Land: Kanada
Sprache: Englisch
Quelle: Health Canada
METRONIDAZOLE
MARCAN PHARMACEUTICALS INC
P01AB01
METRONIDAZOLE
500MG
CAPSULE
METRONIDAZOLE 500MG
ORAL
100
Prescription
MISCELLANEOUS ANTIPROTOZOALS
Active ingredient group (AIG) number: 0102572003; AHFS:
APPROVED
2019-08-07
_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 Lesen Sie das vollständige Dokument