HALCINONIDE cream

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mylan Pharmaceuticals Inc.

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Halcinonide cream, 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.

Toote kokkuvõte:

Halcinonide Cream, USP 0.1% contains halcinonide, USP. The white to off-white cream is available as follows: NDC 0378-8056-49 carton containing one 30 g tube NDC 0378-8056-60 carton containing one 60 g tube Storage: Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.] Avoid excessive heat (104°F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A. 141101-0819 Revised: 8/2019 DPT:HALCCR:R2

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

HALCINONIDE- HALCINONIDE CREAM
MYLAN PHARMACEUTICALS INC.
----------
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:
C
H C1FO MW 4 54 .96
Each gram of 0.1% halcinonide cream, USP contains 1 mg halcinonide,
USP in a specially formulated
cream base consisting of cetyl alcohol, dimethicone 360, glyceryl
stearate, isopropyl palmitate,
nitrogen, 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 corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroi