TRIAMCINOLONE ACETONIDE- triamcinolone acetonide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Triamcinolone Acetonide (UNII: F446C597KA) (Triamcinolone Acetonide - UNII:F446C597KA)

Available from:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Triamcinolone Acetonide

Composition:

Triamcinolone Acetonide 5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone Acetonide Ointment, USP 0.5% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be li

Product summary:

Triamcinolone Acetonide Ointment, USP 0.5% is available as follows: 15 g tube (NDC 0713-0679-15)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.5%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents.The steroids in this class include
triamcinolone acetonide. Triamcinolone
acetonide is designated chemically as 9-Fluoro-11β,
16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-
dione cyclic 16,17-acetal with acetone. The structural formula of
triamcinolone acetonide is as
follows:
Each gram of Triamcinolone Acetonide Ointment, USP 0.5% provides 5 mg
triamcinolone acetonide in
an ointment base of light mineral oil and white petrolatum.
CLINICAL PHARMACOLOGY
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
ar