Orally for short-term treatment of erosive esophagitis in patients with GERD.
Orally to maintain healing and decrease recurrence of erosive esophagitis.
IV for up to 7–10 days in the treatment of GERD in patients with a history of erosive esophagitis. Discontinue IV therapy as soon as patient is able to initiate or resume oral therapy with the drug.
Pathologic GI Hypersecretory Conditions
Orally for long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.
IV for up to 6 days in the 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. Administer once daily for GERD. Generally given twice daily for pathologic GI hypersecretory conditions, although may be administered IV every 8 hours if necessary.
Oral Administration
Delayed-release Tablets
Administer delayed-release tablets without regard to meals.
Swallow tablets whole; do not split, crush, or chew. May administer two 20-mg tablets if unable to swallow a 40-mg tablet.
Delayed-release Oral Suspension
Administer delayed-release oral suspension 30 minutes before a meal.
Mix delayed-release granules for oral suspension with applesauce or apple juice; do not mix with any other foods or liquids (including water).
Sprinkle the contents of a single-dose packet of pantoprazole sodium delayed-release granules for oral suspension onto 1 teaspoonful of applesauce and administer within 10 minutes of preparation.
Alternatively, sprinkle the packet contents into 5 mL of apple juice, stir for 5 seconds, and swallow the resulting suspension immediately. Rinse the container once or twice with apple juice; swallow the rinsings immediately to ensure complete delivery of the dose.
Swallow granules in the oral suspension intact; do not crush or chew the granules.
NG Tube
May administer pantoprazole sodium delayed-release granules for oral suspension via a nasogastric tube (16 French or larger).
Remove the plunger from a 60-mL syringe and attach the catheter tip of the syringe to the NG tube. Empty the contents of a single-dose packet of the granules into the syringe barrel while holding the syringe as high as possible to prevent bending of the tubing. Add 10 mL of apple juice to the syringe; gently tap or shake the syringe to facilitate emptying. Rinse the syringe and tubing with 10 mL of apple juice at least 2 more times (until no granules remain). Verify patency of the tubing to ensure complete delivery of the dose.
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.)
Administer as reconstituted solution or following further dilution.
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 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce 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 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce 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
IV
40 mg once daily for 7–10 days. Discontinue IV therapy when patient is able to initiate or resume oral therapy; safety and efficacy of IV therapy for >10 days not established.
Treatment of Erosive Esophagitis
Oral
40 mg once daily for up to 8 weeks. If not healed, consider additional 8 weeks of therapy.
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
Hepatic Impairment
No dosage adjustment necessary. Dosage exceeding 40 mg daily not studied in patients with hepatic impairment.
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