DIPROLENE LOTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

Available from:

MERCK CANADA INC

ATC code:

D07AC01

INN (International Name):

BETAMETHASONE

Dosage:

0.05%

Pharmaceutical form:

LOTION

Composition:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.05%

Administration route:

TOPICAL

Units in package:

30/60

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-11-01

Summary of Product characteristics

PRODUCT MONOGRAPH
DIPROLENE
®
Glycol OINTMENT/CREAM/LOTION
(betamethasone dipropionate USP 0.05% W/W)
Topical Corticosteroid
MERCK CANADA INC.
DATE OF REVISION:
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
September 4, 2014
http://www.merck.ca
Control: 174892
®
Registered trademark of Schering-Plough Canada Inc. Used under
license.
* All other trademarks are the property of their respective owner(s).
© 2011, 2014 Merck Canada Inc., a subsidiary of MERCK & CO., INC. All
rights reserved.
2
PRODUCT MONOGRAPH
NAME OF DRUG
DIPROLENE
®
Glycol Ointment/Cream/Lotion
Betamethasone Dipropionate USP 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
The lotion contains isopropyl alcohol and may cause stinging or
burning upon application to abraded
or sun-burned skin.
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