TRIDERM- triamcinolone acetonide cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Crown Laboratories

DCI (Denominação Comum Internacional):

TRIAMCINOLONE ACETONIDE

Composição:

TRIAMCINOLONE ACETONIDE 5 mg in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. 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. Hypothalamic-pituitary-adrenaI (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 cortico

Resumo do produto:

Triderm (Triamcinolone Acetonide Cream USP), 0.025% is supplied in: 15 grams tube NDC 0316-0165-15 85.2 grams tube NDC 0316-0165-85 454 grams jar NDC 0316-0165-16 Triderm (Triamcinolone Acetonide Cream USP), 0.1% is supplied in: 28.4 grams tube NDC 0316-0170-01 85.2 grams tube NDC 0316-0170-03 Triderm (Triamcinolone Acetonide Cream USP), 0.5% is supplied in: 15 grams tube NDC 0316-0175-15 454 grams jar NDC 0316-0175-16

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TRIDERM- TRIAMCINOLONE ACETONIDE CREAM
CROWN LABORATORIES
----------
TRIDERM (TRIAMCINOLONE ACETONIDE CREAM USP), 0.025%, 0.1%, 0.5%
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and antipruritic agents. Triamcinolone acetonide is a
member of this class.
Triamcinolone acetonide is chemically 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. Its structural formula is:
Each gram of Triderm (Triamcinolone Acetonide Cream USP), 0.025%
contains 0.25 mg
triamcinolone acetonide USP in a cream base consisting of purified
water, emulsifying
wax, mineral oil, propylene glycol, sorbitol solution, cetyl
palmitate, sorbic acid, and
potassium sorbate.
Each gram of Triderm (Triamcinolone Acetonide Cream USP), 0.1%
contains 1 mg
triamcinolone acetonide USP in a cream base consisting of purified
water, emulsifying
wax, mineral oil, propylene glycol, sorbitol solution, cetyl
palmitate, sorbic acid, and
potassium sorbate.
Each gram of Triderm (Triamcinolone Acetonide Cream USP), 0.5%
contains 5 mg
triamcinolone acetonide USP in a cream base consisting of purified
water, emulsifying
wax, mineral oil, propylene glycol, sorbitol solution, cetyl
palmitate, sorbic acid, and
potassium sorbate.
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.
24
31
6
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including the vehicle, the integrity of the ep