SYNALAR- fluocinolone acetonide solution SYNALAR TS- fluocinolone acetonide kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medimetriks Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SYNALAR® Solution 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.

Product summary:

SYNALAR® (fluocinolone acetonide) Topical Solution, 0.01% Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). Store in an upright position. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

Authorization status:

New Drug Application

Summary of Product characteristics

SYNALAR- FLUOCINOLONE ACETONIDE SOLUTION
SYNALAR TS- FLUOCINOLONE ACETONIDE
MEDIMETRIKS PHARMACEUTICALS, INC.
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SYNALAR
(FLUOCINOLONE ACETONIDE)
TOPICAL SOLUTION, 0.01%
RX ONLY
DESCRIPTION
SYNALAR (fluocinolone acetonide) Topical Solution, 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:
SYNALAR Solution 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. Corticosteroids are metabolized primarily in t