FLUOCINOLONE ACETONIDE ointment

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Mevcut itibaren:

ANI Pharmaceuticals, Inc.

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 the components of the preparation.

Ürün özeti:

Fluocinolone Acetonide Ointment USP, 0.025% is supplied in      15 g Tube – NDC 62559-299-15      60 g Tube – NDC 62559-299-60

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OINTMENT
ANI PHARMACEUTICALS, INC.
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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-dihydroxy-16,17-[(1-
methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following
chemical structure:
Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of
fluocinolone
acetonide USP in a white petrolatum USP vehicle.
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.
Corticosteroids are
metabolized primarily in the liver and are then excreted by the
kidneys. Some of