What is the adult dosing regimen of Pylera (bismuth subcitrate potassium, metronidazole, tetracycline) for Helicobacter pylori eradication, including duration and concomitant proton‑pump inhibitor?

Pylera Dosing for H. pylori Eradication

The standard adult regimen is three Pylera capsules four times daily (after meals and at bedtime) plus omeprazole 20 mg twice daily (after morning and evening meals) for 10 days, though extending to 14 days significantly improves eradication rates by approximately 5%. 1, 2

Standard FDA-Approved Regimen

• Three Pylera capsules four times daily (after breakfast, lunch, dinner, and at bedtime) for 10 days 1
• Omeprazole 20 mg twice daily (after morning and evening meals) for 10 days 1
• Each Pylera capsule contains bismuth subcitrate potassium 140 mg, metronidazole 125 mg, and tetracycline 125 mg 1

Optimized Regimen Based on Current Guidelines

Strongly consider upgrading to a 14-day duration and using high-dose esomeprazole or rabeprazole 40 mg twice daily instead of standard-dose omeprazole, as this increases cure rates by 8–12%. 2, 3

• Pylera: three capsules four times daily for 14 days (not 10 days) 2, 3
• Esomeprazole 40 mg or rabeprazole 40 mg twice daily (30 minutes before meals) for 14 days 2, 3
• The 14-day duration achieves 93–97% eradication versus 80–82% with 7–10 days 3
• High-dose esomeprazole or rabeprazole adds an additional 8–12% improvement over standard PPIs 2, 3

Timing and Administration

• Take Pylera capsules after meals and at bedtime to minimize gastrointestinal side effects 1
• Take PPI 30 minutes before meals on an empty stomach, without concomitant antacids 2, 3
• Avoid alcohol during treatment due to disulfiram-like reactions with metronidazole 3

Efficacy Data

• Intention-to-treat eradication rates: 80–90% in treatment-naïve patients with the 10-day FDA regimen 4, 5
• Per-protocol eradication rates: 92–95% with good compliance 5, 6
• Rescue therapy (after prior failures): 86.5–88.3% eradication in intention-to-treat analysis 6, 7
• Efficacy remains high (89.6%) even after three prior treatment failures 7

Critical Optimization Factors

• Never use pantoprazole—its acid-suppression potency is markedly lower (40 mg pantoprazole ≈ 9 mg omeprazole equivalent) 2, 8
• Do not substitute doxycycline for tetracycline—multiple studies show significantly inferior results 2, 8
• Compliance is critical—the four-times-daily dosing requires clear patient education 5, 6
• Bismuth quadruple therapy is effective even against metronidazole-resistant strains due to synergistic effects 2, 8

Common Side Effects

• 46–47% of patients experience at least one side effect, most commonly nausea, diarrhea, vomiting, and black stools 5, 6
• 5.3% discontinue therapy within 5 days due to intolerance 6
• Most adverse events are mild and gastrointestinal in nature 4, 5

Confirmation of Eradication

• Test at least 4 weeks after completing therapy using urea breath test or 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 2

Special Populations

• First-choice regimen for penicillin allergy because it contains tetracycline instead of amoxicillin 2, 3
• Highly effective as rescue therapy after clarithromycin-based triple therapy failure 6, 7
• Tetracycline is not contraindicated in elderly patients—age alone does not preclude its use 2