Skip to content

Pantoprazole

    Brands

    DEA Class; Rx

    Common Brand Names; Protonix

    • Proton Pump Inhibitors

    Oral and IV gastric proton-pump inhibitor (PPI)
    Used for erosive esophagitis, GERD, Zollinger-Ellison syndrome, duodenal and gastric ulcers, H. pylori eradication with antibiotics, and stress ulcer prophylaxis
    Lowest propensity of PPIs for CYP-based drug interactions

     Indicated for the treatment of

    • Erosive Esophagitis Associated With GERD
    • Short-term Treatment of GERD
    • Zollinger-Ellison Syndrome
    • Peptic Ulcer Disease (Off-label)

    Hypersensitivity to pantoprazole or other proton pump inhibitors (PPIs)

    Concomitant administration with rilpivirine containing products

    • Headache (>4%)
    • Abdominal pain (4%)
    • Facial edema (<4%)
    • Generalized edema (<2%)
    • Chest pain (4%)
    • Diarrhea (4%)
    • Constipation (<4%)
    • Pruritus (4%)
    • Rash (4%)
    • Flatulence (<4%)
    • Hyperglycemia (1%)
    • Nausea (1%)
    • Vomiting (>4%)
    • Photosensitivity (<2%)

    PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

    Severe hepatic impairment

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4-12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

    Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported in association with use of PPIs; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation

    Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 year), high-dose therapy

    Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

    PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

    Therapy increases risk of Salmonella, Campylobacter, and other infections

    Infusion related reactions including thrombophlebitis and hypersensitivity reported

    Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin

    Acute interstitial nephritis reported in patients taking proton pump inhibitors

    Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI

    Risk of salmonella and campylobacter infections increased with use of proton pump inhibitors

    May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy with high dose methotrexate administration

    PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated

    There are no adequate and well-controlled studies in pregnant women; advise pregnant women of the potential risk of fetal harm; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus

    Adults

    80 mg/day PO/IV for most indications; up to 160 mg/day PO has been used off-label for H. pylori eradication; up to 240 mg/day PO/IV for Zollinger-Ellison syndrome.

    Geriatric

    80 mg/day PO/IV for most indications; up to 160 mg/day PO has been used off-label for H. pylori eradication; up to 240 mg/day PO/IV for Zollinger-Ellison syndrome.

    Adolescents

    weight 40 kg or more: 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day PO has been used off-label for H. pylori eradication; limited data available for off-label IV use.
    weight less than 40 kg: 20 mg/day PO is FDA-approved maximum; however, up to 2.5 mg/kg/day (Max: 80 mg/day) PO has been used off-label for H. pylori eradication; limited data available for off-label IV use.

    Children

    5 to 12 years and weight 40 kg or more: 40 mg/day PO is FDA-approved maximum; however, up to 80 mg/day PO has been used off-label for H. pylori eradication; limited data available for off-label IV use.
    5 to 12 years and weight 15 to 39 kg: 20 mg/day PO is FDA-approved maximum; however, up to 2.5 mg/kg/day (Max: 80 mg/day) PO has been used off-label for H. pylori eradication; limited data available for off-label IV use.
    1 to 4 years or weight less than 15 kg: up to 2.5 mg/kg/day PO has been used off-label; limited data available for off-label IV use.

    Infants

    1.2 mg/kg/day PO off-label; limited data available for off-label IV use.

    Neonates

    1.2 mg/kg/day PO suggested by limited off-label data; very limited data available for off-label IV use.

    Pantoprazole sodium

    oral suspension

    • 40mg/packet

    powder for injection

    • 40mg/vial

    tablet, delayed-release

    • 20mg
    • 40mg