FLUOCINOLONE ACETONIDE solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Sẵn có từ:

Lupin Pharmaceuticals,Inc.

INN (Tên quốc tế):

FLUOCINOLONE ACETONIDE

Thành phần:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Tóm tắt sản phẩm:

Fluocinolone Acetonide Topical Solution USP, 0.01% 60 cc Bottle with applicator tip – NDC 43386-069-60 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0690600202 Rev. 06/2017

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
LUPIN PHARMACEUTICALS,INC.
----------
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Topical Solution USP, 0.01% 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 Topical Solution USP, 0.01% contains
fluocinolone acetonide 0.1 mg/mL in a
water washable base of citric acid and propylene glycol.
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.
Inflammation and/or other disease
processes in the skin increase percutaneous absorption. Occlusive
dressings substantially increase the
percutaneous absorption of topical corticosteroids. Thus, occlusive
dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE
AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroids are metabolized primarily in the
liver and are