A triple-drug combination therapy primarily indicated for the eradication of Helicobacter pylori (H. pylori) infection in patients with peptic ulcer disease (PUD) and gastritis. Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion, creating a favorable environment for antibiotic action and ulcer healing. Tinidazole is a nitroimidazole antibiotic effective against anaerobic bacteria and protozoa, including H. pylori. Amoxycillin is a broad-spectrum penicillin antibiotic that disrupts bacterial cell wall synthesis. This combination is a standard first-line regimen in India for H. pylori eradication, often prescribed as a 7-14 day course.
Adult: One kit/capsule/tablet twice daily (morning and evening) for 10 to 14 days. Must be taken on an empty stomach, 1 hour before meals.
Note: Swallow the tablet/capsule whole with a full glass of water. DO NOT crush, chew, or break the tablet as it is enteric-coated to protect omeprazole from stomach acid. Take at least 1 hour before food for optimal absorption and efficacy. Complete the full prescribed course even if symptoms improve.
The combination works synergistically. Omeprazole irreversibly inhibits the H+/K+ ATPase enzyme system (proton pump) at the secretory surface of gastric parietal cells, leading to profound and prolonged gastric acid suppression. This elevates gastric pH, which enhances the stability and antimicrobial efficacy of amoxycillin and tinidazole against H. pylori. Tinidazole enters bacterial cells, undergoes reduction of its nitro group, generating cytotoxic compounds that damage microbial DNA. Amoxycillin binds to penicillin-binding proteins (PBPs) on the bacterial cell wall, inhibiting the final transpeptidation step of peptidoglycan synthesis, leading to cell lysis and death.
Pregnancy: Category C (US FDA). Omeprazole: Data suggest low risk but use only if clearly needed. Tinidazole: CONTRAINDICATED in first trimester; avoid in second/third unless essential. Amoxycillin: Category A (Australian) / Category B (US FDA); generally considered safe. This FDC is best AVOIDED in pregnancy, especially first trimester.
Driving: May cause dizziness, vertigo, or visual disturbances. Patients should not drive or operate machinery if affected.
| Warfarin/Acenoocumarol | Omeprazole may inhibit CYP2C19, potentially increasing INR and risk of bleeding. Monitor INR closely. | Major |
| Clopidogrel | Omeprazole (a CYP2C19 inhibitor) may reduce the antiplatelet efficacy of clopidogrel (a prodrug), increasing cardiovascular risk. Avoid combination. | Major |
| Ketoconazole, Itraconazole, Iron salts | Reduced absorption of these drugs due to increased gastric pH from omeprazole. | Moderate |
| Methotrexate | Omeprazole may reduce renal clearance of methotrexate, increasing toxicity risk. | Major |
| Disulfiram | Concurrent use with tinidazole can increase risk of psychotic reactions. | Moderate |
| Alcohol | Disulfiram-like reaction with tinidazole (flushing, tachycardia, nausea). STRICT AVOIDANCE. | Major |
| Allopurinol | Increased risk of amoxicillin-induced skin rash. | Moderate |
| Probenecid | Decreases renal tubular secretion of amoxycillin, increasing its blood levels and risk of toxicity. | Moderate |
| Oral Contraceptives | Tinidazole may potentially reduce efficacy; use alternative non-hormonal contraception during and for 7 days after therapy. | Moderate |
Same composition (Omeprazole (20mg) + Tinidazole (500mg) + Amoxycillin (750mg)), different brands: