
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
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
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
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
CONTRAINDICATIONS
id: d7407388-46cd-4077-872e-ea9fdc878473
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
ADVERSE REACTIONS
id: e89f4686-6f24-4531-9d48-bf48ef3465cf
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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
DOSAGE & ADMINISTRATION
id: 60719e2c-72d7-41eb-b5c1-2e22781dea5c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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
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
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
Triamcinolone Acetonide Cream USP, 0.025%
Ascend Laboratories LLC
15 gm