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Pantoprazole Sodium

Pronunciation

Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
CAS Number: 164579-32-2
Brands: Protonix

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 6 7 8 10

Uses for Pantoprazole Sodium

Gastroesophageal Reflux (GERD)

Orally for short-term treatment of erosive esophagitis in patients with GERD.1

Orally to maintain healing and decrease recurrence of erosive esophagitis.1

IV for up to 7–10 days in the treatment of GERD in patients with a history of erosive esophagitis.10 Discontinue IV therapy as soon as patient is able to initiate or resume oral therapy with the drug.10

Pathologic GI Hypersecretory Conditions

Orally for long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.1

IV for up to 6 days in the treatment of pathologic hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions.10

Duodenal Ulcer

Orally for treatment of duodenal ulcer.2 3 5 6 8

Gastric Ulcer

Orally for treatment of gastric ulcer.2 3 5 6 8

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.18 19 20 21 22 23 24

Pantoprazole Sodium Dosage and Administration

Administration

Administer orally or IV.1 10 Administer once daily for GERD.1 10 Generally given twice daily for pathologic GI hypersecretory conditions, although may be administered IV every 8 hours if necessary.1 10

Oral Administration

Delayed-release Tablets

Administer delayed-release tablets without regard to meals.1

Antacids may be used concomitantly.1

Swallow tablets whole; do not split, crush, or chew.1 May administer two 20-mg tablets if unable to swallow a 40-mg tablet.1

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).1

Administer delayed-release oral suspension 30 minutes before a meal.1

Mix delayed-release granules for oral suspension with applesauce or apple juice; do not mix with any other foods or liquids (including water).1

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.1 Follow with sips of water, repeated as necessary, to ensure complete delivery of the dose.1

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.1 Rinse the container once or twice with apple juice; swallow the rinsings immediately to ensure complete delivery of the dose.1

Swallow granules in the oral suspension intact; do not crush or chew the granules.1

NG Tube

May administer pantoprazole sodium delayed-release granules for oral suspension via a nasogastric or gastrostomy tube (16 French or larger).1

Remove the plunger from a 60-mL syringe and attach the catheter tip of the syringe to the NG or gastrostomy tube.1 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.1 Add 10 mL of apple juice to the syringe; gently tap or shake the syringe to facilitate emptying.1 Rinse the syringe and tubing with 10 mL of apple juice at least 2 more times (until no granules remain).1

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer through a dedicated IV line or a Y-site.10

Use of spiked IV system adapters may result in breakage of the glass vial, and currently is not recommended by the manufacturer.14 15 (See Glass Vial Breakage under Cautions.)

Administer as reconstituted solution or following further dilution.10

Reconstitution

Reconstitute vial containing 40 mg pantoprazole with 10 mL of 0.9% sodium chloride injection to provide a solution containing 4 mg/mL.10

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.10

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.10

Rate of Administration

GERD: Administer 40-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.4-mg/mL dilution over about 15 minutes (7 mL/minute).10

Pathologic hypersecretory conditions: Administer 80-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.8-mg/mL dilution over about 15 minutes (7 mL/minute).10

Dosage

Available as pantoprazole sodium; dosage expressed in terms of pantoprazole.1 10

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.1 Continue for up to 8 weeks; safety beyond 8 weeks not established.1

Adults

GERD
IV

40 mg once daily for 7–10 days.10 Discontinue IV therapy when patient is able to initiate or resume oral therapy; safety and efficacy of IV therapy for >10 days not established.10

Treatment of Erosive Esophagitis
Oral

40 mg once daily for up to 8 weeks.1 2 If not healed, consider additional 8 weeks of therapy.1 2

Maintenance of Healing of Erosive Esophagitis
Oral

40 mg once daily.1 Not studied for >1 year of therapy.1 However, chronic, lifelong therapy with proton-pump inhibitor may be appropriate.12

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
Oral

40 mg twice daily.1 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 May require dosages of up to 240 mg daily.1 Patients with Zollinger-Ellison syndrome have been treated for >2 years.1

IV

80 mg every 12 hours.10 80 mg every 8 hours is expected to maintain acid output <10 mEq/hour in patients requiring higher dosage.10 Safety and efficacy of dosages exceeding 240 mg daily or use of IV pantoprazole for >6 days not established.10

Special Populations

Hepatic Impairment

No dosage adjustment necessary.1 2 3 4 10 Dosage exceeding 40 mg daily not studied in patients with hepatic impairment.1 10

Poor Metabolizers

Consider reduced dosage in pediatric patients who are poor metabolizers of CYP2C19 substrates.1

No dosage adjustment required in adults who are poor metabolizers of CYP2C19 substrates.1 10 (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).1 10 16

Warnings/Precautions

Sensitivity Reactions

Anaphylaxis

Anaphylaxis reported with IV pantoprazole.10 Immediately discontinue drug and institute appropriate medical intervention.10

Gastric Malignancy

Response to pantoprazole does not preclude presence of occult gastric neoplasm.1 10

Atrophic Gastritis

Atrophic gastritis reported occasionally with long-term pantoprazole use, especially in patients infected with Helicobacter pylori.1

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).335 336 339 340 Many patients also had other risk factors for CDAD.335 May be severe; colectomy and, rarely, death reported.335

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.335

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.335 336

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.1 27 300 301 302 303 304 305 Magnitude of risk is unclear;27 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient’s clinical condition.1 27 301 303 305 307

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.1 27 303 305 307

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.1 317 318 319 320 321 322 323 324 325 326 327 328 329 330 Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval.1 318 319 321 322 323 325 327 328 329 Paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness may occur.319 320 321 325 330 Most patients required magnesium replacement and discontinuance of the proton-pump inhibitor.1 317 319 321 322 323 324 325 326 327 330 Hypomagnesemia resolved within 1 week (median) following discontinuance and recurred within 2 weeks (median) of rechallenge.327

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.1 319 326 327 328 330

Cyanocobalamin Malabsorption

Deficiency due to malabsorption from prolonged (e.g., >3 years) gastric acid suppression reported rarely.1 Consider possibility if manifestations of cyanocobalamin deficiency occur.1

Injection Site Reactions

Injection site reactions (e.g., thrombophlebitis, abscess) associated with use of IV pantoprazole.10

Edetate Disodium Content

Pantoprazole sodium for injection contains edetate disodium (disodium EDTA), a potent metal ion (e.g., zinc) chelator.10 Consider zinc supplementation in patients prone to zinc deficiency.10 Use caution with other IV products that contain edetate disodium.10

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).25 26

Glass Vial Breakage

Breakage of pantoprazole vials reported during attempts to connect the vials to spiked IV system adapters.14 15 Potential safety issue for health-care professionals attempting to connect these system components manually or with mechanical assistance.14 15 Pantoprazole manufacturer does not recommend use of spiked IV system adapters; if such adapters are used, contact manufacturer of the adapter for assistance.14

Specific Populations

Pregnancy

Category B.1 10

Lactation

Distributed into milk.1 10 Discontinue nursing or the drug because of potential risk in nursing infants.1 10

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.1 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.1 Common adverse effects in pediatric patients include upper respiratory tract infection, headache, fever, diarrhea, vomiting, rash, and abdominal pain.1

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

Safety and efficacy of IV pantoprazole not established in pediatric patients.10

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 10

Common Adverse Effects

Oral: Headache,1 diarrhea,1 abdominal pain,1 vomiting,1 flatulence,1 dizziness,1 arthralgia.1

IV: Abdominal pain,10 headache,10 injection site reaction (e.g., thrombophlebitis, abscess),10 constipation,10 dyspepsia,10 nausea,10 diarrhea,10 insomnia,10 dizziness,10 rhinitis.10

Interactions for Pantoprazole Sodium

Extensively metabolized, principally by CYP2C19 and to a minor extent by CYP3A4, 2D6, and 2C9.1 10

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia).327 Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.1 327 (See Hypomagnesemia under Cautions.)

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Alcohol

Pharmacokinetic interaction unlikely1 10

Amoxicillin

Pharmacokinetic interaction unlikely1 10

Antacids

No clinically important effects on oral pantoprazole absorption1

May be used concomitantly1

Antipyrine

Pharmacokinetic interaction unlikely1 10

Atazanavir

Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response or development of drug resistance1 10 30

Manufacturer of pantoprazole states that concomitant administration with atazanavir is not recommended1 10

Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir29 30

For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)29 30

Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended29 30

Caffeine

Pharmacokinetic interaction unlikely1 10

Carbamazepine

Pharmacokinetic interaction unlikely1 10

Cisapride

Pharmacokinetic interaction unlikely1 10

Clarithromycin

Pharmacokinetic interaction unlikely1 10

Clopidogrel

Certain CYP2C19 inhibitors (e.g., omeprazole, esomeprazole) reduce exposure to clopidogrel’s active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel’s clinical efficacy35 224 225 228 311 350

Dexlansoprazole, lansoprazole, or pantoprazole had less effect on clopidogrel's antiplatelet activity than did omeprazole or esomeprazole224 350 351

Pantoprazole decreased exposure to the metabolite by about 14%;1 10 351 observed effects on metabolite exposure and clopidogrel-induced platelet inhibition not considered clinically important1 10 351

Manufacturer of pantoprazole states clopidogrel dosage adjustment not required if used with recommended pantoprazole dosages1 10

Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250

American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug-drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311

If concomitant therapy with a proton-pump inhibitor and clopidogrel is deemed necessary, consider using an agent with little or no CYP2C19-inhibitory activity;35 36 46 224 230 350 alternatively, consider using a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)35 36 230 but not cimetidine (also a potent CYP2C19 inhibitor)232 233

Diazepam

Pharmacokinetic interaction unlikely1 10

Diclofenac

Pharmacokinetic interaction unlikely1 10

Digoxin

Pharmacokinetic interaction unlikely1 10

Hypomagnesemia (e.g., resulting from long-term use of proton-pump inhibitors) sensitizes the myocardium to digoxin and, thus, may increase risk of digoxin-induced cardiotoxic effects327 331

Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter1 327

Diuretics (i.e., loop or thiazide diuretics)

Possible increased risk of hypomagnesemia327

Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter1 327

Fosamprenavir

Use of esomeprazole with fosamprenavir (with or without ritonavir) did not substantially affect concentrations of amprenavir (active metabolite of fosamprenavir)345

No dosage adjustment required when proton-pump inhibitors used concomitantly with fosamprenavir (with or without ritonavir)29 345

Gastric pH-dependent drugs (e.g., ampicillin esters, iron salts, ketoconazole)

Pantoprazole may alter drug absorption1 10

Glyburide

Pharmacokinetic interaction unlikely1 10

Lopinavir

Lopinavir/ritonavir: Omeprazole had no clinically important effect on plasma concentrations or AUC of lopinavir29 344

No dosage adjustment required when proton-pump inhibitors used with lopinavir/ritonavir29

Methotrexate

Possible delayed clearance and increased serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate; possible methotrexate toxicity1 10 333 334

Reported mainly with high-dose methotrexate (300 mg/m2 to 12 g/m2),1 10 333 but also reported with low dosages (e.g., 15 mg per week)333

Manufacturer of pantoprazole recommends considering temporary discontinuance of proton-pump inhibitor therapy in some patients receiving high-dose methotrexate1 10

Some clinicians recommend withholding the proton-pump inhibitor for several days before and after administration of either high-dose or low-dose methotrexate or, alternatively, substituting a histamine H2-receptor antagonist for the proton-pump inhibitor333 334

Metoprolol

Pharmacokinetic interaction unlikely1 10

Metronidazole

Pharmacokinetic interaction unlikely1 10

Midazolam

Pharmacokinetic interaction unlikely1 10

Naproxen

Pharmacokinetic interaction unlikely1 10

Nelfinavir

Omeprazole decreased peak plasma concentrations and AUCs of nelfinavir and its major active metabolite47 347

Concomitant use of nelfinavir with proton-pump inhibitors not recommended1 10

Nifedipine

Pharmacokinetic interaction unlikely1 10

Oral contraceptives (e.g., levonorgestrel/ethinyl estradiol)

Pharmacokinetic interaction unlikely1 10

Phenytoin

Pharmacokinetic interaction unlikely1 10

Piroxicam

Pharmacokinetic interaction unlikely1 10

Raltegravir

Omeprazole increased peak plasma concentration and AUC of raltegravir29 348

No dosage adjustment recommended when proton-pump inhibitors used with raltegravir29 348

Rilpivirine

Omeprazole decreased plasma concentrations and AUC of rilpivirine29 343

Concomitant use of rilpivirine and proton-pump inhibitors contraindicated29 343

Saquinavir

Ritonavir-boosted saquinavir: Omeprazole increased peak plasma concentration and AUC of saquinavir29 346

Caution advised if proton-pump inhibitor used with ritonavir-boosted saquinavir; monitor for saquinavir toxicity29 346

Sucralfate

Possible delayed proton-pump inhibitor absorption and decreased bioavailability17

Administer proton-pump inhibitor at least 30 minutes before sucralfate17

Tests for tetrahydrocannabinol (THC)

Possible false-positive results for urine screening tests for THC1 10

Use alternative confirmatory test for verification of positive results1 10

Theophylline

Pharmacokinetic interaction unlikely1 10

Warfarin

Potential increased INR and PT1 10 17

Monitor for INR and PT increases1 10 17

Pantoprazole Sodium Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract (absolute bioavailability about 77%).1 Peak plasma concentrations attained about 2.5 hours after single or multiple 40-mg oral doses (as delayed-release tablets).1 Time to peak concentration is similar (2–2.5 hours) for delayed-release suspension administered orally or via NG tube.1

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).1

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.1

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.1

15–30 minutes after single 20- to 120-mg IV infusion.10 About 96% suppression of pentagastrin-stimulated acid output within 2 hours after 80-mg IV infusion.10

Duration

Acid secretion normalized within one week after discontinuance of oral pantoprazole; no apparent rebound hypersecretion.1

24 hours after single IV infusion.10 Median percentage of time gastric pH ≥4 similar after 40 mg IV or orally daily for 5 days.10

Food

Food delays absorption of delayed-release tablets but does not affect extent or peak plasma concentrations.1

High-fat meal delays absorption of granules (sprinkled on applesauce); also decreases peak concentrations and AUC.1

Special Populations

Pharmacokinetics in patients with severe renal impairment similar to healthy individuals.1 10

Peak plasma concentrations and AUCs increased in patients with mild to severe hepatic impairment, but no more than in slow metabolizers.1 10 Minimal accumulation with once-daily dosing.1 10 (See Hepatic Impairment under Dosage and Administration.)

Distribution

Extent

Mainly extracellular.1 10 Prolonged binding to gastric parietal proton pump enzyme.1 10

Distributed into milk.1 10

Plasma Protein Binding

98%, principally albumin.1 10

Elimination

Metabolism

Metabolized in the liver, principally by CYP2C19, and to a lesser extent by CYP3A4.1 10 Metabolites appear to be inactive.1 10

Elimination Route

Excreted in urine (about 71%) and feces (18%); no unchanged drug excreted in urine.1 10

Half-life

1 hour.1 10

Special Populations

Hepatic impairment increased plasma half-life to 7–9 hours, but no more than in slow metabolizers, and minimal accumulation occurs.1 10

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.1 10

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.1 10

Not removed by hemodialysis.1 10

Stability

Storage

Oral

Delayed-release Tablets

20–25°C (may be exposed to 15–30°C).1

Granules for Delayed-release Suspension

20–25°C (may be exposed to 15–30°C).1

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).10 Protect from light.10

Store reconstituted (4 mg/mL) solution at room temperature for up to 24 hours prior to administration as 4-mg/mL solution.10 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.10 Do not freeze reconstituted solution.10 Not necessary to protect reconstituted or diluted solution from light.10

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility
Y-Site CompatibilityHID

Compatible

Ampicillin sodium

Anidulafungin

Cefazolin sodium

Ceftriaxone sodium

Dimenhydrinate

Dopamine HCl

Doripenem

Epinephrine HCl

Furosemide

Insulin, regular

Morphine sulfate

Nitroglycerin

Potassium chloride

Vasopressin

Incompatible

Dobutamine HCl

Esmolol HCl

Mannitol

Midazolam HCl

Multivitamins

Vancomycin HCl

Variable

Caspofungin acetate

Norepinephrine bitartrate

Octreotide acetate

Manufacturer states that pantoprazole sodium may be incompatible with zinc-containing preparations.10

Actions

  • Inhibits basal and stimulated gastric acid secretion.1 10

  • 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.1 2 3 4 5 6 7 8 9 10 Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.1 2 3 4 5 6 7 8 9 10

Advice to Patients

  • Importance of swallowing tablets whole, without splitting, crushing, or chewing.1

  • Delayed-release tablets may be administered without regard to meals.1

  • Importance of taking delayed-release suspension 30 minutes before a meal.1

  • Importance of instructing patients regarding proper preparation and administration of the oral suspension.1 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.1

  • 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.1 305

  • Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany).1

  • Possible increased risk of Clostridium difficile infection; importance of contacting a clinician if persistent watery stools, abdominal pain, and fever occur.335

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 10 Antacids may be used concomitantly with delayed-release tablets.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 10

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

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

Pantoprazole Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension, delayed-release (containing enteric-coated granules)

40 mg (of pantoprazole) per packet

Protonix

Pfizer

Tablets, delayed-release (enteric-coated)

20 mg (of pantoprazole)*

Pantoprazole Sodium Delayed-release Tablets

Protonix

Pfizer

40 mg (of pantoprazole)*

Pantoprazole Sodium Delayed-release Tablets

Protonix

Pfizer

Parenteral

For injection, for IV infusion

40 mg (of pantoprazole)

Protonix I.V.

Pfizer

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions February 15, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Pfizer. Protonix (pantoprazole sodium) delayed-release tablets and for delayed-release oral suspension prescribing information. Philadelphia, PA; 2012 May.

2. Anon. Pantoprazole (Protonix). Med Lett Drugs Ther. 2000; 42:65-6. [PubMed 10908422]

3. Fitton A, Wiseman L. Pantoprazole: a review of its pharmacological properties and therapeutic use in acid-related disorders. Drugs. 1996; 51:460-82. [PubMed 8882382]

4. Avner DL. Clinical experience with pantoprazole in gastroesophageal reflux disease. Clin Ther. 2000; 22:1169-85. [IDIS 455520] [PubMed 11110229]

5. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors: pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1998; 56:307-35. [PubMed 9777309]

6. Webb DD. New therapeutic options in the treatment of GERD and other acid-peptic disorders. Am J Managed Care. 2000; 6:S467-75.

7. Berardi RR. A critical evaluation of proton pump inhibitors in the treatment of gastroesophageal reflux disease. Am J Managed Care. 2000; 6:S491-505.

8. Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000; 22:266-80. [IDIS 445669] [PubMed 10963283]

9. Wyeth, St. Davids, PA: Personal communication.

10. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2012 May.

11. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2001 Feb.

12. DeVault KR, Castell DO, Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 1999; 94:1434-42. [IDIS 429620] [PubMed 10364004]

14. Kentrup WA. Dear health care professional letter regarding breakage of Protonix IV glass vials with spiked IV adaptors. Philadelphia, PA: Wyeth; 2004 Aug.

15. Food and Drug Administration. Protonix IV (pantoprazole sodium) injection [September 24, 2004: Wyeth]. MedWatch. Rockville, MD; September 2004. From FDA website.

16. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2003 Mar.

17. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.

18. Freston JW. Review article: role of proton pump inhibitors in non-H. pylori-related ulcers. Aliment Pharmacol Ther. 20001; 15(Suppl 2):2-5.

19. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s disease in adults: Practice Guidelines. Am J Gastroenterol. 2001; 96:635-43. [IDIS 461432] [PubMed 11280528]

20. Valori RM, Cockel R. Omeprazole for duodenal ulceration in Crohn’s disease. Br Med J. 1990; 300:438-9.

21. Bianchi G, Ardizzone S, Petrillo M et al. Omeprazole for peptic ulcer in Crohn’s disease. Am J Gastroenterol. 1991; 86: 245-6. [PubMed 1992643]

22. Przemioslo RT, Mee AS. Omeprazole in possible esophageal Crohn’s disease. Dig Dis Sci. 1994; 39:1594-5. [IDIS 333053] [PubMed 8026276]

23. Dickinson JB. Is omeprazole helpful in inflammatory bowel disease? J Clin Gastroenterol. 1994; 18:317-9.

24. Abrahao LJ Jr., Abrahao LJ, Vargas C et al. [Gastoduodenal Crohn’s disease—report of 4 cases and review of the literature]. (Portuguese; with English abstract.) Arq Gastroenterol. 2001; 38:57-62.

25. Laheij RJF, Sturkenboom MCJM, Hassing RJ et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004;292:1955-60.

26. Gregor JC. Acid suppression and pneumonia.; a clinical indication for rational prescribing. JAMA. 2004;292:2012-3. Editorial.

27. Yang Y-X, Lewis JD, Epstein S et al. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006; 296:2947-53. [PubMed 17190895]

28. Pratha V, Hogan DL, Lynn RB et al. Intravenous pantoprazole as initial treatment in patients with gastroesophageal reflux disease and a history of erosive esophagitis: a randomized clinical trial. Dig Dis Sci. 2006; 51:1595-601. [PubMed 16927137]

29. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (Mar 29, 2012). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

30. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2012 Mar.

31. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 2008; 51:256-60, doi:10.1016/j.jacc.2007.06.064. Accessed 2008 Dec 8. Available from website. [PubMed 18206732]

32. Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. JACC. 2008; 52:1038-9. Letter. [PubMed 18786491]

33. MEDCO. New study: A common class of GI medications reduce protection against heart attack in patients taking widely prescribed cardiovascular drug. Franklin Lakes, NJ; 2008 Nov 11. Press release from website.

34. Gilard M, Cornily JC, Boschat J. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. JACC. 2008; 52:1039. Reply.

35. . PPI interactions with clopidogrel revisited. Med Lett Drugs Ther. 2009; 51:13-4.

36. Juurlink DN, Gomes T, Ko DT et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:713-8. [PubMed 19176635]

46. Food and Drug Administration. Information on clopidogrel bisulfate (marketed as Plavix). Rockville, MD; 2010 Oct 27. From FDA website.

47. AstraZeneca. Prilosec (omeprazole) delayed-release capsules and Prilosec (omeprazole magnesium) for delayed-release oral suspension prescribing information. Wilmington, DE; 2012 Jan.

219. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 2008; 51:256-60, doi:10.1016/j.jacc.2007.06.064. Accessed 2008 Dec 8. Available from website. [PubMed 18206732]

220. Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. JACC. 2008; 52:1038-9. Letter. [PubMed 18786491]

221. MEDCO. New study: A common class of GI medications reduce protection against heart attack in patients taking widely prescribed cardiovascular drug. Franklin Lakes, NJ; 2008 Nov 11. Press release from website.

223. . PPI interactions with clopidogrel revisited. Med Lett Drugs Ther. 2009; 51:13-4.

224. Sanofi-Aventis/Bristol-Myers Squibb. Plavix, (clopidogrel bisulfate) tablets prescribing information. New York, NY; 2011 Dec.

225. Food and Drug Administration. Early communication about an ongoing safety review of clopidogrel bisulfate (marketed as Plavix). Rockville, MD; 2009 Jan 26. From FDA website.

226. Siller-Matula JM, Spiel AO, Lang IM et al. Effects of pantoprazole and esomeprazole on platelet inhibition by clopidogrel. Am Heart J. 2009; 157:148.e1-5.

227. Gilard M, Arnaud B, Le Gal G et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated to aspirin. J Thromb Haemost. 2006; 4:2508-9. [PubMed 16898956]

228. Anon. PPI interactions with clopidogrel. Med Lett Drugs Ther. 2009; 51:2-3.

229. Aubert RE, Epstein RS, Teagarden JR et al. Proton pump inhibitors effect on clopidogrel effectiveness: The clopidogrel Medco outcomes study. Circulation. 2008; 118:S_815, Abstract 3998.

230. Lau WC, Gurbel PA. The drug-drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:699-700. [PubMed 19332744]

231. Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. Plavix, (clopidogrel bisulfate) tablets prescribing information. Bridgewater, NJ; 2009 Oct.

232. Food and Drug Administration. Information for heathcare professionals: Update to the labeling of clopidogrel bisulfate (marketed as Plavix) to alert heathcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC). Rockville, MD; 2009 Nov 17. From FDA website.

233. Food and Drug Administration. Follow-up to the January 26, 2009 Early Communication about an ongoing safety review of clopidogrel bisulfate (marketed as Plavix) and omeprazole (marketed as Prilosec and Prilosec OTC). Rockville, MD; 2009 Nov 17. From FDA website.

234. Juurlink DN, Gomes T, Ko DT et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:713-8. [PubMed 19176635]

235. Ho PM, Maddox TM, Wang L et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009; 301:937-44.

236. Norgard NB, Mathews KD, Wall GC. Drug-drug interaction between clopidogrel and the proton pump inhibitors. Ann Pharmacother. 2009; 43:1266-74. [PubMed 19470853]

237. Last EJ, Sheehan AH. Review of recent evidence: potential interaction between clopidogrel and proton pump inhibitors. Am J Health Syst Pharm. 2009; 66:2117-22. [PubMed 19923312]

238. Stanek EJ, Aubert RE, Flockhart DA et al. A national study of the effect of individual proton pump inhibitors on cardiovascular outcomes in patients treated with clopidogrel following coronary stenting: the Clopidogrel Medco Outcomes Study. Available at: http://www.theheart.org/displayItem.do?primaryKey=967345&type=ppt. Accessed 2009 Dec 15.

240. Stockl KM, Le L, Zakharyan A et al. Risk of rehospitalization for patients using clopidogrel with a proton pump inhibitor. Arch Intern Med. 2010; 170:704-10. [PubMed 20421557]

243. Juurlink DN. Proton pump inhibitors and clopidogrel: putting the interaction in perspective. Circulation. 2009; 120:2310-2. [PubMed 19933929]

248. Khalique SC, Cheng-Lai A. Drug interaction between clopidogrel and proton pump inhibitors. Cardiol Rev. 2009 Jul-Aug; 17:198-200. [PubMed 19525682]

250. Rude MK, Chey WD. Proton-pump inhibitors, clopidogrel, and cardiovascular adverse events: fact, fiction, or something in between?. Gastroenterology. 2009; 137:1168-71. [PubMed 19635603]

300. Vestergaard P, Rejnmark L, Mosekilde L. Proton pump inhibitors, histamine H2 receptor antagonists, and other antacid medications and the risk of fracture. Calcif Tissue Int. 2006; 79:76-83. [PubMed 16927047]

301. Corley DA, Kubo A, Zhao W et al. Proton pump inhibitors and histamine-2 receptor antagonists are associated with hip fractures among at-risk patients. Gastroenterology. 2010; 139:93-101. [PubMed 17190895]

302. Yu EW, Blackwell T, Ensrud KE et al. Acid-suppressive medications and risk of bone loss and fracture in older adults. Calcif Tissue Int. 2008; 83:251-9. [PubMed 19931262]

303. Gray SL, LaCroix AZ, Larson J et al. Proton pump inhibitor use, hip fracture, and change in bone mineral density in postmenopausal women: results from the Women’s Health Initiative. Arch Intern Med. 2010; 170:765-71. [PubMed 20458083]

304. Targownik LE, Lix LM, Metge CJ et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ. 2008; 179:319-26. [PubMed 18695179]

305. Food and Drug Administration. Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. May 25, 2010. From FDA web site ().

307. Yang YX, Metz DC. Safety of proton pump inhibitor exposure. Gastroenterology. 2010; :. [PubMed 20727892]

308. Targownik LE, Lix LM, Leung S et al. Proton-pump inhibitor use is not associated with osteoporosis or accelerated bone mineral density loss. Gastroenterology. 2010; 138:896-904. [PubMed 19931262]

310. Kaye JA, Jick H. Proton pump inhibitor use and risk of hip fractures in patients without major risk factors. Pharmacotherapy. 2008; 28:951-9.

311. Abraham NS, Hlatky MA, Antman EM et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. A report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. JACC. 2010; 56: Published online Nov 8, 2010.

317. Furlanetto TW, Faulhaber GA. Hypomagnesemia and Proton Pump Inhibitors: Below the Tip of the Iceberg. Arch Intern Med. 2011; :. [PubMed 21555654]

318. Fernández-Fernández FJ, Sesma P, Caínzos-Romero T et al. Intermittent use of pantoprazole and famotidine in severe hypomagnesaemia due to omeprazole. Neth J Med. 2010; 68:329-30. [PubMed 21071783]

319. Mackay JD, Bladon PT. Hypomagnesaemia due to proton-pump inhibitor therapy: a clinical case series. QJM. 2010; 103:387-95. [PubMed 20378675]

320. Shabajee N, Lamb EJ, Sturgess I et al. Omeprazole and refractory hypomagnesaemia. BMJ. 2008; 337:a425. [PubMed 18617497]

321. . In brief: PPI’s and hypomagnesemia. Med Lett Drugs Ther. 2011; 53:25. [PubMed 21464802]

322. Cundy T, Dissanayake A. Severe hypomagnesaemia in long-term users of proton-pump inhibitors. Clin Endocrinol (Oxf). 2008; 69:338-41. [PubMed 18221401]

323. Broeren MA, Geerdink EA, Vader HL et al. Hypomagnesemia induced by several proton-pump inhibitors. Ann Intern Med. 2009; 151:755-6. [PubMed 19920278]

324. Metz DC, Sostek MB, Ruszniewski P et al. Effects of esomeprazole on acid output in patients with Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion. Am J Gastroenterol. 2007; 102:2648-54. [PubMed 17764495]

325. Kuipers MT, Thang HD, Arntzenius AB. Hypomagnesaemia due to use of proton pump inhibitors--a review. Neth J Med. 2009; 67:169-72. [PubMed 19581665]

326. Epstein M, McGrath S, Law F. Proton-pump inhibitors and hypomagnesemic hypoparathyroidism. N Engl J Med. 2006; 355:1834-6. [PubMed 17065651]

327. US Food and Drug Administration. FDA drug safety communication: Low magnesium levels can be associated with long-term use of proton pump inhibitor drugs (PPIs). Rockville, MD; 2011 March 2. From FDA website.

328. US Food and Drug Administration. Proton pump inhibitor drugs (PPIs): Drug safety communication- Low magnesium levels can be associated with long-term use. Rockville, MD; 2011 March 2. From FDA website.

329. Hoorn EJ, van der Hoek J, de Man RA et al. A case series of proton pump inhibitor-induced hypomagnesemia. Am J Kidney Dis. 2010; 56:112-6. [PubMed 20189276]

330. Regolisti G, Cabassi A, Parenti E et al. Severe hypomagnesemia during long-term treatment with a proton pump inhibitor. Am J Kidney Dis. 2010; 56:168-74. [PubMed 20493607]

331. GlaxoSmithKline. Lanoxin (digoxin) tablets prescribing information. Research Triangle Park, NC; 2009 Aug.

333. Bezabeh S, Mackey AC, Kluetz P et al. Accumulating evidence for a drug-drug interaction between methotrexate and proton pump inhibitors. Oncologist. 2012; 17:550-4. [PubMed 22477728]

334. Horn JR, Hansten PD. Methotrexate and proton pump inhibitors. Pharm Times. 2012; 78(4). Published online 2012 Apr 9.

335. Food and Drug Administration. Drug safety communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs). Rockville, MD; 2012 Feb 8. From FDA website. Accessed 2012 May 3l.

336. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55. [PubMed 20307191]

337. Shah S, Lewis A, Leopold D et al. Gastric acid suppression does not promote clostridial diarrhoea in the elderly. QJM. 2000; 93:175-81. [PubMed 10751237]

338. Leonard AD, Ho KM, Flexman J. Proton pump inhibitors and diarrhoea related to Clostridium difficile infection in hospitalised patients: a case-control study. Intern Med J. 2012; 42:591-4. [PubMed 22616966]

339. Kwok CS, Arthur AK, Anibueze CI et al. Risk of Clostridium difficile Infection With Acid Suppressing Drugs and Antibiotics: Meta-Analysis. Am J Gastroenterol. 2012; 107:1011-9. [PubMed 22525304]

340. Dial S, Delaney JA, Barkun AN et al. Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease. JAMA. 2005; 294:2989-95. [PubMed 16414946]

341. Nerandzic MM, Pultz MJ, Donskey CJ. Examination of potential mechanisms to explain the association between proton pump inhibitors and Clostridium difficile infection. Antimicrob Agents Chemother. 2009; 53:4133-7. [PubMed 19667292]

343. Tibotec Therapeutics. Edurant (rilpivirine) tablets prescribing information. Raritan, NJ; 2011 May.

344. Abbott Laboratories. Kaletra (lopinavir/ritonavir) oral tablets and solution prescribing information. North Chicago, IL; 2012 May.

345. ViiV Healthcare. Lexiva (fosamprenavir calcium) tablets and oral suspension prescribing information. Research Triangle Park, NC; 2012 Apr.

346. Genentech USA. Invirase (saquinavir mesylate) capsules and tablets prescribing information. South San Francisco, CA; 2012 Feb.

347. ViiV Healthcare. Viracept (nelfinavir mesylate) tablets and oral powder prescribing information. Research Triangle Park, NC; 2012 Apr.

348. Merck Sharp & Dohme. Isentress (raltegravir) film-coated tablets and chewable tablets prescribing information. Whitehouse Station, NJ; 2012 Apr.

350. Frelinger AL, Lee RD, Mulford DJ et al. A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers. J Am Coll Cardiol. 2012; 59:1304-11. [PubMed 22464259]

351. Angiolillo DJ, Gibson CM, Cheng S et al. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011; 89:65-74. [PubMed 20844485]

HID. Trissel LA. Handbook on injectable drugs. 16th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1216-21.

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