FLUOCINOLONE ACETONIDE oil

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Glenmark Pharmaceuticals Inc., USA

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil). Fluocinolone acetonide topical 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 (see PRECAUTIONS section).

Produktbesonderheiten:

Fluocinolone Acetonide Topical Oil, 0.01% is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 68462-590-89). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store at 20ºC to 25ºC (68° to 77°F); excursions permitted to 15ºC to 30ºC (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 November 2018

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
GLENMARK PHARMACEUTICALS INC., USA
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FLUOCINOLONE ACETONIDE
TOPICAL OIL, 0.01%
(SCALP OIL)
RX ONLY
For Topical Use Only-
Not for Oral, Ophthalmic, or Intravaginal Use
DESCRIPTION
Fluocinolone Acetonide Topical Oil, 0.01% contains 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, a synthetic corticosteroid for topical dermatologic
use. This
formulation is also marketed as Fluocinolone Acetonide Topical Oil,
0.01%, fluocinolone
acetonide for use as body oil for atopic dermatitis in adults and for
moderate to severe
atopic dermatitis in pediatric patients 2 years and older and as
fluocinolone acetonide oil,
0.01% for chronic eczematous external otitis. Chemically, fluocinolone
acetonide, USP is
C
H
F O . It has the following structural formula:
Fluocinolone acetonide, USP in Fluocinolone Acetonide Topical Oil,
0.01% has a molecular
weight of 452.49. It is a white to almost white, crystalline powder
and melts at about
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 Topical Oil, 0.01% contains
approximately 0.11 mg of
fluocinolone acetonide, USP in a blend of oils, which contains
anhydrous citric acid,
isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and
refined peanut oil.
Each packaged product contains 2 shower caps. The shower cap is made
of low density
polyethylene material with rubber elastic.
24
30 2
6
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