LOCOID hydrocortisone butyrate ointment

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Onset Dermatologics, LLC

INN (International Nazwa):

HYDROCORTISONE BUTYRATE

Skład:

HYDROCORTISONE BUTYRATE 1 mg in 1 g

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

New Drug Application

Charakterystyka produktu

LOCOID- HYDROCORTISONE BUTYRATE OINTMENT
ONSET DERMATOLOGICS, LLC
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LOCOID
(HYDROCORTISONE BUTYRATE) OINTMENT, 0.1%
FOR TOPICAL USE
DESCRIPTION
Locoid
(hydrocortisone butyrate) Ointment, 0.1% contains the topical
corticosteroid, hydrocortisone
butyrate, a non-fluorinated 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 gram of Locoid
Ointment contains 1 mg of hydrocortisone butyrate in a base consisting
of
mineral oil and polyethylene.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic 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.
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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
liver and are then excreted by the
kidneys. Some of the topical corticosteroids and their metabolites are
also excreted into the bile.
INDICATIONS AND U