LOCOID- hydrocortisone butyrate cream

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

MAH:

Bausch Health US, LLC

INN:

HYDROCORTISONE BUTYRATE

composition:

HYDROCORTISONE BUTYRATE 1 mg in 1 g

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

LOCOID (hydrocortisone butyrate) cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. None.

leaflet_short:

LOCOID® (hydrocortisone butyrate) cream, 0.1% is supplied in tubes containing:                 NDC 16781-382-15 15 g tube                 NDC 16781-382-45 45 g tube

authorization_status:

New Drug Application

SPC

LOCOID- HYDROCORTISONE BUTYRATE CREAM
BAUSCH HEALTH US, LLC
----------
LOCOID
(HYDROCORTISONE BUTYRATE) CREAM, 0.1%
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
LOCOID (hydrocortisone butyrate) cream, 0.1% contains the topical
corticosteroid,
hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It
has the chemical
name: 11ß,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the
molecular formula:
C
H
O ; the molecular weight: 432.54; and the CAS registry number:
13609-67-1.
Its structural formula is:
Each gram of LOCOID cream contains 1 mg of hydrocortisone butyrate in
a hydrophilic
base consisting of anhydrous citric acid, ceteth-20, cetostearyl
alcohol, light mineral oil,
propylparaben and butylparaben (preservatives), purified water, sodium
citrate, and
white petrolatum.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic, and
vasoconstrictive
actions. The mechanism of anti-inflammatory activity of topical
corticosteroids is unclear.
Various laboratory methods, including vasoconstrictor assays, are used
to compare and
predict potencies and/or clinical efficacies of topical
corticosteroids. There is some
evidence to suggest that a recognizable correlation exists between
vasoconstrictor
potency and therapeutic efficacy in man.
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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.
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 i