PRIVA-OMEPRAZOLE TABLET (DELAYED-RELEASE)

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)

थमां उपलब्ध:

PHARMAPAR INC

ए.टी.सी कोड:

A02BC01

INN (इंटरनेशनल नाम):

OMEPRAZOLE

डोज़:

20MG

फार्मास्यूटिकल फॉर्म:

TABLET (DELAYED-RELEASE)

रचना:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) 20MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

100

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

PROTON-PUMP INHIBITORS

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0121643001; AHFS:

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2022-07-29

उत्पाद विशेषताएं

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_Priva-OMEPRAZOLE_
PRODUCT MONOGRAPH
PR
PRIVA-
OMEPRAZOLE
(omeprazole magnesium delayed release tablets)
20 mg omeprazole as omeprazole magnesium
H
+
, K
+
-ATPASE INHIBITOR
PHARMAPAR INC.
DATE OF REVISION:
1565, Boul. Lionel-Boulet
November 18, 2019
Varennes, Quebec
J3X 1P7
CONTROL NO:
232907
Page
2
sur
42
_Priva-OMEPRAZOLE_
PRODUCT MONOGRAPH
PR
PRIVA-OMEPRAZOLE
(omeprazole magnesium delayed release tablets)
20 mg omeprazole as omeprazole magnesium
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
Omeprazole inhibits the gastric enzyme H
+
, K
+
-ATPase (the proton pump) which catalyzes the
exchange of H
+
and K
+
. Omeprazole 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.
Information from clinical
trials in patients with duodenal ulcers in remission indicate that
omeprazole magnesium 20 mg
tablets demonstrate the same inhibition of stimulated acid secretion
and similar effect on 24-
hour intragastric pH as omeprazole magnesium 20 mg capsules. The mean
decrease in peak
acid output after pentagastrin stimulation was approximately 70%,
after 5 days of dosing with
omeprazole magnesium 20 mg tablet once daily.
The 20 mg tablet and the 20 mg capsule are not bioequivalent in terms
of plasma omeprazole
AUC, C
max
and t
max
. Omeprazole magnesium 20 mg tablets demonstrate, after repeated
dosing,
increased plasma omeprazole AUC (18%) and maximum concentration (41%)
in comparison to
omeprazole 20 mg given as capsules.
The omeprazole capsule (as a multiple unit formulation) is usually
emptied gradually from the
stomach into the intestine. In contrast to the capsule, the tablet (as
a single unit formulation)
will enter the intestine and dissolve as o