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.

INN (International Name):

fluocinolone acetonide

Composition:

fluocinolone acetonide 0.1 mg in 1 mL

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%   60 mL Bottle with applicator tip – NDC 43538-920-60   90 mL Bottle with applicator tip – NDC 43538-920-90 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.

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.
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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 th