FLUOCINOLONE ACETONIDE oil

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

VersaPharm Inc. - an Akorn Company

INN (International namn):

FLUOCINOLONE ACETONIDE

Sammansättning:

FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL

Administreringssätt:

AURICULAR (OTIC)

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Fluocinolone Acetonide Oil, 0.01% Ear Drops 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 ).

Produktsammanfattning:

Fluocinolone Acetonide Oil, 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC 61748-250-20). Keep tightly closed. Store upright at 20° to 25°C (68 to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact VersaPharm Inc. at 1-877-254-4381 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION: Rx only Manufactured by: Ei LLC   Kannapolis, NC 28083 Marketed by: VersaPharm Inc. – An Akorn Company Lake Forest, IL 60045 FLUE00N Revised: 10-2016

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
VERSAPHARM INC. - AN AKORN COMPANY
----------
FLUOCINOLONE ACETONIDE OIL, 0.01% EAR DROPS
Rx only
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 . It has the following structural formula:
Fluocinolone acetonide in Fluocinolone Acetonide Oil, 0.01% Ear Drops
has a molecular weight of
452.50. 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% Ear Drops contains
approximately 0.11 mg of
fluocinolone acetonide in a blend of oils, which contains isopropyl
alcohol, isopropyl myristate, light
mineral oil, oleth-2, refined peanut oil NF and fragrances.
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
24
30
2
6
2
2
including the vehicle and the integrity of the epidermal barrier.
Occlusion of topical corticosteroids
can enhance penetration. Topical corticoster