Q-OMEPRAZOLE CAPSULE (DELAYED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

OMEPRAZOLE

Disponibil de la:

QD PHARMACEUTICALS ULC

Codul ATC:

A02BC01

INN (nume internaţional):

OMEPRAZOLE

Dozare:

10MG

Forma farmaceutică:

CAPSULE (DELAYED RELEASE)

Compoziție:

OMEPRAZOLE 10MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PROTON-PUMP INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2015-08-21

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
PR
Q-OMEPRAZOLE
(omeprazole delayed release capsules, USP)
10 mg and 20 mg omeprazole
H
+
, K
+
-ATPase Inhibitor
QD Pharmaceuticals ULC
85 Advance Road
Toronto ON
M8Z 2S6
Date of Revision:
May 4, 2015
Submission Control Number: 183451
2
PRODUCT MONOGRAPH
PR
Q-OMEPRAZOLE
(omeprazole delayed release capsules, USP)
10 mg and 20 mg omeprazole
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
+
. 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 omeprazole 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.
There is no statistically significant change in the bioavailability
(AUC, C
max
) of amoxicillin
during concomitant treatment with omeprazole in healthy volunteers.
There is an increase in the bioavailability (AUC) and half-life of
omeprazole, and bioavailability
(AUC) and C
max
of clarithromycin, during concomitant