SYNALAR- fluocinolone acetonide ointment

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

から入手可能:

Medimetriks Pharmaceuticals, Inc.

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

SYNALAR® Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

製品概要:

SYNALAR® (fluocinolone acetonide) Ointment, 0.025% is supplied in Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

認証ステータス:

New Drug Application

製品の特徴

SYNALAR- FLUOCINOLONE ACETONIDE OINTMENT
MEDIMETRIKS PHARMACEUTICALS, INC.
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SYNALAR
(FLUOCINOLONE ACETONIDE)
OINTMENT, 0.025%
RX ONLY
DESCRIPTION
SYNALAR (fluocinolone acetonide) Ointment 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:
SYNALAR Ointment contains fluocinolone acetonide 0.25 mg/g 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 the
topical corticoster