Pantoprazole is indicated in conditions where reduction of gastric acid secretion is beneficial, such as:

• Peptic ulcer disease
• Gastroesophageal reflux disease (GERD)
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (when used in combination with antibiotics)
• Zollinger-Ellison syndrome

Pantoprazole is a proton pump inhibitor (PPI) that blocks the final step of gastric acid secretion by forming a covalent bond with the H+/K+ ATPase enzyme system located on the surface of gastric parietal cells. This action inhibits both basal and stimulated gastric acid secretion, regardless of the type of stimulus, and the effect lasts for more than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40 mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

No clinically significant drug interactions have been reported in studies with Pantoprazole.

Pantoprazole is contraindicated in patients who have a known hypersensitivity or allergy to any ingredient of this formulation.

Pantoprazole is generally well tolerated during both short-term and long-term use. The most common side effects are headache and diarrhea. Less common side effects may include abdominal pain, flatulence, skin rash, insomnia, and hyperglycemia.

Pantoprazole is classified as US FDA Pregnancy Category B. However, there are no adequate and well-controlled studies in pregnant women. Since animal studies do not always predict human response, Pantoprazole should be used during pregnancy only when clearly necessary. Pantoprazole is known to be excreted in human breast milk. Therefore, a decision should be made whether to stop breastfeeding or discontinue the medicine, considering the importance of the treatment for the mother.

Patients should be advised not to split, chew, or crush Pantoprazole tablets. Long-term use of Pantoprazole may cause malabsorption of cyanocobalamin (Vitamin B12) and may increase the risk of osteoporosis-related complications.

No specific symptoms of overdose have been reported in humans. Since Pantoprazole is highly bound to plasma proteins, it is not easily removed by dialysis. Other than symptomatic and supportive treatment, no specific antidote is recommended.

Proton Pump Inhibitor

Store in a cool and dry place, protected from light and heat. Keep the medicine out of the reach of children.