LOCOID- hydrocortisone butyrate solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Bausch Health US, LLC

INN (שם בינלאומי):

HYDROCORTISONE BUTYRATE

הרכב:

HYDROCORTISONE BUTYRATE 1 mg in 1 mL

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Locoid (hydrocortisone butyrate) Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis. None.

leaflet_short:

Locoid® (hydrocortisone butyrate) Solution, 0.1% is supplied in polyethylene bottles containing:           60 mL (NDC 16781-391-60)

מצב אישור:

New Drug Application

מאפייני מוצר

LOCOID- HYDROCORTISONE BUTYRATE SOLUTION
BAUSCH HEALTH US, LLC
----------
LOCOID (HYDROCORTISONE BUTYRATE) SOLUTION, 0.1%
FOR TOPICAL USE ONLY
DESCRIPTION
Locoid (hydrocortisone butyrate) Solution, 0.1% contains the topical
corticosteroid,
hydrocortisone butyrate, a nonfluorinated hydrocortisone ester. It has
the chemical
name: 11β,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 mL of Locoid Solution contains 1 mg of hydrocortisone butyrate in
a vehicle
consisting of anhydrous citric acid, glycerin, isopropyl alcohol (50%
v/v), povidone,
purified water, and sodium citrate.
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.
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
®
®
25
36
6
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 in the