0dbe34d0bc68
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS


id: 76f20845-3d72-4f13-8fcd-a22d47b920e3
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 preparation.

ADVERSE REACTIONS


id: fe6a10f1-26e7-43e8-b75d-67ac58322251
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 Perioral dermatitis
Itching Allergic contact dermatitis
Irritation Maceration of the skin
Dryness Secondary infection
Folliculitis Skin Atrophy
Hypertrichosis Striae
Acneiform eruptions Miliaria
Hypopigmentation

OVERDOSAGE


id: 665e5bcb-4972-4304-9c76-d1294acc2578
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION


id: 491417c4-e380-4c18-b546-18f1d6f5597a
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED


id: 49adbb10-2e0b-445c-a5a6-0403be6706d3
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL.

PRINCIPAL DISPLAY PANEL – 60 mL Bottle Label


id: 49dbc3c5-e52f-4c0e-87b2-1c4ae5fbb0f7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

MGP NDC 60432-561-60 TRIAMCINOLONE
ACETONIDE
LOTION, USP 0.1%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
Rx Only NET: 60 mL