TRIAMCINOLONE ACETONIDE 15G

/TRIAMCINOLONE ACETONIDE 15G
TRIAMCINOLONE ACETONIDE 15G2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRIAMCINOLONE ACETONIDE 15G

ID:

4a41d462-748c-40f1-8fd6-c000959a00cd

Code:

34391-3

DESCRIPTION


id: c5d9fdf7-2e2b-411d-b497-384834ac434b
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. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is:

Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

CLINICAL PHARMACOLOGY


id: 7dbfef95-af7d-426f-bbc8-05d5a36c32ed
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.
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION)
 Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS & USAGE


id: a0034fe8-a825-40bd-a816-a266044775c4
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS


id: ba9f5b30-2eca-4d31-a33d-1830a38f44ec
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

 Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ADVERSE REACTIONS


id: 19e8c287-b9d3-4186-82f4-d1cefc2c17f8
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
Miliaria

OVERDOSAGE


id: d6ebff3c-5c5a-4729-941d-93987e96a9d7
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: 664ead24-3746-43cf-8684-aa77f0b09cb7
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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

HOW SUPPLIED


id: 4417846b-7eef-4b37-8d00-dec014fc2fd4
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone acetonide cream USP 0.1% is supplied in

30 GRAM in a TUBE (0440-0251-30)
45 GRAM in a JAR (0440-0251-45)
80 GRAM in a TUBE (0440-0251-80)
15 GRAM in a TUBE (0440-0251-15)
Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature].
Avoid excessive heat. Protect from freezing.

PRINTED IN USA

Packaged by: AIDAREX PHARMACEUTICALS LLC. CORONA, CA 92880.

Revised: 07/2016

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL


id: ee1c5544-10ec-4633-a7ac-8e5cf13a59fd
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL


id: 77f77b73-82af-433e-a51e-d3365d2b77bd
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

 

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL


id: c73b051d-13e4-499a-80b1-2a15354c32dc
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

 

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL


id: 5ce3e310-5370-4867-b10b-ddfd4a49a72d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4