TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 C24 H31 FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of  mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of  mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyo

Product summary:

Triamcinolone Acetonide Cream USP 0.025%              15 gram tubes                                    

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
AIDAREX PHARMACEUTICALS LLC
----------
TRIAMCINOLONE ACETONIDE CREAM USP
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
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 USP per
gram in a water washable cream base consisting of mineral oil (and)
lanolin alcohol, isopropyl
palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl
alcohol NF, sorbitan
monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40)
stearate NF, propylparaben NF,
methylparaben NF and purified water USP.
Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone
acetonide USP per gram in
a water washable cream base consisting of mineral oil (and) lanolin
alcohol, isopropyl palmitate NF,
propylene glycol stearate, propylene glycol USP, cetyl alcohol NF,
sorbitan monostearate NF,
polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF,
propylparaben NF, methylparaben NF
and purified water USP.
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
24
31
6
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 norm