FLUOCINOLONE ACETONIDE cream

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Fluocinolone Acetonide (UNII: 0CD5FD6S2M) (Fluocinolone Acetonide - UNII:0CD5FD6S2M)

থেকে পাওয়া:

Teligent Pharma, Inc.

INN (International Name):

Fluocinolone Acetonide

রচনা:

Fluocinolone Acetonide 0.1 mg in 1 g

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

পণ্য সারাংশ:

Fluocinolone Acetonide Cream USP, 0.01% is supplied in Fluocinolone Acetonide Cream USP, 0.025% is supplied in Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

অনুমোদন অবস্থা:

New Drug Application Authorized Generic

পণ্য বৈশিষ্ট্য

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE CREAM
TELIGENT PHARMA, INC.
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FLUOCINOLONE ACETONIDE
CREAM USP, 0.01%, 0.025%
FOR INITIATION OF THERAPY IN INFLAMMATORY DERMATOSES.
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Cream USP is intended for topical
administration. The active component is the
corticosteroid fluocinolone acetonide, which has the chemical name
pregna-1,4-diene-3,20-dione,6,9-
difluoro-11,21-dihydroxy-16, 17-[(1-methylethylidene)bis
(oxy)]-,(6α,11β,16α)-. It has the following
chemical structure:
Fluocinolone Acetonide Cream USP 0.01% contains fluocinolone acetonide
0.1 mg/g in a water-
washable aqueous base of butylated hydroxytoluene, cetyl alcohol,
citric acid, edetate disodium,
methylparaben and propylparaben (preservatives), mineral oil, polyoxyl
20 cetostearyl ether, propylene
glycol, simethicone, stearyl alcohol, water (purified) and white wax.
Fluocinolone Acetonide Cream USP 0.025% contains fluocinolone
acetonide 0.25 mg/g in a water-
washable aqueous base of butylated hydroxytoluene, cetyl alcohol,
citric acid, edetate disodium,
methylparaben and propylparaben (preservatives), mineral oil, polyoxyl
20 cetostearyl ether, propylene
glycol, simethicone, stearyl alcohol, water (purified) and white wax.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear. Various
laboratory methods, including vasoconstrictor assays, are used to
compare and predict potencies and/or
clinical efficacies of the topical corticosteroids. There is some
evidence to suggest that a
recognizable correlation exists between vasoconstrictor potency and
therapeutic efficacy in man.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the vehicle, the integrity of the epidermal barrier, and the
use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin.
Inflammati