A fixed-dose combination (FDC) of a prokinetic agent (Cinitapride) and a proton pump inhibitor (Pantoprazole) used for the management of gastroesophageal reflux disease (GERD) and functional dyspepsia. Cinitapride enhances gastric motility and accelerates gastric emptying, while Pantoprazole provides potent and prolonged suppression of gastric acid secretion by irreversibly inhibiting the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. This combination addresses both the motor and acid-related components of upper GI disorders.
Adult: One tablet (Cinitapride 3mg + Pantoprazole 40mg) once daily, 30-60 minutes before breakfast. For severe GERD, the dose can be increased to twice daily (before breakfast and dinner) as per physician's advice. Duration of therapy is typically 4-8 weeks for acute treatment.
Note: Swallow the tablet whole with a glass of water. Do NOT crush, chew, or break the tablet as it is enteric-coated (Pantoprazole component). Should be taken on an empty stomach, at least 30 minutes before a meal (preferably breakfast). If a dose is missed, take it as soon as remembered unless it's almost time for the next dose. Do not double the dose.
Cinitapride is a selective serotonin 5-HT4 receptor agonist and a weak 5-HT3 receptor antagonist. This dual action enhances acetylcholine release in the myenteric plexus, stimulating gastrointestinal motility, increasing lower esophageal sphincter pressure, and accelerating gastric emptying without significant dopamine D2 receptor blockade. Pantoprazole is a substituted benzimidazole that accumulates in the acidic compartment of the parietal cell, where it is activated to a sulfenamide. This active form covalently binds to cysteine residues of the H+/K+ ATPase (proton pump), irreversibly inhibiting the final step of gastric acid secretion.
Pregnancy: Category B (US FDA) for Pantoprazole. Cinitapride: Animal studies show no risk, but human data insufficient. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid in the first trimester unless absolutely necessary.
Driving: May cause dizziness, vertigo, and visual disturbances. Patients should be cautioned about operating machinery or driving until they are sure they are not affected.
| Ketoconazole, Itraconazole, Posaconazole | Pantoprazole reduces gastric acidity, which may decrease the absorption of these azole antifungals (which require an acidic environment). | Moderate |
| Atazanavir, Rilpivirine (HIV Protease Inhibitors) | PPIs significantly reduce absorption of these drugs, leading to loss of virologic response. Concomitant use is contraindicated. | Major |
| Warfarin, Acenocoumarol | Pantoprazole may inhibit CYP2C19, potentially increasing INR and risk of bleeding. Monitor INR closely. | Moderate |
| Methotrexate (especially high-dose) | PPIs may reduce renal clearance of methotrexate, increasing toxicity. Monitor for methotrexate side effects. | Moderate |
| Clopidogrel | Pantoprazole, a moderate CYP2C19 inhibitor, may reduce the antiplatelet effect of clopidogrel (a prodrug activated by CYP2C19), potentially increasing cardiovascular risk. Consider alternative PPI (like Pantoprazole is preferred over Omeprazole) or H2 blocker. | Moderate to Major |
| Digoxin | Increased gastric pH may slightly increase bioavailability of digoxin. Monitor digoxin levels. | Minor |
| Drugs metabolized by CYP2C19 (e.g., Phenytoin, Diazepam) | Pantoprazole may competitively inhibit their metabolism, increasing plasma levels and risk of toxicity. | Moderate |
| Erythromycin, Clarithromycin, Fluconazole | These are CYP3A4 inhibitors and may increase plasma levels of Cinitapride, potentially increasing risk of QT prolongation and side effects. | Moderate |
| Levodopa | Cinitapride may accelerate gastric emptying, potentially affecting the absorption of Levodopa. | Moderate |
| Anticholinergics (e.g., Dicyclomine, Hyoscine) | May antagonize the prokinetic effect of Cinitapride. | Moderate |
Same composition (Cinitapride (3mg) + Pantoprazole (40mg)), different brands: