DENTICARE CHLORHEXIDINE GLUCONATE ORAL RINSE 0.12% MOUTHWASH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

AMD MEDICOM 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:

500ML/4L

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTI-INFECTIVES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

1999-06-29

Summary of Product characteristics

DentiCare™ Chlorhexidine Gluconate Oral Rinse 0.12% Product
Monograph
Page 1 of 10
PRODUCT MONOGRAPH
PR
DENTICARE
™ CHLORHEXIDINE GLUCONATE ORAL RINSE 0.12%
CHLORHEXIDINE GLUCONATE
0.12%
ORAL RINSE
ANTIGINGIVITIS ORAL RINSE
AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montréal, Québec
Canada, H9P 2Z2
www.medicom.ca
Submission Control No: 223628
Date of Preparation:
March 28, 2019
DentiCare™ Chlorhexidine Gluconate Oral Rinse 0.12% Product
Monograph
Page 2 of 10
PRODUCT MONOGRAPH
DENTICARE CHLORHEXIDINE GLUCONATE ORAL RINSE 0.12%
0.12% Chlorhexidine Gluconate
THERAPEUTIC CLASSIFICATION
Antigingivitis Oral Rinse
ACTION AND CLINICAL PHARMACOLOGY
DentiCare Chlorhexidine Gluconate Oral Rinse 0.12% 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
through six months’ clinical use
of 0.12% chlorhexidine gluconate oral rinse. Rinsing with 0.12%
chlorhexidine gluconate oral rinse
inhibits the build-up and maturation of plaque by reducing certain
microbes regarded as gingival
pathogens,
thereby
reducing
gingivitis.
0.12%
chlorhexidine
gluconate
oral
rinse
provides
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 a 0.12%
chlorhexidine gluconate
oral rinse for six months. Three months after discontinued use, the
number of bacteria in plaque
had returned to pretreatment 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 in the gastrointestinal tract.
Excretion of chlorhexidine gluconate occurred primarily through the
feces (approximately 90%).
Less than 1% of the chlorhexidine gluconate ing