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ALIMENTARY TRACT AND METABOLISM › DRUGS FOR ACID RELATED DISORDERS › DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) › Combinations for eradication of Helicobacter pylori
rabeprazole, amoxicillin and metronidazole
A02BD13
Forms & Strengths
- Combination pack containing: Rabeprazole sodium enteric-coated tablet 20 mg, Amoxicillin capsule 500 mg, Metronidazole film-coated tablet 400 mg or 500 mg
Adult Dosing
- H. pylori eradication: 1 rabeprazole 20 mg tablet, 1 amoxicillin 1000 mg (two 500 mg caps), and 1 metronidazole 400 mg or 500 mg tablet taken together twice daily (morning and evening) for 7 to 14 days
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established; not recommended for use in children
Indications
- Eradication of Helicobacter pylori in patients with active peptic ulcer disease or history of duodenal ulcer
Mechanism of Action
- Rabeprazole: Proton pump inhibitor that irreversibly inhibits gastric H+/K+-ATPase pump, reducing acid secretion
- Amoxicillin: Beta-lactam antibiotic that inhibits bacterial cell wall synthesis
- Metronidazole: Synthetic nitroimidazole antimicrobial that disrupts bacterial DNA synthesis in anaerobic environments
Contraindications
- Hypersensitivity to rabeprazole, benzimidazoles, amoxicillin, penicillins, cephalosporins, metronidazole, or nitroimidazole derivatives
- Concurrent use with rilpivirine
- First trimester of pregnancy (due to metronidazole)
- History of blood dyscrasias or active central nervous system disease (due to metronidazole)
- Concurrent consumption of alcoholic beverages or propylene glycol-containing products during and for at least 3 days after metronidazole cessation
Adverse Reactions
- Diarrhea
- Nausea and vomiting
- Abdominal pain
- Headache
- Metallic taste (due to metronidazole)
- Dizziness
- Clostridioides difficile-associated diarrhea
- Hypomagnesemia and vitamin B12 deficiency (long-term rabeprazole)
- Hypersensitivity reactions including rash and urticaria
Drug Interactions
- Alcohol: Disulfiram-like reaction with metronidazole
- Warfarin/Coumarin anticoagulants: Enhanced anticoagulant effect and increased bleeding risk with metronidazole
- Lithium: Increased serum lithium levels and risk of toxicity with metronidazole
- CYP2C19 and CYP3A4 substrates: Rabeprazole may affect clearance of drugs like digoxin, methotrexate, and ketoconazole
- Gastric pH-dependent drugs (e.g., iron salts, erlotinib, dasatinib): Absorption significantly decreased by rabeprazole
- Oral contraceptives: Efficacy may be reduced by broad-spectrum antibiotics like amoxicillin
Curated Content: Needs Vetting Before Put to Clinical Use