OMEPRAZOLE CAPSULE (DELAYED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OMEPRAZOLE

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE

Dosage:

10MG

Pharmaceutical form:

CAPSULE (DELAYED RELEASE)

Composition:

OMEPRAZOLE 10MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2019-07-18

Summary of Product characteristics

_OMEPRAZOLE Product Monograph _
_ _
_Page 1 of 32 _
PRODUCT MONOGRAPH
PR
OMEPRAZOLE
omeprazole delayed release capsules USP
10 mg and 20 mg omeprazole
H
+
, K
+
-ATPase Inhibitor
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
Date of Revision:
October 29, 2018
www.sivem.ca CONTROL NUMBER:
221212
_OMEPRAZOLE Product Monograph _
_ _
_Page 2 of 32 _
PRODUCT MONOGRAPH
PR
OMEPRAZOLE
omeprazole delayed release capsules USP
10 mg and 20 mg omeprazole
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+. 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.
Omeprazole is absorbed rapidly. After an initial oral dose of
omeprazole, approximately 35% of
the drug is absorbed from the gastrointestinal tract. Following one
week of therapy the percentage
absorbed is 43. Neither food nor antacids have any effect on the
bioavailability. Peak plasma
levels occur within about four hours.
The terminal plasma half-life is about 40 minutes. The antisecretory
effect of omeprazole is
directly proportional to the AUC; it is not dependent on the plasma
concentration at any given
time. Omeprazole is 95% bound to plasma proteins.
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 (a