PYLERA CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BISMUTH OXIDE (BISMUTH SUBCITRATE POTASSIUM); TETRACYCLINE HYDROCHLORIDE; METRONIDAZOLE

Available from:

LABORATOIRES JUVISE PHARMACEUTICALS

ATC code:

A02BD08

INN (International Name):

BISMUTH SUBCITRATE,TETRACYCLINE AND METRONIDAZOLE

Dosage:

40MG; 125MG; 125MG

Pharmaceutical form:

CAPSULE

Composition:

BISMUTH OXIDE (BISMUTH SUBCITRATE POTASSIUM) 40MG; TETRACYCLINE HYDROCHLORIDE 125MG; METRONIDAZOLE 125MG

Administration route:

ORAL

Units in package:

120

Prescription type:

Prescription

Therapeutic area:

TETRACYCLINES

Product summary:

Active ingredient group (AIG) number: 0348802001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-02-01

Summary of Product characteristics

1
P R O D U C T
M O N O G R A P H
PR
PYLERA

Bismuth Subcitrate Potassium, Metronidazole, Tetracycline
Hydrochloride Capsules
Bismuth Subcitrate Potassium140 mg (equivalent to 40 mg Bismuth
Oxide),
Metronidazole 125 mg, Tetracycline Hydrochloride 125 mg
_Helicobacter pylori _Eradication Therapy in Conjunction with
Omeprazole
Laboratoires Juvisé Pharmaceuticals
149 boulevard Bataille de Stalingrad
Date of Preparation:
JAN 31, 2023
69100 Villeurbanne
France L6G 0B5
Distributor:
Confab Laboratories, Inc.
4355 Boul Sir-Wilfrid-Laurier
St-Hubert, Quebec
J3Y 3X3
Control # 270913
Pr
Pylera

Product Monograph
Laboratoires Juvisé Pharmaceuticals
2
NAME OF DRUG
PR
PYLERA
®
Bismuth Subcitrate Potassium, Metronidazole, Tetracycline
Hydrochloride Capsules
Bismuth Subcitrate Potassium 140 mg (equivalent to 40 mg Bismuth
Oxide),
Metronidazole 125 mg, Tetracycline Hydrochloride 125 mg
THERAPEUTIC CLASSIFICATION
_Helicobacter pylori _Eradication Therapy in Conjunction with
Omeprazole
NOTE: When used in combination with omeprazole, the product monograph
of
omeprazole must be consulted and followed.
ACTION AND CLINICAL PHARMACOLOGY
Eradication of _ H. pylori _ has been associated with decreased risk
of duodenal ulcer
recurrence. The eradication of _H. pylori _requires the concomitant
administration of various
therapeutic agents for a period of several days. Previous studies have
indicated that the
three active ingredients (bismuth subsalicylate or bismuth subcitrate,
metronidazole and
tetracycline) have been shown to be effective against _H. pylori_. All
the components were
administered separately. The mechanism of the interaction among the
three active
moieties is not known at this time.
Pr
Pylera

Product Monograph
Laboratoires Juvisé Pharmaceuticals
3
Pylera
®
(bismuth subcitrate potassium, metronidazole, and tetracycline
hydrochloride)
simplifies the administration mode of these antibacterials with the
objective of promoting
patient
compliance.
Each
component
alone
may
suppress
but
not
eradicate
the
bacterium. Coa