PYLERA Treatment Regimen for H. pylori Infection
Recommended Dosing and Administration
PYLERA (bismuth subcitrate potassium 140 mg, metronidazole 125 mg, and tetracycline 125 mg) should be administered as three capsules four times daily after meals and at bedtime for 10 days, combined with omeprazole 20 mg twice daily after morning and evening meals. 1
Specific Dosing Schedule
- Take 3 PYLERA capsules four times daily: after breakfast, after lunch, after dinner, and at bedtime 1
- Take omeprazole 20 mg twice daily with PYLERA after the morning and evening meals 1
- Swallow capsules whole with a full glass of water (8 ounces), particularly with the bedtime dose to reduce esophageal irritation risk from tetracycline 1
- Treatment duration is 10 days as per FDA labeling 1
However, current guidelines strongly recommend extending treatment to 14 days rather than the FDA-labeled 10 days, as this improves eradication success by approximately 5%. 2, 3
Expected Efficacy
- PYLERA achieves 80-90% eradication rates even in areas with high clarithromycin and metronidazole resistance 2, 3
- In clinical trials, eradication rates ranged from 93.2% to 97.6% in intent-to-treat populations 4, 5, 6
- This regimen is effective as both first-line therapy and rescue therapy after failed clarithromycin-based treatment 4, 7
- Bismuth quadruple therapy is not affected by clarithromycin resistance and overcomes metronidazole resistance through bismuth's synergistic effect 2, 3
Critical Optimization Factors
Use high-dose PPI (esomeprazole or rabeprazole 40 mg twice daily) instead of standard omeprazole 20 mg, as this increases cure rates by an additional 8-12%. 2, 3
- Take PPI 30 minutes before meals on an empty stomach without concomitant antacids 2, 3
- Extending treatment from 10 to 14 days improves eradication by approximately 5% 2, 3
- Complete adherence to the full treatment course is essential—if more than 4 doses are missed, contact the prescriber 1
Common Adverse Effects and Management
- Most frequent adverse effects (≥5%): abnormal/black stools, diarrhea, nausea, and headache 1, 6
- Adverse effects occur in 28-48% of patients but are mostly mild 5, 6
- Only 2-3.5% of patients discontinue treatment due to adverse effects 4, 6
- Diarrhea occurs in 21-41% of patients during the first week—consider adjunctive probiotics to reduce this risk and improve compliance 2
Critical Contraindications and Warnings
PYLERA is absolutely contraindicated in:
- Pregnant women—tetracycline causes permanent tooth discoloration and retardation of skeletal development 1
- Patients taking methoxyflurane (risk of fatal renal toxicity) 1
- Patients who took disulfiram within the last 2 weeks (risk of psychotic reactions) 1
- Patients with severe renal impairment 1
- Patients with Cockayne syndrome 1
Patients must avoid alcohol consumption during therapy and for at least 3 days afterward to prevent disulfiram-like reactions (abdominal cramps, nausea, vomiting, headaches, flushing). 1
Special Warnings
- Metronidazole has been shown to be carcinogenic in mice and rats—unknown if this applies to humans 1
- Risk of central and peripheral nervous system effects: encephalopathy, seizures, peripheral neuropathy, and bismuth neurotoxicity—monitor patients with CNS conditions closely 1
- Avoid sun exposure due to photosensitivity risk from tetracycline 1
- Risk of severe cutaneous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome)—discontinue at first sign of skin reaction 1
- Not recommended in patients with severe hepatic impairment 1
Confirmation of Eradication
Test for eradication success at least 4 weeks after completing therapy using urea breath test or validated monoclonal stool antigen test. 2, 3
- Discontinue PPI at least 2 weeks before testing 2, 3
- Never use serology to confirm eradication—antibodies persist long after successful treatment 8, 2
When PYLERA Fails
- After first-line PYLERA failure, use levofloxacin triple therapy (if no prior fluoroquinolone exposure): PPI twice daily + amoxicillin 1000 mg twice daily + levofloxacin 500 mg once daily for 14 days 2, 3
- After two failed eradication attempts, obtain antibiotic susceptibility testing to guide further treatment 2, 3
- Never repeat antibiotics that failed previously, especially clarithromycin and levofloxacin 2, 3