X-PUR CHLORHEXIDINE MOUTHWASH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

PHARMASCIENCE INC

ATC code:

A01AB03

INN (International Name):

CHLORHEXIDINE

Dosage:

0.12%

Pharmaceutical form:

MOUTHWASH

Composition:

CHLORHEXIDINE GLUCONATE 0.12%

Administration route:

BUCCAL

Units in package:

475ML

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTI-INFECTIVES

Product summary:

Active ingredient group (AIG) number: 0107629007; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-09-26

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
X-PUR
® CHLORHEXIDINE
Chlorhexidine Gluconate Oral Rinse
0.12%
ANTIGINGIVITIS ORAL RINSE
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Canada
H4P 2T4
Date of Revision:
June 4, 2013
Control No: 164331
PR
® Registered trademark of Oral Science Inc., used under license by
Pharmascience Inc.
_ _
_X-PUR CHLORHEXIDINE Product Monograph _
_Page 2 of 14_
PR
X-PUR CHLORHEXIDINE
CHLORHEXIDINE GLUCONATE ORAL RINSE
0.12%
ACTIONS, CLINICAL PHARMACOLOGY:
X-PUR CHLORHEXIDINE Oral Rinse (0.12% Chlorhexidine Gluconate)
provides
antimicrobial activity during oral rinsing which is maintained between
rinsings.
Microbiologic sampling of plaque has shown a general reduction of both
aerobic and
anaerobic bacterial counts ranging from 54-97% through 6 months’
clinical use. Rinsing
with X-PUR CHLORHEXIDINE inhibits the buildup and maturation of plaque
by
reducing certain microbes regarded as gingival pathogens, thereby
reducing gingivitis
1,4,5
.
X-PUR CHLORHEXIDINE provided antimicrobial activity during rinsing and
for
several hours thereafter.
No significant changes in bacterial sensitivity, overgrowth of
potentially opportunistic
organisms or other adverse changes in the oral microbial flora were
observed following
the use of X-PUR CHLORHEXIDINE for 6 months. Three months after X-PUR
CHLORHEXIDINE use was discontinued, the number of bacteria in plaque
had returned
to pre-treatment levels and sensitivity of plaque bacteria to
chlorhexidine gluconate
remained unchanged.
Studies conducted with human subjects and animals demonstrate that any
ingested
chlorhexidine gluconate is poorly absorbed from the gastrointestinal
tract. Excretion of
chlorhexidine gluconate occurred primarily through the feces
(approximately 90%). Less
than 1% of the chlorhexidine gluconate ingested by these subjects was
excreted in the
urine.
INDICATIONS AND CLINICAL USE:
X-PUR CHLORHEXIDINE (0.12% chlorhexidine gluconate) is indicated for
use as part
of a professional program for the treatment of moderate to severe
gingivitis,