TRIAMCINOLONE ACETONIDE ointment

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

제공처:

Proficient Rx LP

INN (국제 이름):

TRIAMCINOLONE ACETONIDE

구성:

TRIAMCINOLONE ACETONIDE 5 mg in 1 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Topical corticosteroids are 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.

제품 요약:

Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 g tube (NDC 63187-495-15)

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT
PROFICIENT RX LP
----------
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%, 0.5%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and anti-pruritic agents. Triamcinolone acetonide is
designated chemically
as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-
methylethylidene)bis(oxy)]-, (11β,16α)-. C
H
FO , M.W. 434.51; CAS Reg. No. 76-25-
5.
Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or
0.5% contains
0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an
ointment base of
light mineral oil and white petrolatum.
24
31
6
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic 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