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:

A-S Medication Solutions

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 0.25 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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