TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%

/TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%
TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%

ID:

d6e6b280-c430-2686-81bc-e9b5ec851d99

Code:

34391-3

DESCRIPTION


id: 386846bf-128d-48c4-a394-1ad4e6161359
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Each mL of Triamcinolone Acetonide Lotion, USP, 0.025% contains 0.25 mg triamcinolone acetonide in a lotion base containing cetyl alcohol, polysorbate 20, propylene glycol, purified water, simethicone, sorbitan monopalmitate, and stearyl alcohol. 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: fd7ddc85-de83-49b1-a685-0e7274cccc0c
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Topical corticosteroids share anti-inflammatory, antipruritc 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: 997b0831-edec-4231-b3ae-0ca348819b30
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: c7eee736-d197-4d1b-9750-221e1d3592a2
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

ADVERSE REACTIONS


id: f27959b3-1719-b60d-312b-0cfff89a07bf
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: edcbd280-befd-4d41-80bb-8d5651eaf6c3
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: d576e635-99ae-4657-bbb4-f9cb9ee7d3ba
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: 380e7d4e-f67e-4061-92ad-fa149d45bea0
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL NDC 52565-010-59.

PRINCIPAL DISPLAY PANEL – 60 mL Bottle Carton


id: 9c803a9b-baeb-a8a9-4c9e-82cc4e5fcb95
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 52565-010-59 Triamcinolone
Acetonide
Lotion USP, 0.025%
60mL Rx ONLY
For External Use Only
Not for Ophthalmic Use