FLUOCINOLONE ACETONIDE oil

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

Dostupné z:

Glenmark Pharmaceuticals Inc., USA

Spôsob podávania:

AURICULAR (OTIC)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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).

Prehľad produktov:

Fluocinolone Acetonide Oil, 0.01% (Ear Drops) is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 68462-185-56). 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]. CAUTION: Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa October 2018

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
GLENMARK PHARMACEUTICALS INC., USA
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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, USP {(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, USP
is C
H F O . It has the following structural formula:
Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear
Drops) has a molecular
weight of 452.49. It is a white or almost white, crystalline powder
and melts at 270°C with
decomposition; practically insoluble in water and heptane, soluble in
methanol, anhydrous ethanol and
acetone, slightly soluble in ether and chloroform.
Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains
approximately 0.11 mg of
fluocinolone acetonide, USP 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 penetra