Triamcinolone Acetonide 0.05% In Absorbase®

/Triamcinolone Acetonide 0.05% In Absorbase®
Triamcinolone Acetonide 0.05% In Absorbase®2018-09-06T09:12:40+00:00

Prescription Drug Name:

Triamcinolone Acetonide 0.05% In Absorbase®

ID:

b629aa5b-c0fc-4ae7-a2d3-bb1bec07a20e

Code:

34391-3

DESCRIPTION


id: 47848435-0531-40d9-8c04-55ba7d4f02cf
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Topical corticosteroids, such as triamcinolone acetonide, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment USP) contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, and Lanolin Alcohols NF. The white ointment is for topical use only. Triamcinolone Acetonide has the molecular formula of C24H31FO6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-. It has a molecular weight of 434.50 and the following structural formula:

CLINICAL PHARMACOLOGY


id: 775c3570-3795-49df-a437-9769bf1dcc28
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.

INDICATIONS AND USAGE


id: ec23b743-c103-4209-84fa-9de24f0861d5
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone Acetonide 0.05% in Absorbase® is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

CONTRAINDICATIONS


id: 0e5e7004-91c9-40cd-9604-de97f4814ad7
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Triamcinolone Acetonide 0.05% in Absorbase® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ADVERSE REACTIONS


id: 0f2caa36-4925-4d73-bbc5-30f7adcea104
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: c2be09d9-398d-4c94-9487-3d9b88128105
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: f912c8d3-d023-4866-96a6-e11e9614d185
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Triamcinolone Acetonide 0.05% in Absorbase® is generally applied to the affected area as a thin film from two 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: 1774d957-9537-47a7-8fe5-0595d7dde595
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide 0.05% in Absorbase® (Triamcinolone Acetonide Ointment USP) is supplied in 430 g jars (NDC 46287-010-16). STORE AT CONTROLLED ROOM TEMPERATURE 15°-30° C (59°-86° F). DISPENSE IN A WELL-CLOSED CONTAINER. CAUTION: Federal law prohibits dispensing without prescription. For external use only. Not for ophthalmic use. Carolina Medical Products Co. Post Office Box 147 Farmville, North Carolina 27828 Revised June 1993 Copyright © Carolina Medical Products Co. 1991

PRINCIPAL DISPLAY PANEL


id: 5f35f736-73f8-43b1-9f02-ceec42d54ed6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 46287-010-16 430 g TRIAMCINOLONE ACETONIDE 0.05% IN ABSORBASE®

Triamcinolone Acetonide Ointment, USP Each gram contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil
emulsion composed of Light Mineral Oil NF, Purified Water USP, White
Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, Lanolin Alcohols NF.
CAUTION: Federal law prohibits dispensing without prescription.
STORE AT CONTROLLED ROOM TEMPERATURE 15°-30° C (59°-86° F).
USUAL DOSAGE: Apply a thin film to the affected area two to four times daily.
See package insert for information.
Dispense in a well-closed container.
FOR EXTERNAL USE ONLY. NOT FOR OPTHALMIC USE.

Keep out of reach of children. LOT:
EXP:
Carolina Medical Products Co.
Post Office Box 147 • Farmville, NC 27828

Jar Label