FLUOCINOLONE ACETONIDE oil

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Quagen Pharmaceuticals LLC

Administreringsrute:

AURICULAR (OTIC)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 oppsummering:

Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in a 1 fluid ounce bottle containing 20 mL net content (Dropper Included). (NDC # 70752-159-20). Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. Discard fluocinolone acetonide oil, 0.01% (ear drops) 2 months after initial use. CAUTION: Rx only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52027 Rev. 04/21

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
QUAGEN 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. This
formulation is also marketed as fluocinolone acetonide topical oil,
0.01% (body oil) for
the treatment of atopic dermatitis and fluocinolone acetonide topical
oil, 0.01% (scalp oil)
for the treatment of psoriasis of scalp. Chemically, fluocinolone
acetonide is C
H
F O .
It has the following structural formula:
Fluocinolone acetonide 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 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
24
30 2
6
2
membrane phospholipids by phospholipase A .
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is
determined by many