MAR-METRONIDAZOLE CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

METRONIDAZOLE

から入手可能:

MARCAN PHARMACEUTICALS INC

ATCコード:

P01AB01

INN（国際名）:

METRONIDAZOLE

投薬量:

500MG

医薬品形態:

CAPSULE

構図:

METRONIDAZOLE 500MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTIPROTOZOALS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2019-08-07

製品の特徴

_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
MAR-METRONIDAZOLE
(Metronidazole Capsules)
Manufacturer’s Standard
500 mg Capsules
Antibacterial - Antiprotozoal
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Preparation:
August 06, 2019
Submission Control No. 215186
_Page 2 of 31 _
PRODUCT MONOGRAPH
PR
MAR-METRONIDAZOLE
(Metronidazole Capsules)
Manufacturer’s Standard
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 MAR-METRONIDAZOLE 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