CHLORHEXIDINE MOUTHWASH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

BAJAJ MEDICAL, LLC

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:

2000-06-06

Summary of Product characteristics

- 1 -
PRODUCT MONOGRAPH
PR
CHLORHEXIDINE
CHLORHEXIDINE GLUCONATE ORAL RINSE USP
0.12%
ANTIGINGIVITIS
Manufactured By:
Bajaj Medical, LLC
415 W Pershing Road
Chicago, Illinois
60609-2760, USA
DATE OF REVISION:
Imported By: February 19, 2021
Quality & Compliance Services Inc.
2000 Argentia Road, Plaza 2, Suite 220
Mississauga, ON
L5N 1V8, Canada
SUBMISSION CONTROL NUMBER: 247515
- 2 -
PRODUCT MONOGRAPH
Pr
CHLORHEXIDINE
Chlorhexidine Gluconate Oral Rinse USP
0.12%
ACTIONS, CLINICAL PHARMACOLOGY:
Chlorhexidine gluconate oral rinse 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 six months’ clinical
use. Rinsing with chlorhexidine gluconate oral rinse inhibits the
buildup and maturation of plaque
by reducing certain microbes regarded as gingival pathogens, thereby
reducing gingivitis
1,4,5
.
Chlorhexidine gluconate oral rinse 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
chlorhexidine gluconate oral rinse for six months. Three months after
chlorhexidine gluconate
oral rinse use was discontinued, 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 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:
CHLORHEXIDINE (Chlorhexidine Gluconate) Oral Rinse USP is indicated
for use as part of a
professional progra