A fixed-dose combination (FDC) of a prokinetic agent (Levosulpiride) and a proton pump inhibitor (Pantoprazole) used primarily for the management of gastroesophageal reflux disease (GERD) and functional dyspepsia. Levosulpiride enhances gastric motility and has antiemetic properties, while Pantoprazole provides potent and prolonged gastric acid suppression. This combination addresses both the motor and acid-related components of upper GI disorders, making it a cornerstone therapy in Indian clinical practice for conditions like non-ulcer dyspepsia and reflux esophagitis.
Adult: One tablet (Levosulpiride 75mg + Pantoprazole 40mg) twice daily, 30-60 minutes before meals. For maintenance in GERD, once daily may be sufficient.
Note: Swallow the tablet whole with a glass of water, do not crush, chew, or break. Take on an empty stomach, at least 30-60 minutes before a meal (preferably breakfast and dinner). The enteric coating ensures Pantoprazole is released in the small intestine.
The combination works synergistically. Levosulpiride acts as a selective antagonist at dopamine D2 receptors in the gastrointestinal tract and chemoreceptor trigger zone (CTZ). This blockade enhances acetylcholine release, increasing lower esophageal sphincter (LES) pressure, improving gastric emptying, and reducing nausea/vomiting. Pantoprazole is a prodrug that accumulates in the acidic parietal cell canaliculi, where it is activated to a sulfenamide. This active form covalently binds to cysteine residues on the H+/K+ ATPase (proton pump), irreversibly inhibiting the final step of gastric acid secretion.
Pregnancy: Category C (US FDA). Animal studies with Levosulpiride show adverse effects. Human data insufficient. Pantoprazole is Category B. Use only if potential benefit justifies potential risk to the fetus. Avoid in first trimester unless absolutely necessary.
Driving: May cause dizziness, drowsiness, and blurred vision, especially at start of therapy. Patients should not drive or operate heavy machinery until their response is known.
| Ketoconazole, Itraconazole, Posaconazole | Pantoprazole reduces gastric acidity, decreasing absorption of these azole antifungals (which require acid for solubility). | Major |
| Atazanavir, Rilpivirine (HIV Protease/NNRTI Inhibitors) | PPIs reduce absorption, leading to subtherapeutic levels and treatment failure. | Major |
| Clopidogrel | Pantoprazole (especially via CYP2C19 inhibition) may reduce the antiplatelet effect of Clopidogrel, increasing cardiovascular risk. Use with caution. | Major |
| Methotrexate | PPIs may decrease renal clearance of Methotrexate, increasing toxicity risk. | Major |
| Warfarin | Pantoprazole may inhibit CYP2C9, potentially increasing INR. Monitor INR closely. | Moderate |
| Diazepam, Phenytoin | Pantoprazole may inhibit their metabolism (CYP2C19), increasing plasma levels. | Moderate |
| Digoxin | Increased gastric pH may slightly increase Digoxin absorption. | Minor |
| Other CNS Depressants (Alcohol, Benzodiazepines) | Additive sedative effects with Levosulpiride. | Moderate |
| Levodopa, Dopamine Agonists | Levosulpiride antagonizes dopamine, reducing the efficacy of these Parkinson's drugs. | Major |
| Antipsychotics (Risperidone, Haloperidol) | Additive risk of extrapyramidal symptoms and hyperprolactinemia. | Major |