FLUOCINOLONE ACETONIDE 0.01%- 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:

Seton Pharmaceuticals

INN:

fluocinolone acetonide

composition:

fluocinolone acetonide 0.11 mg in 1 mL

administration_route:

AURICULAR (OTIC)

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Fluocinolone acetonide 0.01% Oil 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). Pediatric Use: Fluocinolone acetonide 0.01% Oil Ear Drops may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis. Fluocinolone acetonide 0.01% Oil Ear Drops is not recommended for use on the face (See ADVERSE REACTION section). Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS). HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Fluocinolone acetonide 0.01% Oil Ear Drops is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million. Physicians should use caution in prescribing Fluocinolone acetonide 0.01% Oil Ear Drops for peanut-sensitive individuals.

leaflet_short:

Fluocinolone acetonide 0.01% Oil Ear Drops is supplied in a 1 fluid ounce bottle containing 20 mL net weight (Dropper Included). (NDC # 13925-508-20). 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

authorization_status:

New Drug Application Authorized Generic

SPC

FLUOCINOLONE ACETONIDE 0.01%- FLUOCINOLONE ACETONIDE OIL
SETON PHARMACEUTICALS
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FLUOCINOLONE ACETONIDE 0.01% OIL
EAR DROPS
For Otic Use Only NDC13925-508-20
Not for Ophthalmic Use
DESCRIPTION
Fluocinolone acetonide 0.01% 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.
Chemically, fluocinolone acetonide is C
H
F O . It has the following structural
formula:
Fluocinolone acetonide 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 0.01% Oil 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, refined peanut oil
NF, and fragrances.
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
24
30
2
6
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 en