Dosing & Uses
Dosage Forms & Strengths
oral suspension
- 40mg/packet
powder for injection
- 40mg/vial
tablet, delayed-release
- 20mg
- 40mg
Erosive Esophagitis Associated With GERD
Treatment: 40 mg PO qDay for 8-16 weeks
Maintenance of healing: 40 mg PO qDay
Alternatively, 40 mg IV qDay for 7-10 days
Short-term Treatment of GERD
Oral therapy inappropriate or not possible: 40 mg IV infusion over 15 minutes qDay for 7-10 days; switch to PO once patient able to swallow
Zollinger-Ellison Syndrome
40 mg PO qDay; up to 240 mg/day administered in some patients
80 mg IV infusion q8-12hr up to 7 days; switch to PO once patient able to swallow
Peptic Ulcer Disease (Off-label)
Duodenal ulcer: 40 mg PO qDay for 2 weeks
Gastric ulcer: 40 mg PO qDay for 4 weeks
Dosage Forms & Strengths
oral suspension
- 40mg/packet
tablet, delayed-release
- 20mg
- 40mg
Erosive Esophagitis Associated With GERD
<5 years
- Safety and efficacy not established
>5 years
- 15 kg to <40 kg: 20 mg PO qDay for up to 8 weeks
- 40 kg or greater: 40 mg PO qDay for up to 8 weeks
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
1-10%
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%)
Frequency Not Defined
Angioedema
Atrophic gastritis
Anterior ischemic optic neuropathy
Hepatocellular damage leading to hepatic failure
Interstitial nephritis
Pancreatitis
Pancytopenia
Rhabdomyolysis
Risk of anaphylaxis
Stevens-Johnson syndrome
Fatal toxic epidermal necrolysis
Erythema multiforme
Postmarketing Reports
Asthenia, fatigue, malaise
Hepatocellular damage leading to jaundice and hepatic failure
Anaphylaxis (including anaphylactic shock)
Agranulocytosis, pancytopenia
Taste disorders (ageusia, dysgeusia)
Investigations: Weight changes
Hyponatremia, hypomagnesemia
Rhabdomyolysis, bone fracture
Hallucination, confusion, insomnia, somnolence
Interstitial nephritis
Severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal), as well as angioedema (Quincke edema)
Cutaneous and systemic lupus erythematosus
Cyanocobalamin (vitamin B-12) deficiency
Clostridium difficile-associated diarrhea
Fundic gland polyps
Acute tubulointerstitial nephritis
Warnings
Contraindications
Hypersensitivity to pantoprazole or other proton pump inhibitors (PPIs)
Concomitant administration with rilpivirine containing products
Cautions
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
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
Hypomagnesemia may occur with prolonged use (>1 year); adverse effects may result, including tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels, and the PPI had to be discontinued; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically
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
Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue therapy and evaluate patients with suspected acute TIN
Pregnancy & Lactation
Pregnancy
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
Lactation
Pantoprazole and metabolites are excreted in milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium; clinical relevance of this finding not known; many drugs excreted in human milk have potential for serious adverse reactions in nursing infants; based on potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account benefit of drug to mother
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in blockage of acid secretion
Absorption
Bioavailability: 77% (PO; neither food nor antacid alters bioavailability)
Onset (PO PUD): 24 hr (initial response)
Duration (PO at steady state): 7 days (PUD)
Peak plasma time: 2.8 hr (PO); at end of infusion (IV)
Distribution
Protein bound: 98%
Vd: 11-24 L
Metabolism
Metabolized extensively by hepatic P450 enzyme CYP2C19; second pathway through CYP3A4
Slow metabolizers (3% of Caucasians and African Americans) are deficient in CPY2C19 enzyme system; plasma concentration can increase by 5-fold or more in comparison with that found in persons who have the enzyme
Metabolites: Desmethylpantoprazole sulfate conjugate (activity unknown)
Elimination
Half-life: 1 hr; increased to 3.5-10 hr with CYP2C19 deficiency
Dialyzable: No
Renal clearance: 0.1 L/hr/kg
Total body clearance: 7.6-14 L/hr
Excretion: Urine (71%); feces (18%)
Administration
Oral Administration
Switch IV patients to PO as soon as able to take tablets
Tablet should not be chewed or crushed
Administer before meals
IV Incompatibilities
Y-site: Midazolam, zinc solutions
IV Preparation
GERD with a history of erosive esophagitis
- 15-min infusion: Reconstitute with 10 mL NS, THEN further dilute with 100 mL D5W, NS, or LR to final concentration of 0.4 mg/mL
Zollinger-Ellison syndrome
- 15-min infusion: Reconstitute each vial with 10 mL NS, THEN
- Combine 2 vials and further dilute with 80 mL D5W, NS, or LR to total volume of 100 mL (concentration 0.8 mg/mL)
- 2-min injection: Reconstitute with 10 mL NS to final concentration of 4 mg/mL
IV Administration
Do not administer other IV solution simultaneously through same line
Use dedicated IV line or Y-site; stop Y-site administration if discoloration or precipitation
Infuse over 15 min no more than 3 mg/min (7 mL/min) for GERD and 6 mg/min (7 mL/min) for pathologic hypersecretory conditions
Storage
Reconstituted solution may be stored for 2 hr at room temperature before further dilution
Admixed solution may be stored for 12 hr at room temperature before administration
Store intact vials at 2-8°C (36-46°F); protect from light
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Formulary
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