FLUOCINOLONE ACETONIDE- fluocinolone acetonide solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Fluocinolone Acetonide (UNII: 0CD5FD6S2M) (Fluocinolone Acetonide - UNII:0CD5FD6S2M)

Διαθέσιμο από:

Cosette Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

Fluocinolone Acetonide

Σύνθεση:

Fluocinolone Acetonide 0.1 mg in 1 mL

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Fluocinolone Acetonide Topical Solution, USP 0.01% is 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 hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (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. Adm

Περίληψη προϊόντος:

Fluocinolone Acetonide Topical Solution, USP 0.1% is supplied in a 60 mL Bottle (NDC 0713-0325-53).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE SOLUTION
COSETTE PHARMACEUTICALS, INC.
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FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01%
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Topical Solution, USP 0.01% is intended for
topical administration. The active
component is the corticosteroid fluocinolone acetonide, which has the
chemical name pregna-1,4-
diene-
3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)
bis (oxy)]-, (6α,11β,16α)-.
It has the following chemical structure:
Fluocinolone Acetonide Topical Solution, USP 0.01% contains
fluocinolone acetonide 0.1 mg/mL in a
water-washable base of citric acid and propylene glycol.
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
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 skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to
systemically administered corticosteroids. Corticosteroids are bound
to plasma proteins in varying
degrees. Corticostero