FLUOCINOLONE ACETONIDE ointment

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Teligent Pharma, Inc.

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Fluocinolone Acetonide Ointment 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 components of the preparation.

Produkto santrauka:

Fluocinolone Acetonide Ointment USP,0.025% is supplied in 15 g Tube - NDC 52565-013-15 60 g Tube – NDC 52565-013-60 Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F).

Autorizacija statusas:

New Drug Application Authorized Generic

Prekės savybės

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OINTMENT
TELIGENT PHARMA, INC.
----------
FLUOCINOLONE ACETONIDE OINTMENT USP, 0.025%
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Ointment USP,0.025% 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-dihydroxy16,17[(methylethylidene)bis(oxy)]-,
(6α,11β,16α)-. It has
the following chemical structure:
Fluocinolone Acetonide Ointment USP contains fluocinolone acetonide
0.25 mg/g in a white petrolatum
USP vehicle.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritc 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 the 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. Corticosteroids are metabolized primarily in the
liver and are then excreted by the
kidneys. Some of the topical corticosteroid