LOCACORTEN VIOFORM CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLIOQUINOL; FLUMETHASONE PIVALATE

Available from:

PALADIN LABS INC.

ATC code:

D07CB05

INN (International Name):

FLUMETASONE AND ANTIBIOTICS

Dosage:

3%; 0.02%

Pharmaceutical form:

CREAM

Composition:

CLIOQUINOL 3%; FLUMETHASONE PIVALATE 0.02%

Administration route:

TOPICAL

Units in package:

50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0204579001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-03-01

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
LOCACORTEN
® VIOFORM
®
(FLUMETHASONE PIVALATE 0.02% - CLIOQUINOL 3%)
CREAM
Topical Corticosteroid with Antibacterial - Antifungal Agent
Paladin Labs Inc.
Date of Preparation:
6111 Royalmount Ave., suite 102
June 9, 2009
Montréal, Québec
H4P 2T4
Control # 130473
Pr
LOCACORTEN
®
and VIOFORM
®
are registered trademarks of Novartis Pharmaceuticals
Canada Inc.
- 2 -
PRESCRIBING INFORMATION
PR
LOCACORTEN
® VIOFORM
®
(flumethasone pivalate 0.02% - clioquinol 3%)
Cream
Topical Corticosteroid with Antibacterial-Antifungal Agent
ACTIONS AND CLINICAL PHARMACOLOGY
LOCACORTEN (flumethasone pivalate) is a moderately potent
difluorinated corticosteroid ester
with anti-inflammatory, antipruritic and vasoconstrictive properties.
As it is a pivalate, its
anti-inflammatory action is concentrated at the site of application.
This local effect on diseased
areas results in a prompt decrease in inflammation, exudation and
itching.
VIOFORM
(clioquinol),
the
antimicrobial
component
of
LOCACORTEN VIOFORM
(flumethasone
pivalate/clioquinol),
is
active
against
a
broad
spectrum
of
pathogenic
microorganisms, including fungi (e.g., Candida, Microsporum,
Trichophyton) and gram-positive
bacteria (e.g., Staphylococci). Clioquinol has only a slight
inhibitory effect on gram-negative
bacteria. Clioquinol exerts a bacteriostatic, rather than a
bactericidal action.
LOCACORTEN VIOFORM combines the antifungal and antibacterial effects
of clioquinol with
the anti-inflammatory and antipruritic effects of flumethasone.
INDICATIONS AND CLINICAL USE
LOCACORTEN VIOFORM (flumethasone pivalate/clioquinol) is indicated in
the initial treatment
of corticosteroid-responsive inflammatory skin disorders complicated
by bacterial and/or fungal
infections, with appropriate systemic antibiotics if necessary, such
as: seborrheic dermatitis,
atopic dermatitis, localized neurodermatitis, contact dermatitis,
intertrigo, superficial forms of
pyoderma (e.g., impetigo) and of dermatomycosis in which acute
inflammation is a prominent
feature.
T