DIPROLENE CREAM

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

Disponible desde:

MERCK CANADA INC

Código ATC:

D07AC01

Designación común internacional (DCI):

BETAMETHASONE

Dosis:

0.05%

formulario farmacéutico:

CREAM

Composición:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.05%

Vía de administración:

TOPICAL

Unidades en paquete:

15/50GM

tipo de receta:

Prescription

Área terapéutica:

ANTI-INFLAMMATORY AGENTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2019-06-28

Ficha técnica

PRODUCT MONOGRAPH
DIPROLENE
®
Glycol OINTMENT/CREAM
(betamethasone dipropionate 0.05% W/W)
Topical Corticosteroid
MERCK CANADA INC.
DATE OF REVISION:
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
March 21, 2019
www.merck.ca
Control: 223941
®
Schering-Plough Canada Inc. Used under license.
* All other trademarks are the property of their respective owner(s).
© 2011, 2019 Merck Canada Inc., a subsidiary of MERCK & CO., INC. All
rights reserved.
2
PRODUCT MONOGRAPH
NAME OF DRUG
DIPROLENE
®
Glycol Ointment/Cream
Betamethasone Dipropionate 0.05% W/W
PHARMACOLOGICAL CLASSIFICATION
Topical corticosteroid
ACTIONS
DIPROLENE
®
Glycol
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
®
Glycol is indicated for the relief of the inflammatory manifestations
of resistant or
severe psoriasis and corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
DIPROLENE
®
Glycol 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
®
Glycol 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 shoul