FLUOCINOLONE ACETONIDE OIL- fluocinolone acetonide oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 NF (see PRECAUTIONS section). Pediatric Use: Fluocinolone acetonide topical oil, 0.01% may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis.  Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area. Application to intertriginous areas should be avoided due to the increased possibility of local adverse events such as striae, atrophy, and telangiectasia, which may be irreversible. The smallest amount of drug needed to cover the affected areas should be applied. Long term safety in the pediatric population has not been established. Fluocinolone acetonide topical oil, 0.01% is not recommended for use on the face (see ADVERSE REACTIONS section). Because of a higher ratio of skin surface area to body mass, children are at

Product summary:

Fluocinolone Acetonide Topical Oil, 0.01% is supplied in bottles containing 4 fluid ounces.  It is labeled as Scalp Oil (NDC # 64980-330-04). Scalp Oil is supplied with 2 shower caps. Keep tightly closed.  Store at 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: Lyne Laboratories, Inc., Brockton, MA 02301 Manufactured for: Rising Pharmaceuticals, Inc., Saddle Brook, NJ 07663 R1-04/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE OIL- FLUOCINOLONE ACETONIDE OIL
RISING PHARMACEUTICALS, INC.
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FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL)
NDC 64980-330-04
FOR TOPICAL USE ONLY - NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE
DESCRIPTION
Fluocinolone Acetonide Topical Oil, 0.01% contains 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 for
topical dermatologic use. Chemically, fluocinolone acetonide is C
H
F O . It has the
following structural formula:
Fluocinolone acetonide in fluocinolone acetonide topical 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 topical 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.
Each packaged product contains 2 shower caps. The shower cap is made
of low density
polyethylene material with rubber elastic.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, fluocinolone acetonide has
anti-inflammatory,
24
30 2
6
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
corticosteroid