Pantoprazole Dosage

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Usual Adult Dose for Erosive Esophagitis

Treatment of Erosive Esophagitis:
40 mg orally once a day for up to 8 weeks; however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Maintenance of Healing of Erosive Esophagitis:
40 mg orally once a day. Controlled studies have been limited to 12 months of pantoprazole therapy.

Usual Adult Dose for Gastroesophageal Reflux Disease

Parenteral: 40 mg once a day for 7 to 10 days, administered via intravenous infusion over a period of 15 minutes. Intravenous therapy should be discontinued as soon as the patient is able to resume oral therapy.

Oral: 40 mg orally once a day, for short-term administration (up to 8 weeks); however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Usual Adult Dose for Duodenal Ulcer

Study (n=54)
40 mg orally once a day, dose was increased every 12 weeks by 40 mg increments to a maximum of 120 mg per day, for 28 weeks. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete duodenal ulcer healing in up to 87% and 94% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Gastric Ulcer

40 mg orally once a day. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete gastric ulcer healing in up to 87% and 97% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Helicobacter pylori Infection

Study (n=242) - Triple therapy:
40 mg orally twice daily for 7 days, commonly in conjunction with clarithromycin and either amoxicillin or metronidazole to eradicate Helicobacter pylori, followed with 40 mg pantoprazole orally once daily until day 28. Triple therapy has resulted in eradication rates of greater than 95%.

The QUADRATE Study (n=405) - Quadruple therapy:
40 mg orally twice daily for 7 days, concomitantly with bismuth subcitrate and tetracycline, both four times daily, and metronidazole 200 mg three times daily and 400 mg at bedtime. Helicobacter Pylori eradication was achieved in 82% of patients.

Usual Adult Dose for Zollinger-Ellison Syndrome

Parenteral: 80 mg every 12 hours, administered by 15-minute infusion. Daily doses higher than 240 mg administered in equally divided doses by 15-minute infusion, or administered for more than 6 days have not been studied.

Oral: 40 mg twice daily, to a maximum of 240 mg per day. Some patients have received treatment with pantoprazole for more than 2 years.

Usual Adult Dose for Stress Ulcer Prophylaxis

Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting:
80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting:
80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

Usual Adult Dose for Peptic Ulcer

Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting:
80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting:
80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

Renal Dose Adjustments

No adjustments recommended

Liver Dose Adjustments

Caution should be exercised when giving pantoprazole to patients with severe hepatic impairment (Child-Pugh class C).

Dose Adjustments

For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken.

Precautions

Symptomatic response to pantoprazole therapy does not preclude the presence of gastric malignancy.

Anaphylactic shock has been reported to occur within a few minutes after intravenous pantoprazole use.

Intravenous pantoprazole has been associated with thrombophlebitis at injection site.

Rare reports of cyanocobalamin (vitamin B12) deficiency have been reported with acid-suppressing therapy. Patients receiving acid suppressing therapy over a long period of time (e.g., longer than 3 years) may be at risk of cyanocobalamin malabsorption caused by hypo- or achlorhydria.

Atrophic gastritis has been observed occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients who were Helicobacter pylori positive.

Pantoprazole intravenous contains edetate disodium (the salt form of EDTA) which is a potent chelator of metal ions including zinc. Zinc supplementation should be considered in patients treated with intravenous pantoprazole who are prone to zinc deficiency.

The safety and efficacy of pantoprazole administration for the treatment of erosive esophagitis beyond 16-weeks has not been established.

Proton pump inhibitors may interfere with the detection of Helicobacter pylori by the urea breath test. Therefore, testing for Helicobacter pylori with the urea breath test is not recommended in patients who have received proton pump inhibitors in the preceding two weeks.

Pantoprazole sodium for injection should be discontinued as soon as patient is able to resume treatment with oral pantoprazole tablets.

Proton pump inhibitors should be used with caution in patients who have hypocalcemia or hypoparathyroidism. Calcium absorption is decreased in patients with achlorhydria.

False-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors have been reported, including pantoprazole. An alternative screening method should be considered to verify positive results.

In rodents, pantoprazole was found to be carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these animal findings to humans has not been established.

The safety and efficacy in pediatric patients has not been determined.

Dialysis

No adjustments recommended in patients undergoing hemodialysis.

Other Comments

Concomitant administration of antacids or food does not significantly affect the gastrointestinal absorption of pantoprazole.

It is recommended that the tablets and suspension NOT be split, chewed or crushed.

Intravenous pantoprazole is not recommended for treatment of erosive esophagitis because of the inability of the intravenous formulation to raise gastric pH levels sufficiently to treat this condition.

Pantoprazole suspension should only be administered in apple juice or applesauce, not in water or other liquids, or foods.

Pantoprazole suspension can be administered via the nasogastric tube as follows: Separate the plunger from the barrel of a 60 mL (2 ounce) catheter tip syringe. Connect the catheter tip of the syringe to a 16 French (or larger) nasogastric tube. Hold the syringe attached to the tubing as elevated as possible during application steps to prevent any bending of the tubing in order to provide smooth flow of contents under gravity. Empty the contents of the packet into the syringe barrel. Add 10 mL of apple juice and gently tap and/or shake the barrel of the syringe to help empty the contents. Add an additional 10 mL of apple juice and gently tap and/or shake the syringe barrel to help rinse the syringe and nasogastric tube. Repeat with at least 2 additional 10 mL aliquots of apple juice. No granules should be observed in the syringe.

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