CORTIFOAM- hydrocortisone acetate aerosol, foam

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Διαθέσιμο από:

Meda Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

HYDROCORTISONE ACETATE

Σύνθεση:

HYDROCORTISONE ACETATE 1500 mg in 15 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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 0037-6830-15    15 g Store at controlled room temperature, 20°-25°C (68°-77°F). DO NOT REFRIGERATE. Rx only Distributed by: Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 © 2022 Mylan Specialty L.P., a Viatris Company For Medical Inquiries, call toll-free 1-877-848-6608 CORTIFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. IN-683015-0X

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

CORTIFOAM- HYDROCORTISONE ACETATE AEROSOL, FOAM
MEDA PHARMACEUTICALS INC.
----------
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
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.
®
23
32
6
®
®
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 temperatures above 120°F. Because Cortifoam is not expelled,
systemic
hydroc