SANDOZ OMEPRAZOLE TABLET (DELAYED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)

Prieinama:

SANDOZ CANADA INCORPORATED

ATC kodas:

A02BC01

INN (Tarptautinis Pavadinimas):

OMEPRAZOLE

Dozė:

20MG

Vaisto forma:

TABLET (DELAYED-RELEASE)

Sudėtis:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) 20MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/500

Recepto tipas:

Prescription

Gydymo sritis:

PROTON-PUMP INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2019-08-01

Prekės savybės

Sandoz Omeprazole
Page 1 of 31
PRODUCT MONOGRAPH
PR
SANDOZ OMEPRAZOLE
Omeprazole Magnesium
10 mg and 20 mg of Omeprazole (as Omeprazole Magnesium)
Delayed-Release Tablets
H
+
, K
+
-ATPase Inhibitor
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
April 19, 2018
Boucherville, QC
J4B 7K8
Submission Control No: 214021
Sandoz Omeprazole
Page 2 of 31
PRODUCT MONOGRAPH
PR
SANDOZ OMEPRAZOLE
Omeprazole Magnesium
10 mg and 20 mg of Omeprazole
(as Omeprazole Magnesium)
Delayed-Release Tablets
THERAPEUTIC CLASSIFICATION
H
+
, K
+
-ATPase Inhibitor
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 (omeprazole
magnesium) 20 mg tablets
demonstrate the same inhibition of stimulated acid secretion and
similar effect on 24-hour
intragastric pH as omeprazole 20 mg capsules. The mean decrease in
peak acid output after
pentagastrin stimulation was approximately 70%, after 5 days of dosing
with omeprazole 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 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 one unit. Consequently, the
absorption and first pass metabolism
of the tablet take place only during a very limited period. This may
be one of the