FLUOCINOLONE ACETONIDE oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 old 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).

Product summary:

Fluocinolone Acetonide Oil 0.01% Ear Drops is supplied in 1 fluid ounce bottles with a net contents of 20 mL (Dropper Included) (NDC # 65162-702-94). 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]. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or www.amneal.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION: Rx only Distributed by: Amneal Pharmaceuticals Bridgewater, NJ  08807 Rev. 08-2015-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
AMNEAL PHARMACEUTICALS LLC
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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 {(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 is C
H
F O anhydrous. It has the following
structural formula:
24
30
2
6
Fluocinolone acetonide 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
270ºC 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 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
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
the epidermal
barrier. Occlusion of topical corticosteroids can enhance penetration.
Topical
corticosteroids can be absorbed from normal intact skin. A