FLAGYL CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METRONIDAZOLE

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

P01AB01

INN (International Name):

METRONIDAZOLE

Dosage:

500MG

Pharmaceutical form:

CAPSULE

Composition:

METRONIDAZOLE 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIPROTOZOALS

Product summary:

Active ingredient group (AIG) number: 0102572003; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-07-06

Summary of Product characteristics

_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
FLAGYL
®
(Metronidazole Capsules)
500 mg Capsules
_ _
_ _
Antibacterial - Antiprotozoal
sanofi-aventis Canada Inc.
1755 Steeles Avenue West
Toronto, ON
M2R 3T4
Date of Initial Authorization:
May 24, 2023
Submission Control No. 274887
_Page 2 of 31 _
PRODUCT MONOGRAPH
PR
FLAGYL
®
(metronidazole capsules)
500 mg Capsules
THERAPEUTIC CLASSIFICATION
Antibacterial - Antiprotozoal
ACTION AND CLINICAL PHARMACOLOGY
Metronidazole is bactericidal against anaerobic bacteria; it exerts
trichomonacidal activity and is
also active against _Giardia lamblia_ and _Entamoeba histolytica_. Its
exact mechanism of action has
not been entirely determined as yet. It has been proposed that an
intermediate in the reduction of
metronidazole, produced only in anaerobic bacteria and protozoa is
bound to deoxyribonucleic
acid and electron-transport proteins, inhibits subsequent nucleic acid
synthesis.
INDICATIONS AND CLINICAL USES
PROTOZOAL INFECTIONS
-
Trichomonal infections in men as well as in women.
-
Hepatic and intestinal amebiasis.
-
Giardiasis.
BACTERIAL VAGINOSIS
The “1988 Canadian Guidelines for the Treatment of Sexually
Transmitted Diseases in
Neonates, Children, Adolescents and Adults” recommends metronidazole
for the treatment of
this condition.
BACTERIAL INFECTIONS
Treatment:
Metronidazole is indicated in the treatment of serious anaerobic
intra-abdominal infections due
to susceptible anaerobic bacteria, such as _Bacteroides fragilis_ (and
other species of Bacteroides),
_Clostridium_, _Fusobacterium_, _Peptococcus_, and _Peptostreptococcus
species_. In the treatment of
most serious anaerobic infections, intravenous metronidazole is
usually administered initially.
This may be followed by oral therapy with Flagyl capsules at the
discretion of the physician.
Culture and susceptibility studies should be performed to determine
the causative organisms and
their susceptibility to metronidazole. Based on clinical judgment and
anticipated bacteriological
_Page 3 of 31 _
findings, therapy may be