1 Dosing Considerations • No dose adjustment is required in patients with renal insufficiency, hepatic insufficiency, or in elderly patients. 3 Pharmacokinetics). 4 Drug-Drug Interactions) Product Monograph Date: September 2023 LOSEC (omeprazole delayed release capsules) Page 5 of 43 • Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
2 Recommended Dose and Dosage Adjustment Duodenal Ulcer Acute Therapy: The recommended adult oral dose is 20 mg given once daily. Healing usually occurs within two weeks. For patients not healed after this initial course of therapy, an additional two weeks of treatment is recommended.
Refractory Patients:
In patients with duodenal ulcer refractory to other treatment regimens, the recommended adult doses are 20 mg or 40 mg given once daily. Healing is usually achieved within four weeks in such patients.
Gastric Ulcer Acute Therapy:
The recommended adult dose is 20 mg given once daily. Healing usually occurs within four weeks. For patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended.
Refractory Patients:
In patients with gastric ulcer refractory to other treatment regimens, the recommended dose is 40 mg given once daily. Healing is usually achieved within eight weeks.
Maintenance Therapy for Gastric Ulcer:
About 80% of gastric ulcer patients are H. pylori-positive, and should be treated with eradication therapy, as described below. A small percentage of patients who are H. pylori-negative will experience a disease recurrence and will require maintenance treatment with an antisecretory agent.
The recommended LOSEC dose is 20 mg once daily, increased to 40 mg once daily, as necessary. NSAID-Associated Gastric or Duodenal Ulcers The issue of whether or not eradication of H. pylori in patients with NSAID-associated ulcers might have beneficial preventive effects has not yet been settled.
Acute Therapy:
In patients with NSAID-associated gastric or duodenal ulcers, the recommended adult dose is 20 mg given once daily. Symptom resolution is rapid and healing usually occurs within four weeks. For those patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended.
Maintenance Therapy:
For the prevention of relapse in patients with NSAID-associated gastric or duodenal ulcers, the recommended adult dose is 20 mg given once daily, for up to six months. Helicobacter pylori Associated Peptic Ulcer Disease Omeprazole, Amoxicillin and Clarithromycin Triple Therapy: The recommended dose for eradication of H.
pylori is LOSEC 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg, all twice daily for seven days.
Omeprazole, Metronidazole and Clarithromycin Triple Therapy:
The recommended dose for eradication of H. pylori is LOSEC 20 mg, metronidazole 500 mg and clarithromycin 250 mg, all twice daily for seven days.
Product Monograph Date:
September 2023 LOSEC (omeprazole delayed release capsules) Page 6 of 43 To ensure healing and/or symptom control, further treatment with 20 mg LOSEC once daily for up to three weeks is recommended for patients with active duodenal ulcer, and with 20-40 mg LOSEC once daily for up to 12 weeks for patients with active gastric ulcer.
Patient compliance with treatment regimens for the eradication of H. pylori has been demonstrated to have a positive effect on eradication outcome. In clinical trials, patients treated with triple-therapy regimens have shown high compliance rates.
Susceptibility testing (MIC values derived from the Agar dilution method) of H. pylori to metronidazole and clarithromycin is available for 486 primary isolates from patients with a history of duodenal ulcer in one European study. Resistance to metronidazole (MIC >8 mg/L) was detected in 131 strains (27%), while nine strains (2%) were resistant to clarithromycin (MIC >1 mg/L).
Secondary resistance to metronidazole developed in strains from four patients treated with omeprazole/metronidazole/clarithromycin. Similarly, in those patients treated with omeprazole/metronidazole/clarithromycin or omeprazole/amoxicillin/clarithromycin combinations, secondary resistance to clarithromycin developed in strains from four patients.
For amoxicillin, the MIC values at pre- or post-therapy did not indicate any primary, or the development of secondary, resistance of H. pylori.
Reflux Esophagitis Acute Therapy:
The recommended adult dose is 20 mg given once daily. In most patients, healing occurs within four weeks. For patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended.
Refractory Patients:
For patients with reflux esophagitis refractory to other treatment regimens, the recommended dose is 40 mg given once daily. Healing is usually achieved within eight weeks. , Heartburn and Regurgitation) The recommended adult dose is 20 mg given once daily.
Symptom relief should be rapid. If symptom control is not achieved after four weeks, further investigation is recommended. Zollinger-Ellison Syndrome The dose used in the treatment of Zollinger-Ellison Syndrome will vary with the individual patient.
The recommended initial dose is 60 mg, given once daily. More than 90% of the patients with the severe form of the disease and inadequate response to other therapies have been adequately controlled with doses of 20 mg to 120 mg daily.
With doses greater than 80 mg, the dose should be divided and given twice daily. Doses should be adjusted to the individual patient’s need and should continue as long as clinically indicated. d. have been administered. Special Populations Health Canada has not authorized an indication for pediatric use.
4 Administration The capsules should be swallowed […]