Uses
Gastroesophageal Reflux (GERD)
Orally for short-term treatment of erosive esophagitis in patients with GERD.
Orally to maintain healing and decrease recurrence of erosive esophagitis.
IV as an alternative to oral therapy for up to 7–10 days in patients unable to continue taking tablets. Safety and efficacy of IV pantoprazole for initial treatment of erosive esophagitis not established.
Pathologic GI Hypersecretory Conditions
Orally for long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.
IV up to 6 days for treatment of pathologic hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions.
Duodenal Ulcer
Orally for treatment of duodenal ulcer†.
Gastric Ulcer
Orally for treatment of gastric ulcer†.
Crohn’s Disease-associated Ulcers
Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn’s disease†, including esophageal, gastroduodenal, and jejunoileal disease.
Dosage and Administration
Administration
Administer orally or IV.
Oral Administration
Administer orally without regard to meals.
Antacids may be used concomitantly.
Swallow tablets whole; do not split, crush, or chew. May administer two 20-mg tablets if unable to swallow a 40-mg tablet.
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer through a dedicated IV line or a Y-site.
Use of spiked IV system adapters may result in breakage of the glass vial, and currently is not recommended by the manufacturer. (See Glass Vial Breakage under Cautions.)
Reconstitution
Reconstitute vial containing 40 mg pantoprazole with 10 mL of 0.9% sodium chloride injection to provide a solution containing 4 mg/mL.
Dilution
GERD: Dilute one vial of reconstituted solution containing pantoprazole 4 mg/mL with 100 mL of compatible IV solution (see Solution Compatibility under Stability) to a concentration of about 0.4 mg/mL.
Pathologic hypersecretory conditions: Dilute 2 vials of reconstituted solution containing pantoprazole 4 mg/mL with 80 mL of compatible IV solution (see Solution Compatibility under Stability) to a concentration of 0.8 mg/mL.
Rate of Administration
GERD: Administer 40-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes or as the 0.4-mg/mL dilution over about 15 minutes (7 mL/minute).
Pathologic hypersecretory conditions: Administer 80-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes or as the 0.8-mg/mL dilution over about 15 minutes (7 mL/minute).
Dosage
Available as pantoprazole sodium; dosage expressed in terms of pantoprazole.
Adults
GERD
Treatment of Erosive Esophagitis
Oral
40 mg once daily for up to 8 weeks. If not healed, consider additional 8 weeks of therapy.
IV
40 mg once daily for 7–10 days. Discontinue IV therapy when able to resume oral; safety and efficacy of IV therapy not established for >10 days.
Maintenance of Healing of Erosive Esophagitis
Oral
40 mg once daily. Not studied for >1 year of therapy. However, chronic, lifelong therapy with proton-pump inhibitor may be appropriate.
Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
Oral
40 mg twice daily. Adjust dosage according to patient response and tolerance; continue therapy as long as necessary. May require dosages of up to 240 mg daily. Patients with Zollinger-Ellison syndrome have been treated for >2 years.
IV
80 mg every 12 hours. 80 mg every 8 hours is expected to maintain acid output <10 mEq/hour in patients requiring higher dosage. Safety and efficacy of dosages exceeding 240 mg daily or use of IV pantoprazole for >6 days not established.
Special Populations
Dosage in Hepatic Impairment
No dosage adjustment necessary. Dosage exceeding 40 mg daily not studied in patients with hepatic impairment.
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