HALOG- halcinonide cream cream

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

HALCINONIDE (UNII: SI86V6QNEG) (HALCINONIDE - UNII:SI86V6QNEG)

Saatavilla:

Sun Pharmaceutical Industries, Inc.

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

HALOG (Halcinonide Cream, USP) 0.1% 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 preparations.

Tuoteyhteenveto:

HALOG ® (Halcinonide Cream, USP) 0.1% is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is supplied as:

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

HALOG- HALCINONIDE CREAM CREAM
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HALOG
(HALCINONIDE CREAM, USP) 0.1%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents. The steroids in this class include
halcinonide. Halcinonide, USP is designated
chemically as 21-Chloro-9-fluoro-11β, 16α,
17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal
with acetone. Graphic formula:
Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg
halcinonide, USP in a specially
formulated cream base consisting of cetyl alcohol, dimethicone 350,
glyceryl monostearate, isopropyl
palmitate, polysorbate 60, propylene glycol, purified water, and
titanium dioxide.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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 admi