FLUOCINOLONE ACETONIDE solution/ drops

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Padagis Israel Pharmaceuticals Ltd

INN (الاسم الدولي):

FLUOCINOLONE ACETONIDE

تركيب:

FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL

طريقة التعاطي:

AURICULAR (OTIC)

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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).

ملخص المنتج:

Fluocinolone Acetonide Oil, 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC 45802-009 -10). 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] CAUTION: Rx only Manufactured By Padagis Yeruham, Israel Distributed By PadagisTM Allegan, MI 49010 • www.padagis.com Rev 07-22 0N300 RC J3

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION/ DROPS
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
FLUOCINOLONE ACETONIDE OIL, 0.01% EAR DROPS
For Otic Use Only-
Not for Ophthalmic Use
NDC 45802-009-10
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 the scalp. 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 and refined peanut oil
NF.
CLINICAL PHARMACOLOGY
24
30 2
6
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 ex