A fixed-dose combination (FDC) of a Proton Pump Inhibitor (Pantoprazole) and a Prokinetic agent (Itopride). Pantoprazole suppresses gastric acid secretion by irreversibly inhibiting the H+/K+ ATPase enzyme system (proton pump) of the gastric parietal cell. Itopride is a dopamine D2 receptor antagonist and acetylcholinesterase inhibitor, enhancing gastrointestinal motility and accelerating gastric emptying. This combination is primarily used for the management of gastroesophageal reflux disease (GERD) and other acid-peptic disorders where impaired gastric motility is a contributing factor.
Adult: One tablet (Pantoprazole 40mg + Itopride 150mg) once daily, preferably before breakfast. In severe cases, may be increased to twice daily (morning and evening before meals) as per physician's advice. Duration: Usually 4-8 weeks for GERD.
Note: Swallow the tablet whole with a glass of water, do not crush or chew. Should be taken at least 30-60 minutes before a meal (preferably breakfast) for optimal acid suppression and prokinetic effect. Do not lie down immediately after taking the medicine.
Pantoprazole is a prodrug that accumulates in the acidic environment of the 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 acid secretion. Itopride acts as a dual-action prokinetic: 1) It antagonizes dopamine D2 receptors in the gastrointestinal tract, reducing inhibitory dopaminergic activity. 2) It inhibits acetylcholinesterase, increasing the concentration of acetylcholine at muscarinic receptors, thereby stimulating gastric motility and accelerating gastric emptying.
Pregnancy: Pregnancy Category C (US FDA). Animal studies have shown risk; adequate human studies are lacking. Use only if potential benefit justifies potential risk to the fetus. PPIs are generally considered safer than other antiulcerants. Itopride should be avoided.
Driving: Itopride may cause dizziness, drowsiness, and visual disturbances. Patients should be cautioned about driving or operating machinery until they know how the medication affects them.
| Ketoconazole, Itraconazole, Posaconazole | Pantoprazole reduces gastric acidity, leading to decreased absorption of these azole antifungals which require an acidic environment. | Major |
| Atazanavir, Rilpivirine (HIV Protease/NNRTI Inhibitors) | PPIs significantly reduce their absorption, leading to loss of virologic response. | Contraindicated/Major |
| Clopidogrel | Pantoprazole (especially via CYP2C19 inhibition) may reduce the antiplatelet activity of clopidogrel, increasing cardiovascular risk. Consider using H2 blockers or Pantoprazole at a lower dose with spacing. | 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 |
| Digoxin | Pantoprazole may increase bioavailability of digoxin, risk of toxicity. | Moderate |
| Drugs metabolized by CYP2C19 (e.g., Phenytoin, Diazepam) | Pantoprazole may inhibit their metabolism, increasing plasma levels. | Moderate |
| Other CNS depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedative effect with Itopride. | Moderate |
| Anticholinergic drugs (e.g., Dicyclomine, Atropine) | May antagonize the prokinetic effect of Itopride. | Moderate |
| Erythromycin, Levofloxacin, Amiodarone | Concomitant use with Itopride may have additive QT prolonging effects, increasing risk of Torsades de Pointes. Contraindicated. | Contraindicated/Major |
Same composition (Pantoprazole (40mg) + Itopride (150mg)), different brands: