TETRACYCLINE CAP,ORAL
Clinical Criteria Summary
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.