Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
OMEPRAZOLE
QD PHARMACEUTICALS ULC
A02BC01
OMEPRAZOLE
10MG
CAPSULE (DELAYED RELEASE)
OMEPRAZOLE 10MG
ORAL
30
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0121643003; AHFS:
CANCELLED PRE MARKET
2015-08-21
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 Perskaitykite visą dokumentą