SANADERMRX SKIN REPAIR- triamcinolone acetonide cream kit kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GenPak Solutions, LLC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone acetonide cream 0.025% and 0.1% 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. 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. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children 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 corticosteroids to children should be limited t

Product summary:

Triamcinolone Acetonide Cream, USP 0.1% is supplied in tubes containing 80 g (NDC 0603-7862-90).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SANADERMRX SKIN REPAIR- TRIAMCINOLONE ACETONIDE CREAM KIT
GENPAK SOLUTIONS, LLC
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SANADERMRX SKIN REPAIR SOLUTION
TRIAMICOLONE ACETONIDE CREAM USP 0.1% (80 G)
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents. The steroids in this class include
triamcinolone acetonide. Triamcinolone
acetonide is designated chemically as
9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-
dione cyclic 16,17-acetal with acetone. Graphic formula:
Each gram of 0.1% triamcinolone acetonide cream provides 1 mg of
triamcinolone acetonide,
respectively, in a cream base containing cetyl alcohol, isopropyl
palmitate, methyl paraben, mineral
oil/lanolin alcohol, polysorbate 40, propyl paraben, propylene glycol,
propylene glycol monostearate,
purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol
and xanthan gum.
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.
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 sk