A fixed-dose combination (FDC) of Levosulpiride, a prokinetic and atypical antipsychotic (benzamide derivative), and Esomeprazole, a proton pump inhibitor (PPI). This combination is primarily used for the management of gastroesophageal reflux disease (GERD), non-ulcer dyspepsia, and other acid-peptic disorders where impaired gastric motility and hypersecretion of acid are concurrent issues. Levosulpiride enhances gastric emptying and motility, while Esomeprazole provides potent and prolonged suppression of gastric acid secretion.
Adult: One tablet (Levosulpiride 75mg + Esomeprazole 40mg) twice daily, 30-60 minutes before meals. For maintenance in GERD, once daily may be used.
Note: Swallow the tablet whole with a glass of water. Do not crush, chew, or break. Take on an empty stomach, at least 1 hour before a meal for optimal acid suppression by esomeprazole. Maintain a consistent timing.
The combination works synergistically. Levosulpiride acts as a selective antagonist at presynaptic dopamine D2 receptors in the chemoreceptor trigger zone (CTZ) and gastrointestinal tract, leading to antiemetic and prokinetic effects. It also has mild anxiolytic properties. Esomeprazole is the S-isomer of omeprazole and provides irreversible inhibition of the H+/K+ ATPase enzyme system (proton pump) at the secretory surface of gastric parietal cells, thus inhibiting the final step of acid production.
Pregnancy: Category not formally assigned in India. Levosulpiride: Limited data; use only if benefit justifies risk. Esomeprazole: Category B (US FDA). Use during pregnancy only if clearly needed. Avoid in first trimester unless essential.
Driving: May cause dizziness, drowsiness, and blurred vision. Patients should not drive or operate machinery until their individual response is known.
| Ketoconazole, Itraconazole, Posaconazole | Esomeprazole reduces gastric acidity, decreasing absorption of these azole antifungals. Efficacy may be reduced. | Major |
| Digoxin | Increased gastric pH may increase bioavailability of digoxin, potentially leading to toxicity. | Moderate |
| Clopidogrel | Esomeprazole (a CYP2C19 inhibitor) may reduce the antiplatelet effect of clopidogrel (a prodrug activated by CYP2C19), increasing cardiovascular risk. | Major |
| Diazepam, Phenytoin, Warfarin | Esomeprazole may inhibit CYP2C19, increasing plasma levels of these drugs. Monitor and adjust dose. | Moderate |
| Methotrexate | Concomitant PPI use may decrease renal clearance of methotrexate, increasing toxicity risk. | Major |
| Levodopa, Bromocriptine | Levosulpiride antagonizes dopamine receptors, directly opposing the effect of these anti-Parkinson drugs. | Major |
| Other CNS depressants (Alcohol, Benzodiazepines) | Additive sedative effects with levosulpiride. | Moderate |
| Drugs prolonging QT interval (e.g., Erythromycin, Fluoroquinolones, TCAs) | Additive risk of QT prolongation and torsades de pointes with levosulpiride. | Major |