cortifoam- hydrocortisone acetate aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Schwarz Pharma

INN (International Name):

hydrocortisone acetate

Pharmaceutical form:

AEROSOL, FOAM

Composition:

90 mg in 900 mg

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Cortifoam® is supplied in an aerosol container with a special rectal applicator. Each applicator delivers approximately 900 mg of foam containing approximately 80 mg of hydrocortisone as 90 mg of hydrocortisone acetate. When used correctly, the aerosol container will deliver a minimum of 14 applications. NDC 0091-0695-2 15 g Store at controlled room temperature, 20°-25°C (68°-77°F). DO NOT REFRIGERATE. Rx Only

Summary of Product characteristics

CORTIFOAM- HYDROCORTISONE ACETATE AEROSOL, FOAM
SCHWARZ PHARMA
----------
CORTIFOAM®
(HYDROCORTISONE ACETATE RECTAL AEROSOL)
10% RECTAL FOAM
DES CRIPTION
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
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.
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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 temperatures above