This is a triple-drug fixed-dose combination (FDC) therapy primarily indicated for the eradication of Helicobacter pylori (H. pylori) infection in patients with peptic ulcer disease and gastritis. The regimen combines two antibiotics (Amoxycillin and Clarithromycin) with a proton pump inhibitor (Pantoprazole) to achieve synergistic antibacterial activity in the gastric environment. This combination is a standard first-line therapy as per Indian and international guidelines for H. pylori management.
Adult: One tablet/capsule twice daily (morning and evening), typically for 7 to 14 days. Must be taken before meals.
Note: Swallow whole with a glass of water; do not crush, chew, or break the tablet/capsule (to protect the enteric coating of Pantoprazole). Take 30-60 minutes before breakfast and dinner. Complete the full prescribed course even if symptoms improve.
This combination works synergistically to eradicate H. pylori. Pantoprazole raises the gastric pH, which stabilizes acid-labile antibiotics (like clarithromycin), increases antibiotic concentration in gastric mucosa, and makes the bacterial environment less hostile. Amoxycillin inhibits bacterial cell wall synthesis. Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.
Pregnancy: Category B (Amoxycillin), Category B (Pantoprazole), Category C (Clarithromycin). Overall, this FDC is not recommended in pregnancy unless the potential benefit justifies the potential risk to the fetus. Clarithromycin has been associated with cardiovascular malformations in some studies. Use only under strict supervision of an obstetrician and gastroenterologist.
Driving: Generally safe, but patients should be cautioned about potential dizziness or vertigo associated with Clarithromycin.
| Warfarin/Acenoocumarol | Pantoprazole & Clarithromycin may increase INR; risk of bleeding. | Major |
| Digoxin | Clarithromycin increases Digoxin absorption/bioavailability; risk of toxicity. | Major |
| Statins (Atorvastatin, Simvastatin) | Clarithromycin (CYP3A4 inhibitor) increases statin levels; high risk of myopathy/rhabdomyolysis. | Major |
| Antifungals (Ketoconazole, Itraconazole) | Pantoprazole reduces absorption (requires acid); Clarithromycin increases levels. | Moderate |
| Methotrexate | PPIs may reduce renal clearance of methotrexate, increasing toxicity. | Major |
| Clopidogrel | Pantoprazole (especially via CYP2C19 inhibition) may reduce antiplatelet efficacy. Consider alternative PPI like Rabeprazole. | Moderate |
| Oral Contraceptives | Antibiotics may reduce efficacy; advise alternative non-hormonal contraception. | Moderate |
| Theophylline, Carbamazepine | Clarithromycin can increase levels; risk of toxicity. | Major |
| Rifampicin | Reduces levels of all three drugs; treatment failure. | Major |
| Antacids | May interfere with absorption of antibiotics and PPI. Administer at least 2 hours apart. | Moderate |
Same composition (Amoxycillin (750mg) + Pantoprazole (40mg) + Clarithromycin (500mg)), different brands: