OMEPRAZOLE CAP,EC
Clinical Criteria Summary
Document 573: Clopidogrel and Omeprazole Drug Interaction
Criteria for Clopidogrel TAB and Omeprazole Formulations (CAP,EC; PWDR,RENST-ORAL; TAB,ORAL DISINTEGRATING; TAB,SA; /SODIUM BICARBONATE CAP,PWDR,SUSP)
- Clinical Indication: Gastroesophageal Reflux Disease (GERD) and Esophagitis
- For patients with GERD on clopidogrel who have LA grade C or D esophagitis or whose GERD symptoms are not adequately controlled with alternative medical therapies, the established benefits of PPI treatment outweigh proposed but highly questionable cardiovascular risks.
- Clinical Indication: Prevention of Gastrointestinal Bleeding in Dual Antiplatelet Therapy (DAPT)
- Clopidogrel is a prodrug requiring biotransformation via the hepatic cytochrome P450 (CYP) 2C19 enzyme, the same metabolic pathway used by PPIs. Concomitant use may result in competitive inhibition, potentially decreasing active clopidogrel moiety concentration and platelet aggregation effect.
- FDA prescribing information states to avoid concomitant use of clopidogrel with omeprazole or esomeprazole; a boxed warning was added to avoid use of omeprazole with clopidogrel and other potent CYP 2C19 inhibitors.
- Meta-analyses demonstrate concomitant use is correlated with an increased CV event risk, though significance is lost when evaluation is limited to RCTs and propensity score matching.
- PPI use is associated with a reduced risk of gastrointestinal bleeding in patients treated with DAPT after PCI, with no significant differences observed in MACE, MI, or all-cause death.
- PPIs reduce the risk of upper gastroduodenal bleeding in patients receiving antithrombotic regimens who are at high risk of GI bleeding.
- No interaction between concomitant use of PPIs and aspirin, prasugrel, or ticagrelor has been observed.
- VA Practice Recommendations
- Deprescribe PPIs according to the 2022 ACG Clinical Practice Update on De-Prescribing of PPIs as much as possible.
- Do not limit omeprazole use in patients on clopidogrel given the lack of adverse cardiovascular effects outlined in recent guidelines.
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.