TRIAMCINOLONE-ASCEND

/TRIAMCINOLONE-ASCEND
TRIAMCINOLONE-ASCEND2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRIAMCINOLONE-ASCEND

ID:

9a555e48-c21e-4bc0-a7c3-ec22b5a40f63

Code:

34391-3

DESCRIPTION


id: df31d327-01a3-41ab-b15a-053787807e71
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: 99595c19-6fb5-48d6-a502-9e2a8d04bff6
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: 25d93d6f-58ed-46a5-90ae-e164b71e2def
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: d7407388-46cd-4077-872e-ea9fdc878473
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: e89f4686-6f24-4531-9d48-bf48ef3465cf
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: e6735278-1ab5-4bd2-a43e-46a4d5173c69
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: 60719e2c-72d7-41eb-b5c1-2e22781dea5c
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: 5b74dfeb-b42f-471f-a689-aedd25dc827a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone acetonide cream USP 0.025% is supplied in
15 g tube NDC 0440-317-15
80 g tube NDC 0440-317-80
454 g jar NDC 0440-317-45

Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature].
Avoid excessive heat. Protect from freezing.

PRINTED IN USA

Manufactured for:  Ascend Laboratories, LLC Montvale, NJ 07645
Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Repackaged By: Aidarex Pharmaceuticals, LLC Corona, CA 92882

P1810.01

Revised: Sept 2015

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: db394774-b9a1-4db7-a9c9-b2dfbf8c272a
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4


NDC 67877-317-15
Triamcinolone Acetonide Cream USP, 0.025%
Ascend Laboratories LLC

15 gm