PMS-METRONIDAZOLE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-04-2018
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Active ingredient:
METRONIDAZOLE
Available from:
PHARMASCIENCE INC
ATC code:
J01XD01
INN (International Name):
METRONIDAZOLE
Dosage:
500MG
Pharmaceutical form:
CAPSULE
Composition:
METRONIDAZOLE 500MG
Administration route:
ORAL
Units in package:
8/14/100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTIPROTOZOALS
Product summary:
Active ingredient group (AIG) number: 0102572003; AHFS:
Authorization status:
APPROVED
Authorization date:
2006-08-31
Summary of Product characteristics
PRESCRIBING INFORMATION
PR
PMS-METRONIDAZOLE
Metronidazole Capsules, House Standard
500 mg
ANTIBACTERIAL - ANTIPROTOZOAL
PHARMASCIENCE INC.
Date of Revision:
April 13, 2018
6111 Royalmount Ave, Suite #100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Control No. 214759
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PRESCRIBING INFORMATION
PR
PMS-METRONIDAZOLE
Metronidazole Capsules, House Standard
500 mg
THERAPEUTIC CLASSIFICATION
Antibacterial - Antiprotozoal
ACTION AND CLINICAL PHARMACOLOGY
pms-METRONIDAZOLE (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 USE
PMS-METRONIDAZOLE METRONIDAZOLE) IS INDICATED FOR THE TREATMENT OF:
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 pms-METRONIDAZOLE capsules at the
discretion of the physician.
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