FLUOCINOLONE ACETONIDE oil

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Seton Pharmaceuticals

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) 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 0.01% Topical Oil 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 0.01% Topical Oil 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 0.01% Topical Oil 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 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% Topical Oil 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% Topical Oil for peanut sensitive individuals.

Ürün özeti:

Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) is supplied in bottles containing 4 fluid ounces. It is labeled as Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) (NDC # 13925-507-04 ). Fluocinolone Acetonide 0.01% Topical Oil (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: Hill Dermaceuticals, Inc. Sanford, Florida 32773 FOR: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Code: 171G244-1 Date: 01/2014

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
SETON PHARMACEUTICALS
----------
FLUOCINOLONE ACETONIDE 0.01% TOPICAL OIL
(SCALP OIL)
For Dermatologic Use Only- NDC 13925-507-04
Not for Oral, Ophthalmic, or Intravaginal Use-
DESCRIPTION
Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) 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 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% Topical Oil contains
approximately 0.11 mg
of fluocinolone acetonide in a blend of oils which contain isopropyl
alcohol, isopropyl
myristate, light mineral oil, oleth-2, refined peanut oil NF and
fragrances.
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,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
activity of the topical steroids, in general, is unclear. However,
corticosteroids are
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 i