CORTIFOAM hydrocortisone acetate aerosol

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

hydrocortisone acetate (UNII: 3X7931PO74) (hydrocortisone - UNII:WI4X0X7BPJ)

Dostopno od:

Alaven Pharmaceutical LLC

INN (mednarodno ime):

hydrocortisone acetate

Sestava:

hydrocortisone acetate 1500 mg in 15 g

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

New Drug Application

Lastnosti izdelka

CORTIFOAM - HYDROCORTISONE ACETATE AEROSOL, FOAM
ALAVEN PHARMACEUTICAL LLC
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CORTIFOAM
(HYDROCORTISONE ACETATE RECTAL AEROSOL)
10% RECTAL FOAM
DESCRIPTION
Cortifoam (hydrocortisone acetate rectal aerosol) 10% Rectal Foam
contains hydrocortisone acetate
10% in a base containing propylene glycol, emulsifying wax,
polyoxyethylene-10-stearyl ether, cetyl
alcohol, methylparaben, propylparaben, trolamine, purified water and
inert propellants: isobutane and
propane.
Each application delivers approximately 900 mg of foam containing 80
mg of hydrocortisone (90 mg of
hydrocortisone acetate).
The molecular weight of hydrocortisone acetate is 404.50. It is
designated chemically as pregn-4-ene-
3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)-. The empirical
formula is C
H O and the
structural formula is:
Hydrocortisone acetate, a synthetic adrenocortical steroid, is a white
to practically white, odorless,
crystalline powder. It is insoluble in water (1 mg/100 mL) and
slightly soluble in alcohol and
chloroform.
CLINICAL PHARMACOLOGY
Cortifoam provides effective topical administration of an
anti-inflammatory corticosteroid as
adjunctive therapy of ulcerative proctitis. Direct observations of
methylene blue-containing foam have
shown staining about 10 centimeters into the rectum.
INDICATIONS AND USAGE
®
®
23
32
6
®
Cortifoam is indicated as adjunctive therapy in the topical treatment
of ulcerative proctitis of the distal
portion of the rectum in patients who cannot retain hydrocortisone or
other corticosteroid enemas.
CONTRAINDICATIONS
Cortifoam is contraindicated in patients who are hypersensitive to any
components of this product.
Local contraindications to the use of intrarectal steroids include
obstruction, abscess, perforation,
peritonitis, fresh intestinal anastomoses, extensive fistulas and
sinus tracts.
WARNINGS
GENERAL
Do not insert any part of the aerosol container directly into the
anus. Contents of the container are under
pressure. Do not burn or puncture the aerosol container. Do not store
at temperatu