TRIAMCINOLONE ACETONIDE cream

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
09-12-2023

유효 성분:

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

제공처:

A-S Medication Solutions

INN (International Name):

TRIAMCINOLONE ACETONIDE

구성:

TRIAMCINOLONE ACETONIDE 0.25 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 preparation.

제품 요약:

Product: 50090-0293 NDC: 50090-0293-1 80 g in a TUBE / 1 in a CARTON

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
A-S MEDICATION SOLUTIONS
----------
TRIAMCINOLONE ACETONIDE CREAM USP,
0.025%, 0.1%, 0.5%
RX ONLY
DESCRIPTION:
Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide
[Pregna-1,4-
diene-3,20-dione,
9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-,
(11β,16α)-], with the empirical formula C
H
FO and molecular weight 434.50. CAS
76-25-5.
Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of
Triamcinolone
Acetonide per gram in a base containing Emulsifying Wax, Cetyl
Alcohol, Isopropyl
Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol
and Purified Water.
Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of
Triamcinolone Acetonide
per gram in a base containing Emulsifying Wax, Cetyl Alcohol,
Isopropyl Palmitate,
Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified
Water.
Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of
Triamcinolone Acetonide
per gram in a base containing Emulsifying Wax, Cetyl Alcohol,
Isopropyl Palmitate,
Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified
Water.
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
24
31
6
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 dressin
                                
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