FLUOCINOLONE ACETONIDE- fluocinolone acetonide oil

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AvKARE, Inc.

Via de administração:

AURICULAR (OTIC)

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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).

Resumo do produto:

Fluocinolone Acetonide Oil 0.01% Ear Drops is supplied in 1 fluid ounce bottles with a net contents of 20 mL (Dropper Included) (NDC # 42291-283-20). 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] To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION: Rx only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876 Mfg. Rev. 08-2015-00 AV Rev. 01/16

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
AVKARE, INC.
----------
FLUOCINOLONE ACETONIDE OIL 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:
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 :
24
30
2
6
2
2
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. Also,
inflammati