LOSEC CAPSULES 10MG CAPSULE (DELAYED RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OMEPRAZOLE

Διαθέσιμο από:

ASTRAZENECA CANADA INC

Φαρμακολογική κατηγορία (ATC):

A02BC01

INN (Διεθνής Όνομα):

OMEPRAZOLE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

CAPSULE (DELAYED RELEASE)

Σύνθεση:

OMEPRAZOLE 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PROTON-PUMP INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0121643003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2013-12-04

Αρχείο Π.Χ.Π.

COPYRIGHT 1989, 2000, 2005 ASTRAZENECA CANADA INC.
PRODUCT MONOGRAPH
LOSEC
®
(omeprazole delayed release capsules)
10 and 20 mg omeprazole
H
+
, K
+
-ATPase Inhibitor
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
April 5, 2013
Submission Control Number: 161843
LOSEC
®
, LOSEC 1-2-3 A
®
, LOSEC 1-2-3 M
®
and the AstraZeneca logo are registered
trademarks of the AstraZeneca group of companies.
- 1 -
COPYRIGHT 1989, 2000, 2005 ASTRAZENECA CANADA INC.
PRODUCT MONOGRAPH
NAME OF DRUG
LOSEC
®
(omeprazole delayed release capsules)
10 and 20 mg omeprazole
THERAPEUTIC CLASSIFICATION
H
+
, K
+
-ATPase Inhibitor
NOTE: When used in combination with amoxicillin, clarithromycin or
metronidazole, the
Product Monographs for those agents must be consulted and followed.
ACTIONS AND CLINICAL PHARMACOLOGY
LOSEC (omeprazole) inhibits the gastric enzyme H
+
,K
+
-ATPase (the proton pump) which
catalyzes the exchange of H
+
and K
+
. It is effective in the inhibition of both basal acid
secretion and stimulated acid secretion. The inhibition is
dose-dependent. Daily oral doses of
omeprazole 20 mg and higher showed a consistent and effective acid
control. A mean
reduction of 24-hour intragastric acidity of approximately 80% was
achieved during repeated
dosing of 20 mg daily.
Treatment with LOSEC alone has been shown to suppress, but not
eradicate
_Helicobacter _
_pylori_
(
_H. pylori_
), a bacterium that is strongly associated with acid peptic disease.
Approximately 90 to 100% of patients with duodenal ulcers, and 80% of
patients with gastric
ulcers, are infected with
_H. pylori_
. Clinical evidence indicates a synergistic effect between
omeprazole and certain antibiotics in achieving eradication of
_H. pylori_
. Eradication of
_H. _
_pylori_
is associated with symptom relief, healing of mucosal lesions,
decreased rate of
duodenal ulcer recurrence and long-term remission of peptic ulcer
disease, reducing the need
for prolonged antisecretory therapy.
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