DERMOTIC- fluocinolone acetonide oil

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Royal Pharmaceuticals

INN (Medzinárodný Name):

fluocinolone acetonide

Zloženie:

fluocinolone acetonide 0.11 mg in 1 mL

Spôsob podávania:

AURICULAR (OTIC)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

DermOtic® 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).

Prehľad produktov:

DermOtic® Oil (fluocinolone acetonide oil) 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net content (Dropper Included) (NDC # 68791-103-20). 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]. ​Discard DermOtic Oil 2 months after initial use. 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

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

DERMOTIC- FLUOCINOLONE ACETONIDE OIL
ROYAL PHARMACEUTICALS
----------
DERMOTIC OIL
(FLUOCINOLONE ACETONIDE OIL) 0.01%
EAR DROPS
For Otic Use Only-
Not for Ophthalmic Use
NDC 68791-103-20
DESCRIPTION
DermOtic
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. This
formulation is also
marketed as Derma-Smoothe/FS Body Oil for the treatment of atopic
dermatitis and
Derma-Smoothe/FS Scalp Oil for the treatment of psoriasis of the
scalp. Chemically,
fluocinolone acetonide is C
H
F O . It has the following structural formula:
®
®
®
®
24
30
2
6
®
Fluocinolone acetonide in DermOtic
Oil 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 DermOtic
Oil 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
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