FLAGYL CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

METRONIDAZOLE

Commercializzato da:

SANOFI-AVENTIS CANADA INC

Codice ATC:

P01AB01

INN (Nome Internazionale):

METRONIDAZOLE

Dosaggio:

500MG

Forma farmaceutica:

CAPSULE

Composizione:

METRONIDAZOLE 500MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTIPROTOZOALS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2017-07-06

Scheda tecnica

_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