OMEPRAZOLE CAP,EC
Clinical Criteria Summary
Document 573: Clopidogrel and Omeprazole Drug Interaction
Criteria for Clopidogrel TAB
- Mechanism & Pharmacokinetics
- Prodrug requiring biotransformation to active metabolite via hepatic cytochrome P450 (CYP) 2C19 enzyme, which is the same metabolic pathway used by proton pump inhibitors (PPIs).
- Clinical Indications & Use Criteria
- Used as single antiplatelet therapy (SAPT) or in combination with aspirin as dual antiplatelet therapy (DAPT).
- When combined with aspirin therapy, promotes gastric ulcer bleeding and increases risk of gastrointestinal bleeding.
Criteria for Omeprazole (All Formulations)
- Clinical Indications & Use Criteria
- Indicated for patients with GERD who have LA grade C or D esophagitis or whose GERD symptoms are not adequately controlled with alternative medical therapies.
- Indicated for patients receiving any antithrombotic regimen who are at high risk of gastrointestinal bleeding.
- Management & Deprescribing Recommendations
- Recommend deprescribing according to the 2022 ACG Clinical Practice Update on De-Prescribing of Proton Pump Inhibitors as much as possible.
Criteria for Concomitant Use of Clopidogrel TAB and Omeprazole (All Formulations)
- Mechanism & Interaction Considerations
- Concurrent administration may theoretically result in competitive inhibition, potentially decreasing concentration of the active clopidogrel moiety and resulting in decreased effect on platelet aggregation factors.
- PPIs that inhibit CYP2C19, particularly omeprazole and esomeprazole, may reduce the pharmacodynamic response to clopidogrel.
- Safety & Clinical Evidence Criteria
- FDA prescribing information states to avoid concomitant use of clopidogrel with omeprazole or esomeprazole.
- Concomitant use is correlated with increased CV event risk in meta-analyses combining observational cohorts and RCTs; however, significance of this correlation is lost when evaluation is limited to RCTs and propensity score matching (PSM) of observational cohorts.
- No strong evidence that CYP2C19-inhibiting PPIs result in increased risk of ischemic events or stent thrombosis in clinical trials and propensity score-matched studies.
- Use of PPIs is associated with reduced risk of gastrointestinal bleeding in patients treated with DAPT after PCI, with no significant differences observed in incidence of MACE, MI, and all-cause death in patients with CAD on DAPT and PPIs.
- VA Practice Recommendations
- Do not limit omeprazole use in patients on clopidogrel given the lack of adverse cardiovascular effects outlined in recent guidelines.
- For patients meeting GERD or high GI bleeding risk criteria, established benefits of PPI treatment outweigh proposed but highly questionable cardiovascular risks.
- No interaction observed between concomitant use of PPIs and aspirin, prasugrel, or ticagrelor.
Document 688: H Pylori Clinical Recommendations Nov 2024
Criteria for Optimized Bismuth Quadruple Therapy
- Applies to: Bismuth subsalicylate, metronidazole, tetracycline, PPIs
- Recommended first-line treatment option for treatment-naïve patients unless contraindicated or cannot be used.
- ONLY treatment regimen that can be given to patients with documented penicillin allergy; refer to allergist if this regimen cannot be used.
- Contains: bismuth subsalicylate 2 tablets QID, metronidazole 500mg TID-QID, tetracycline (not doxycycline) 500mg QID, and PPI (at least BID or double-dose daily, 30-60 minutes before meals).
- Requires optimization of adherence; patients must be educated on completing all therapy as assigned and common side effects.
Criteria for Vonoprazan + Amoxicillin (Vonoprazan Dual Therapy)
- Applies to: Vonoprazan, amoxicillin
- Suggested as alternative first-line treatment option for treatment-naïve patients when bismuth quadruple therapy cannot be used.
- Indicated for allergies to metronidazole or tetracycline, pregnancy, or other contraindications to bismuth quadruple therapy.
- Contraindicated in patients with true penicillin allergy.
- Generally reserved for treatment-naïve patients due to reliance on a single antibiotic; no significant data exists for use in treatment-experienced patients.
Criteria for Rifabutin Triple Therapy
- Applies to: Rifabutin, amoxicillin, omeprazole/PPI (individual components or TALICIA combination product)
- Suggested as first-line alternative when optimized bismuth quadruple and vonoprazan dual therapy cannot be used or have failed.
- Recommended for treatment-experienced patients with persistent H. pylori despite treatment with optimized bismuth quadruple or vonoprazan dual therapy.
- Can be given to treatment-experienced patients without the need for susceptibility testing (only other regimen besides optimized bismuth quadruple therapy that does not require it).
- Requires evaluation for drug-drug interactions prior to prescribing due to rifabutin being a CYP3A4 substrate/inducer and omeprazole inhibiting CYP2C19.
Criteria for Vonoprazan + Clarithromycin + Amoxicillin (Vonoprazan Triple Therapy)
- Applies to: Vonoprazan, clarithromycin, amoxicillin
- Suggested as third-line treatment option if no contraindications AND the isolate has documented susceptibility to clarithromycin.
- Not suggested as first-line due to offering no benefit over vonoprazan dual therapy and adding gastrointestinal side effects, dysgeusia, QT prolongation risk, and drug-drug interaction potential.
Criteria for Levofloxacin Triple Therapy
- Applies to: Levofloxacin, PPI, amoxicillin
- Suggested as third-line treatment option if no contraindications AND the isolate has documented susceptibility to levofloxacin.
Criteria for PYLERA Combination Product
- Applies to: Bismuth subcitrate, metronidazole, tetracycline, PPI
- Suggested as an option to simplify therapy for patients with difficulty understanding and complying with traditional bismuth quadruple therapy.
- Dosing: 3 capsules QID after meals and at bedtime.
- Note: May provide lower daily doses of metronidazole (1.5g/day) and tetracycline (1.5g/day) than maximum recommended for bismuth quadruple therapy; packaged as a 10-day supply.
General H. pylori Treatment Criteria
- Applies to: All regimens/drugs discussed
- Clarithromycin triple therapy (PPI + clarithromycin + amoxicillin) is no longer recommended as an empiric treatment option in treatment-naïve patients.
- All patients found positive for H. pylori should be treated; testing to ensure eradication is required after completion of a treatment regimen.