A fixed-dose combination (FDC) of a prokinetic agent (Levosulpiride) and a proton pump inhibitor (Rabeprazole) used primarily for the management of gastroesophageal reflux disease (GERD) and functional dyspepsia. Levosulpiride enhances gastric motility and has anti-emetic properties, while Rabeprazole suppresses gastric acid secretion by inhibiting the H+/K+ ATPase pump in gastric parietal cells. This combination addresses both dysmotility and hyperacidity, common in upper GI disorders prevalent in the Indian population.
Adult: One tablet (Levosulpiride 75mg + Rabeprazole 20mg) once or twice daily, 30-60 minutes before food. For GERD/Erosive Esophagitis: Usually once daily. For severe dyspepsia/motility issues: May be prescribed twice daily.
Note: Swallow the tablet whole with a glass of water. Do not crush, split, or chew. Should be taken on an empty stomach, at least 30-60 minutes before a meal (preferably breakfast and/or dinner) for optimal absorption and effect. If a dose is missed, take it as soon as remembered unless it's almost time for the next dose.
The combination works synergistically. Rabeprazole is a proton pump inhibitor that covalently binds to and irreversibly inhibits the H+/K+ ATPase enzyme system (the proton pump) on the secretory surface of gastric parietal cells, leading to profound and long-lasting inhibition of gastric acid secretion (both basal and stimulated). Levosulpiride is a selective antagonist at presynaptic dopamine D2 receptors in the gastrointestinal tract. This blockade leads to increased acetylcholine release, enhancing gastric motility (prokinetic effect), accelerating gastric emptying, and strengthening lower esophageal sphincter tone. It also has central anti-dopaminergic (anti-emetic) and mild anxiolytic effects.
Pregnancy: Category C (US FDA). Animal studies with rabeprazole show risk; no adequate human studies. Levosulpiride may affect prolactin. Use only if potential benefit justifies potential risk to the fetus. Avoid in first trimester unless absolutely necessary.
Driving: Levosulpiride may cause dizziness, drowsiness, and blurred vision, especially at the start of therapy. Patients should not drive or operate machinery until they know how the medication affects them.
| Ketoconazole, Itraconazole, Posaconazole | Rabeprazole reduces gastric acidity, decreasing absorption of these azole antifungals (which require acid for absorption). | Major |
| Digoxin | Increased gastric pH may increase bioavailability of digoxin. | Moderate |
| Warfarin | Rabeprazole may inhibit CYP2C19, potentially increasing INR. Monitor INR closely. | Moderate |
| Methotrexate | PPIs may increase methotrexate levels by reducing renal clearance, increasing toxicity risk. | Major |
| Clopidogrel | Rabeprazole (a CYP2C19 inhibitor) may reduce the antiplatelet effect of clopidogrel (a prodrug activated by CYP2C19). Consider alternative PPI like pantoprazole. | Major |
| Atazanavir, Rilpivirine (HIV drugs) | Rabeprazole reduces acidity, severely decreasing absorption of these drugs. Contraindicated. | Major |
| Other CNS depressants (Alcohol, Benzodiazepines) | Levosulpiride may potentiate sedative effects. | Moderate |
| Levodopa, Dopamine agonists | Levosulpiride (dopamine antagonist) may antagonize the effects of these Parkinson's drugs. | Major |
| Drugs prolonging QT interval (e.g., Erythromycin, Fluoroquinolones, TCAs, Antipsychotics) | Additive risk of QT prolongation and cardiac arrhythmias with levosulpiride. | Major |