A fixed-dose combination (FDC) therapy primarily indicated for the eradication of Helicobacter pylori (H. pylori) in patients with peptic ulcer disease and gastritis. This triple therapy leverages the synergistic antimicrobial effects of Tinidazole (a nitroimidazole antibiotic) and Clarithromycin (a macrolide antibiotic) against H. pylori, while Lansoprazole (a proton pump inhibitor) suppresses gastric acid, enhancing antibiotic efficacy and promoting ulcer healing.
Adult: One kit (Tinidazole 500mg + Clarithromycin 250mg + Lansoprazole 30mg) twice daily, after meals (preferably breakfast and dinner), for 7 to 14 days as prescribed.
Note: Take after food to reduce GI upset and improve Lansoprazole stability. Swallow whole with a full glass of water. Do not crush, chew, or break the Lansoprazole capsule/tablet. Maintain consistent timing of doses.
This combination acts synergistically to eradicate H. pylori. Lansoprazole potently inhibits the H+/K+ ATPase (proton pump) in gastric parietal cells, raising intragastric pH. This acid suppression: 1) Creates a hostile environment for H. pylori, 2) Increases the stability and bioavailability of acid-labile antibiotics (Clarithromycin), and 3) Promotes ulcer healing. Tinidazole enters bacterial cells and is reduced to cytotoxic intermediates that damage DNA. Clarithromycin binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis.
Pregnancy: Tinidazole: Category C (contraindicated in first trimester). Clarithromycin: Category C. Lansoprazole: Category B. Avoid use in pregnancy, especially first trimester, unless potential benefit justifies potential risk to the fetus. For H. pylori, therapy is usually deferred until after delivery.
Driving: May cause dizziness, vertigo, confusion, or visual disturbances. Patients should be cautioned about driving or operating machinery if they experience these effects.
| Warfarin/Acenoocumarol | Increased anticoagulant effect; increased risk of bleeding (CYP inhibition by Clarithromycin/Lansoprazole) | Major |
| Digoxin | Increased digoxin serum levels (P-gp inhibition by Clarithromycin); risk of toxicity | Major |
| Statins (Atorvastatin, Simvastatin, Lovastatin) | Markedly increased statin levels; high risk of myopathy/rhabdomyolysis (CYP3A4 inhibition) | Major |
| Benzodiazepines (Midazolam, Triazolam) | Increased sedation and prolonged effect (CYP3A4 inhibition) | Major |
| Antiretroviral Protease Inhibitors (Ritonavir, Saquinavir) | Mutual inhibition; increased levels of both drugs; risk of QT prolongation | Major |
| Colchicine | Increased colchicine levels; risk of severe toxicity (CYP3A4/P-gp inhibition) | Major |
| Clopidogrel | Reduced antiplatelet efficacy of Clopidogrel (CYP2C19 inhibition by Lansoprazole) | Moderate |
| Methotrexate | Increased methotrexate levels; risk of toxicity (PPI-mediated reduced renal clearance) | Moderate |
| Antacids/Sucralfate | Reduced absorption of Lansoprazole; administer at least 1 hour apart | Moderate |
| Alcohol | Disulfiram-like reaction with Tinidazole (flushing, tachycardia, nausea) | Major |
Same composition (Tinidazole (500mg) + Clarithromycin (250mg) + Lansoprazole (30mg)), different brands: