Brand name: Protonix
Drug class: Proton-pump Inhibitors

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.

Uses for Pantoprazole Sodium

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 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^{† [off-label]}.

Gastric Ulcer

Orally for treatment of gastric ulcer^{† [off-label]}.

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^{† [off-label]}, including esophageal, gastroduodenal, and jejunoileal disease.

Pantoprazole Sodium 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.

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.

Delayed-release Oral Suspension

Do not divide the contents of a packet of delayed-release granules for oral suspension to prepare a dose that is smaller than the full labeled dose (e.g., do not use a 40-mg packet to prepare a 20-mg dose for a child who is unable to swallow the delayed-release tablets).

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. Follow with sips of water, repeated as necessary, to ensure complete delivery of the dose.

Alternatively, sprinkle the packet contents into 5 mL of apple juice, stir for 5 seconds (granules will not dissolve), 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 or gastrostomy tube (16 French or larger).

Remove the plunger from a 60-mL syringe and attach the catheter tip of the syringe to the NG or gastrostomy 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).

IV Administration

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).

Standardize 4 Safety

Standardized concentrations for pantoprazole have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label. For additional information on S4S (including updates that may be available), see [Web].

Dosage

Available as pantoprazole sodium; dosage expressed in terms of pantoprazole.

Pediatric Patients

GERD

Treatment of Erosive Esophagitis

Oral

Children ≥5 years of age: 20 mg once daily in those weighing 15 to <40 kg; 40 mg once daily in those weighing ≥40 kg. Continue for up to 8 weeks; safety beyond 8 weeks not established.

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.

Poor Metabolizers

Consider reduced dosage in pediatric patients who are poor metabolizers of CYP2C19 substrates.

No dosage adjustment required in adults who are poor metabolizers of CYP2C19 substrates. (See Elimination: Special Populations, under Pharmacokinetics.)

Cautions for Pantoprazole Sodium

Contraindications

• Known hypersensitivity to pantoprazole, any ingredient in the formulation, or to other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, omeprazole, rabeprazole).

Warnings/Precautions

Sensitivity Reactions

Anaphylaxis

Anaphylaxis reported with IV pantoprazole. Immediately discontinue drug and institute appropriate medical intervention.

Gastric Malignancy

Response to pantoprazole does not preclude presence of occult gastric neoplasm.

Atrophic Gastritis

Atrophic gastritis reported occasionally with long-term pantoprazole use, especially in patients infected with Helicobacter pylori.

Clostridium difficile Infection

Proton-pump inhibitors associated with possible increased (1.4–2.75 times) risk of Clostridium difficile infection, including C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis). Many patients also had other risk factors for CDAD. May be severe; colectomy and, rarely, death reported.

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.

Consider CDAD if persistent diarrhea develops and manage accordingly; initiate supportive therapy (e.g., fluid and electrolyte management), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Bone Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine. Magnitude of risk is unclear; causality not established. FDA is continuing to evaluate this safety concern.

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient’s clinical condition.

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients’ bone health according to current standards of care.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, reported rarely in patients receiving long-term therapy (≥3 months or, in most cases, >1 year) with proton-pump inhibitors, including pantoprazole. Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval. Paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness may occur. Most patients required magnesium replacement and discontinuance of the proton-pump inhibitor. Hypomagnesemia resolved within 1 week (median) following discontinuance and recurred within 2 weeks (median) of rechallenge.

In patients expected to receive long-term proton-pump inhibitor therapy or in patients currently receiving digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), consider measuring serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.

Cyanocobalamin Malabsorption

Deficiency due to malabsorption from prolonged (e.g., >3 years) gastric acid suppression reported rarely. Consider possibility if manifestations of cyanocobalamin deficiency occur.

Injection Site Reactions

Injection site reactions (e.g., thrombophlebitis, abscess) associated with use of IV pantoprazole.

Edetate Disodium Content

Pantoprazole sodium for injection contains edetate disodium (disodium EDTA), a potent metal ion (e.g., zinc) chelator. Consider zinc supplementation in patients prone to zinc deficiency. Use caution with other IV products that contain edetate disodium.

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).

Glass Vial Breakage

Breakage of pantoprazole vials reported during attempts to connect the vials to spiked IV system adapters. Potential safety issue for health-care professionals attempting to connect these system components manually or with mechanical assistance. Pantoprazole manufacturer does not recommend use of spiked IV system adapters; if such adapters are used, contact manufacturer of the adapter for assistance.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk. Discontinue nursing or the drug because of potential risk in nursing infants.

Pediatric Use

Safety and efficacy of oral pantoprazole for short-term treatment of erosive esophagitis associated with GERD established in pediatric patients 1–16 years of age. However, oral pantoprazole is labeled for use only in children ≥5 years of age because an appropriate dosage formulation is not available for children <5 years of age. Common adverse effects in pediatric patients include upper respiratory tract infection, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

Efficacy of oral pantoprazole not established in infants <1 year of age. Pantoprazole was not more effective than placebo in a treatment-withdrawal study in infants 1–11 months of age with symptomatic GERD.

Safety and efficacy of IV pantoprazole not established in pediatric patients.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Oral: Headache, diarrhea, abdominal pain, vomiting, flatulence, dizziness, arthralgia.

IV: Abdominal pain, headache, injection site reaction (e.g., thrombophlebitis, abscess), constipation, dyspepsia, nausea, diarrhea, insomnia, dizziness, rhinitis.

Drug Interactions

Extensively metabolized, principally by CYP2C19 and to a minor extent by CYP3A4, 2D6, and 2C9.

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia). Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter. (See Hypomagnesemia under Cautions.)

Specific Drugs and Laboratory Tests

Pantoprazole Sodium Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract (absolute bioavailability about 77%). Peak plasma concentrations attained about 2.5 hours after single or multiple 40-mg oral doses (as delayed-release tablets). Time to peak concentration is similar (2–2.5 hours) for delayed-release suspension administered orally or via NG tube.

Administration of delayed-release oral suspension (in apple juice) via NG tube is bioequivalent to oral administration of the same formulation (in applesauce or apple juice).

AUC after single oral 40-mg dose about 39% higher in children 6–11 years of age and about 10% higher in adolescents 12–16 years of age compared with adults.

Onset

51% mean inhibition of gastric acid secretion within 2.5 hours after a single 40-mg oral dose; 85% after daily administration for 7 days.

15–30 minutes after single 20- to 120-mg IV infusion. About 96% suppression of pentagastrin-stimulated acid output within 2 hours after 80-mg IV infusion.

Duration

Acid secretion normalized within one week after discontinuance of oral pantoprazole; no apparent rebound hypersecretion.

24 hours after single IV infusion. Median percentage of time gastric pH ≥4 similar after 40 mg IV or orally daily for 5 days.

Food

Food delays absorption of delayed-release tablets but does not affect extent or peak plasma concentrations.

High-fat meal delays absorption of granules (sprinkled on applesauce); also decreases peak concentrations and AUC.

Special Populations

Pharmacokinetics in patients with severe renal impairment similar to healthy individuals.

Peak plasma concentrations and AUCs increased in patients with mild to severe hepatic impairment, but no more than in slow metabolizers. Minimal accumulation with once-daily dosing. (See Hepatic Impairment under Dosage and Administration.)

Distribution

Extent

Mainly extracellular. Prolonged binding to gastric parietal proton pump enzyme.

Distributed into milk.

Plasma Protein Binding

98%, principally albumin.

Elimination

Metabolism

Metabolized in the liver, principally by CYP2C19, and to a lesser extent by CYP3A4. Metabolites appear to be inactive.

Elimination Route

Excreted in urine (about 71%) and feces (18%); no unchanged drug excreted in urine.

Half-life

1 hour.

Special Populations

Hepatic impairment increased plasma half-life to 7–9 hours, but no more than in slow metabolizers, and minimal accumulation occurs.

In adults with poor CYP2C19 metabolizer phenotype, metabolism is slower than in those with extensive (or rapid) metabolizer phenotype; elimination half-life is 3.5–10 hours, but minimal accumulation occurs with once-daily dosing.

In pediatric patients, oral clearance in poor metabolizers (CYP2C19 *2/*2 genotype) is about tenfold lower than in extensive metabolizers (CYP2C19 *1/*1) and AUC is more than sixfold higher than in extensive or intermediate (CYP2C19 *1/*x) metabolizers.

Not removed by hemodialysis.

Stability

Storage

Oral

Delayed-release Tablets

20–25°C (may be exposed to 15–30°C).

Granules for Delayed-release Suspension

20–25°C (may be exposed to 15–30°C).

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C). Protect from light.

Store reconstituted (4 mg/mL) solution at room temperature for up to 24 hours prior to administration as 4-mg/mL solution. If reconstituted solution will be further diluted, store reconstituted solution for up to 6 hours before dilution; then store diluted (0.4 or 0.8 mg/mL) solution at room temperature and use within 24 hours of initial reconstitution. Do not freeze reconstituted solution. Not necessary to protect reconstituted or diluted solution from light.

Actions

• Inhibits basal and stimulated gastric acid secretion.

• Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton- or acid pump), blocking final step in secretion of hydrochloric acid. Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.

Advice to Patients

• Importance of swallowing tablets whole, without splitting, crushing, or chewing.

• Delayed-release tablets may be administered without regard to meals.

• Importance of taking delayed-release suspension 30 minutes before a meal.

• Importance of instructing patients regarding proper preparation and administration of the oral suspension. Importance of not dividing the contents of a packet of delayed-release granules for oral suspension to prepare a dose that is smaller than the full labeled dose.

• Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.

• Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany).

• Possible increased risk of Clostridium difficile infection; importance of contacting a clinician if persistent watery stools, abdominal pain, and fever occur.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. Antacids may be used concomitantly with delayed-release tablets.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

• Pantoprazole vs. omeprazole: What's the difference between them?
• Can you take pantoprazole 40 mg twice a day?
• How long can I take pantoprazole?
• Does pantoprazole cause bloating?

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