Composition
Pantoprox tablet: Each enteric coated tablet contains Pantoprazole Sodium Sesquihydrate USP 22.56 mg equivalent to Pantoprazole 20 mg.
Pharmacology
It is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Pantoprazole blocks the final step in acid production, thus reducing gastric acidity.
Indication
• Gastro-esophageal reflux disease (in the presence of erosive reflux esophagitis)
• Symptomatic treatment of Gastro-esophageal reflux disease (in the absence of esophagitis)
• NSAID associated gastric ulcer
• Duodenal ulcer associated with Helicobacter pylori
• Zollinger-Ellison Syndrome
Dosage & administration
Pantoprazole can be taken before or after meal.
Contra-indication
Patients with known hypersensitivity to any component of the formulation.
| Indication | Dose & Frequency |
| Short term treatment of Erosive Esophagitis associated With GERD | Adult:Two Pantoprox tablets once daily for up to 8 weeks Children (5 years and older): ≥ 15 kg to < 40 kg: One Pantoprox tablet once daily for up to 8 weeks ≥ 40 kg : Two Pantoprox tablets once daily for up to 8 weeks |
| Maintenance of Healing of Erosive Esophagitis | Adults: Two Pantoprox tablets once dail |
| Pathological hypersecretory conditions including Zollinger-Ellison Syndrome | Adults: Two Pantoprox tablets twice daily |
Warning & precaution
Symptomatic response to therapy with Pantoprazole does not preclude the presence of gastric malignancy.
Side effects
Headache, flatulence, nausea, abdominal pain, diarrhea, dry mouth, dizziness/vertigo and constipation.
Use in pregnancy & lactation
Pregnancy: This drug should be used during pregnancy only if clearly needed.
Lactation: The excretion of Pantoprazole in breast milk has not been studied. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children & adolescents
Pantoprazole is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.
Drug interaction
Pantoprazole inhibits gastric acid secretion. Therefore, Pantoprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. Ketoconazole, Iron salts and Digoxin).
Overdose
Some reports of overdosage with pantoprazole have been received. No consistent symptom profile was observed after ingestion of high doses of pantoprazole.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Pantoprox Tablet: Each box contains 6x10's tablet in blister pack.
