FLUOCINOLONE ACETONIDE OIL, 0.01%- EAR DROPS oil

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Tasman Pharma Inc.

Indgivelsesvej:

AURICULAR (OTIC)

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older. Fluocinolone acetonide oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (See PRECAUTIONS).

Produkt oversigt:

Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 72641-002-20). Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F.) [see USP Controlled Room Temperature]. Discard fluocinolone acetonide oil, 0.01% 2 months after initial use.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) - FLUOCINOLONE ACETONIDE
OIL, 0.01% (EAR DROPS) OIL
TASMAN PHARMA INC.
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FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS)
FOR OTIC USE ONLY-
NOT FOR OPHTHALMIC USE
DESCRIPTION
Fluocinolone acetonide oil, 0.01% (ear drops) contain fluocinolone
acetonide, USP {(6α,
11β,
16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-
diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic
corticosteroid.
Chemically, fluocinolone acetonide, USP is C
H
F O . It has the following structural
formula:
Fluocinolone acetonide, USP in fluocinolone acetonide oil, 0.01% has a
molecular weight
of 452.49. It is a white crystalline powder that is odorless, stable
in light, and melts at
270°C with decomposition; soluble in alcohol, acetone and methanol;
slightly soluble in
chloroform; insoluble in water.
Each gram of fluocinolone acetonide oil, 0.01% contains approximately
0.11 mg of
fluocinolone acetonide, USP in a blend of oils, which contains
isopropyl alcohol, isopropyl
myristate, light mineral oil, oleth-2, and refined peanut oil NF.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, fluocinolone acetonide has
anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
activity of the topical steroids, in general, is unclear. However,
corticosteroids are
thought to act by the induction of phospholipase A inhibitory
proteins, collectively called
24
30 2
6
thought to act by the induction of phospholipase A inhibitory
proteins, collectively called
lipocortins. It is postulated that these proteins control the
biosynthesis of potent
mediators of inflammation such as prostaglandins and leukotrienes by
inhibiting the
release of their common precursor arachidonic acid. Arachidonic acid
is released from
membrane phospholipids by phospholipase A .
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including the vehicle and the integrity of th