FLUOCINOLONE ACETONIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

FLUOCINOLONE ACETONIDE

Composition:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are 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.

Product summary:

Fluocinolone Acetonide Topical Solution, USP 0.01% in 60 mL bottles, NDC 54868-2264-1 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 I259C R12/07 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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FLUOCINOLONE ACETONIDE TOPICAL
SOLUTION USP, 0.01%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Topical Solution USP, 0.01% contains
fluocinolone acetonide USP (Pregna-
1,4-diene-3,20-dione,
6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,
(6α,11β,16α)-); it has an empirical formula of C
H
F
O
and a molecular weight of 425.49 (CAS
Registry Number 67-73-2).
Each mL of the topical solution contains 0.1 mg fluocinolone acetonide
in a base containing propylene
glycol and citric acid.
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 the 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.
(SeeDOSAGE AND
ADMINISTRATION ). Once absorbed through the skin, topical
corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered
corticosteroids. Corticosteroids are
24
30
2
6
bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver and