Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
METRONIDAZOLE
SANOFI-AVENTIS CANADA INC
P01AB01
METRONIDAZOLE
500MG
CAPSULE
METRONIDAZOLE 500MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTIPROTOZOALS
Active ingredient group (AIG) number: 0102572003; AHFS:
APPROVED
2017-07-06
_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 Baca dokumen lengkap