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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
pantoprazole, amoxicillin, clarithromycin and metronidazole
A02BD11
Forms & Strengths
- Co-packaged combination therapy for Helicobacter pylori eradication
- Pantoprazole sodium: delayed-release tablets 40 mg
- Amoxicillin: capsules 500 mg, tablets 877 mg
- Clarithromycin: immediate-release tablets 500 mg
- Metronidazole: tablets 500 mg
Adult Dosing
- H. pylori eradication (Sequential/Concomitant regimens vary by regional guidelines)
- Standard triple therapy variant: Pantoprazole 40 mg BID plus Amoxicillin 1 g BID and Clarithromycin 500 mg BID for 7-14 days
- Quadruple therapy variant (Bismuth or Non-bismuth): Pantoprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID, and Metronidazole 500 mg TID for 10-14 days
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established for this specific multi-drug combination pack
- Use in children is generally not recommended unless directed by a pediatric gastroenterology specialist
Indications
- Eradication of Helicobacter pylori infection
- Reduction of the risk of duodenal ulcer recurrence associated with H. pylori infection
Mechanism of Action
- Pantoprazole: Proton pump inhibitor (PPI) that inhibits the H+/K+ ATPase enzyme system in gastric parietal cells, reducing acid secretion
- Amoxicillin: Bactericidal beta-lactam antibiotic that inhibits bacterial cell wall synthesis
- Clarithromycin: Macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit
- Metronidazole: Synthetic nitroimidazole antimicrobial that disrupts DNA synthesis in anaerobic bacteria and protozoa
Contraindications
- Known hypersensitivity to pantoprazole, other proton pump inhibitors, amoxicillin, other penicillins, clarithromycin, other macrolides, or metronidazole
- Concurrent use of pimozide, cisapride, terfenadine, or astemizole with clarithromycin due to risk of QT prolongation and arrhythmias
- History of clarithromycin-associated jaundice or hepatic dysfunction
- Concurrent use of rilpivirine-containing products with pantoprazole
- Cocktail contains metronidazole: contraindicates concurrent alcohol or propylene glycol ingestion during and for at least 3 days post-treatment
Adverse Reactions
- Diarrhea, loose stools, nausea, vomiting, abdominal pain, dysgeusia (altered taste)
- Headache, dizziness
- Clostridium difficile-associated diarrhea
- Hypomagnesemia, vitamin B12 deficiency (with long-term pantoprazole)
- Increased risk of bone fractures and acute interstitial nephritis
- Disulfiram-like reaction with alcohol (due to metronidazole)
- Elevated liver enzymes, rash, urticaria
Drug Interactions
- Clarithromycin is a strong CYP3A4 inhibitor and P-glycoprotein inhibitor; increases serum concentrations of CYP3A4 substrates (e.g., statins, anticoagulants, colchicine)
- Metronidazole inhibits CYP2C9 and CYP2C19; significantly increases international normalized ratio (INR) with warfarin
- Pantoprazole increases gastric pH, altering absorption of pH-dependent medications (e.g., ketoconazole, iron salts, atazanavir)
- Methotrexate: PPIs may decrease renal clearance and increase methotrexate toxicity
- Concomitant use with QT-prolonging agents increases risk of ventricular arrhythmias
Curated Content: Needs Vetting Before Put to Clinical Use