PERICHLOR MOUTHWASH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORHEXIDINE GLUCONATE

Available from:

PENDOPHARM DIVISION OF 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:

2018-09-04

Summary of Product characteristics

_ _
_PERICHLOR and PERICHLOR WITHOUT ALCOHOL-Product Monograph _
_Page 1 of 14_
PRODUCT MONOGRAPH
PR
PERICHLOR
®
PR
PERICHLOR
®
WITHOUT ALCOHOL
Chlorhexidine Gluconate Mouthwash
0.12%
BP
ANTIGINGIVITIS ORAL RINSE
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
October 10, 2019
PERICHLOR
®
is a registered trademark of Pharmascience Inc.
Submission Control No: 223243
_ _
_PERICHLOR and PERICHLOR WITHOUT ALCOHOL-Product Monograph _
_Page 2 of 14_
PR
PERICHLOR
®
PR
PERICHLOR
® WITHOUT ALCOHOL
Chlorhexidine Gluconate Mouthwash
0.12%
BP
ACTIONS, CLINICAL PHARMACOLOGY
PERICHLOR and PERICHLOR WITHOUT ALCOHOL (0.12% Chlorhexidine
Gluconate Mouthwash) provide 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 PERICHLOR and PERICHLOR
WITHOUT
ALCOHOL inhibits the buildup and maturation of plaque by reducing
certain microbes
regarded as gingival pathogens, thereby reducing gingivitis
1,4,5
. Chlorhexidine Gluconate
Mouthwash 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 Mouthwash for six months. Three
months after
Chlorhexidine Gluconate Mouthwash 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 glucona