DERMA-SMOOTHE/FS- fluocinolone acetonide oil

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Royal Pharmaceuticals

INN (Tarptautinis Pavadinimas):

fluocinolone acetonide

Sudėtis:

fluocinolone acetonide 0.11 mg in 1 mL

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Derma-Smoothe/FS® 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). Derma-Smoothe/FS® may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis. Derma-Smoothe/FS® 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. Derma-Smoothe/FS® 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. Derma-Smoothe/FS® 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 (ppm). Physicians should use caution in prescribing Derma-Smoothe/FS® for peanut sensitive individuals.

Produkto santrauka:

Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 68791-102-04 ). 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: Hill Dermaceuticals, Inc.® Sanford, FL 32773 1.800.344.5707 For: Royal Pharmaceuticals, Inc Manasquan, NJ 08736 1.800.510.3401 Rev. CODE 171A239-1 Date: 1/2014

Autorizacija statusas:

New Drug Application

Prekės savybės

DERMA-SMOOTHE/FS- FLUOCINOLONE ACETONIDE OIL
ROYAL PHARMACEUTICALS
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DERMA-SMOOTHE/FS
FLUOCINOLONE ACETONIDE 0.01% TOPICAL OIL
(SCALP OIL)
For Topical Use Only-
Not for Oral, Ophthalmic, or Intravaginal Use
68791-102-04
DESCRIPTION
Derma-Smoothe/FSTopical
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. This formulation is also marketed as
Derma-Smoothe/FS 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 is C
H
F O . It has the following structural formula:
Fluocinolone acetonide in Derma-Smoothe/FS 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 Derma-Smoothe/FS 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 .
®
®
®
24
30 2
6
®
®
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
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 p