DIPROLENE OINTMENT

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

זמין מ:

ORGANON CANADA INC.

קוד ATC:

D07AC01

INN (שם בינלאומי):

BETAMETHASONE

כמות:

0.05%

טופס פרצבטיות:

OINTMENT

הרכב:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.05%

מסלול נתינה (של תרופות):

TOPICAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

ANTI-INFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0106299002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2011-03-02

מאפייני מוצר

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DIPROLENE
®
betamethasone dipropionate ointment, Organon Standard
0.05% W/W
Topical Corticosteroid
ORGANON CANADA INC.
Date of Initial Approval
16766 route Transcanadienne
January 07, 1985
Kirkland, Quebec
H9H 4M7
Date of Revision:
April 13, 2021
www.organon.ca
Control
#
:
249779
2
PRODUCT MONOGRAPH
NAME OF DRUG
DIPROLENE
®
betamethasone dipropionate ointment 0.05% W/W
PHARMACOLOGICAL CLASSIFICATION
Topical corticosteroid
ACTIONS
DIPROLENE
®
provides anti-inflammatory, antipruritic and vasoconstrictive effects.
The propylene
glycol components of the vehicle increase penetration and enhance the
local effectiveness of
betamethasone dipropionate.
INDICATIONS AND CLINICAL USES
DIPROLENE
®
is indicated for the relief of the inflammatory manifestations of
resistant or severe
psoriasis and corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
DIPROLENE
®
is contraindicated in viral diseases including vaccinia, varicella,
herpes simplex, and
fungal infections; also, tuberculosis of the skin. DIPROLENE
®
products are contraindicated in those
patients with a history of sensitivity reactions to betamethasone
dipropionate, other corticosteroids or
to any of the components of DIPROLENE
®
products.
WARNINGS
Do not use in or near the eyes since DIPROLENE
®
is not formulated for ophthalmic use. This product
should not be used under occlusive dressing.
3
Any of the side effects that are reported following systemic use of
corticosteroids, including adrenal
suppression, may also occur with topical corticosteroids, especially
in infants and children.
Pregnancy and lactation: Since safety of topical corticosteroid use in
pregnant women has not been
established, drugs of this class should be used during pregnancy only
if the potential benefit justifies
the potential risk to the fetus. Drugs of this class should not be
used extensively in large amounts or for
prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of
cortic