FLAC OTIC OIL- fluocinolone acetonide oil

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Patrin Pharma, Inc.

administration_route:

AURICULAR (OTIC)

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 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).

leaflet_short:

Flac® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 39328-079-20) 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]. CAUTION: Rx only Manufactured for: Patrin Pharma Inc, Skokie, IL 60076 1 [phone] Oct 2017

authorization_status:

Abbreviated New Drug Application

SPC

FLAC OTIC OIL- FLUOCINOLONE ACETONIDE OIL
PATRIN PHARMA, INC.
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FLAC® OTIC OIL
(FLUOCINOLONE ACETONIDE OIL, 0.01%)
EAR DROPS
FOR OTIC USE ONLY-
NOT FOR OPHTHALMIC USE NDC 39328-079-20
DESCRIPTION
FLAC OIL 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 oil (body oil) for
the treatment of atopic dermatitis and fluocinolone acetonide oil
(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% 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% 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 A2
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 A2.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the