AMOXICILLIN/ OMEPRAZOLE/ RIFABUTIN CAP,EC

Clinical Criteria Summary

Concomitant rilpivirine, voriconazole or other serious drug-drug interactions that cannot be managed (e.g. other azoles, rifampin, some HIV protease inhibitors, high-dose methotrexate)
Pregnancy
History of severe hypersensitivity to penicillins, proton pump inhibitors or rifamycins
Inability to swallow capsules whole

Documented H.pylori by laboratory test or pathology
Failure to at least one course of bismuth quadruple therapy or vonoprazan dual therapy or contraindication to BOTH

Helicobacter pylori (H. pylori) infection
Treatment-naïve patients
Treatment-experienced patients with persistent H. pylori despite treatment with optimized bismuth quadruple therapy or vonoprazan dual therapy

Suggested as a first-line alternative treatment option for treatment-naïve patients when optimized bismuth quadruple therapy cannot be used
Suggested as a salvage regimen for treatment-experienced patients with persistent H. pylori; supported by substantial data for rifabutin triple therapy given as individual components for salvage in patients with multiple treatment failures
Can be administered without the need for susceptibility testing (the only other regimen besides optimized bismuth quadruple therapy that does not require susceptibility testing)
Supported for use when optimized bismuth quadruple therapy and vonoprazan dual therapy cannot be used or have failed
Note: The co-formulated combination product has not been studied in treatment-experienced patients; however, the 2024 ACG guidelines suggest it as an alternative to individual components to potentially maximize pharmacokinetics and lower the risk of myelotoxicity

Co-formulated in a delayed release capsule containing omeprazole, rifabutin, and amoxicillin
Administer 4 capsules TID with food
Provides daily doses of 120 mg omeprazole, 150 mg rifabutin, and 2-3 g/day amoxicillin

Rifabutin is a known CYP3A4 substrate and inducer; omeprazole inhibits CYP2C19
Patients must be evaluated for drug-drug interactions prior to prescribing (e.g., azole antifungals, antiretrovirals, warfarin, methotrexate, cyclosporine, tacrolimus)