HALCINONIDE cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Glasshouse Pharmaceuticals Limited Canada

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Halcinonide Cream USP, 0.1% is supplied as: NDC 71428-011-30 Tubes containing 30 g of cream NDC 71428-011-60 Tubes containing 60 g of cream Store at room temperature; avoid excessive heat (104° F).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HALCINONIDE- HALCINONIDE CREAM
GLASSHOUSE PHARMACEUTICALS LIMITED CANADA
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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 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 Halcinonide Cream USP, 0.1% contains 1 mg halcinonide in
a specially
formulated cream base consisting of cetyl alcohol, dimethicone 350,
mono and
diglycerides, 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 administered
corticosteroi