DOM-OMEPRAZOLE DR TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)

Available from:

DOMINION PHARMACAL

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE

Dosage:

10MG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2012-07-13

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
DOM-OMEPRAZOLE DR
(omeprazole magnesium delayed release tablets)
10 mg and 20 mg omeprazole
H
+
,K
+
-ATPASE INHIBITOR
Dominion Pharmacal
6111 Royalmount Avenue, Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
September 6, 2013
Submission Control No: 167050
Pr
Dom-OMEPRAZOLE DR_ Product Monograph _
_ _
_Page 2 of_
_ _
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
Dom-OMEPRAZOLE DR
(omeprazole magnesium delayed release tablets)
10 mg 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
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
a