Pantoprazole (Monograph)
Brand name: Protonix
Drug class: Proton-pump Inhibitors
- Antiulcer Agents
- Gastric Antisecretory Agents
- Acid-pump Inhibitors
VA class: GA900
Chemical name: 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
CAS number: 164579-32-2
Warning
A standardized concentration for this drug has been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. The drug is included in a standard concentration list which may apply to an IV or oral compounded liquid formulation. For additional information, see the ASHP website [Web].
Introduction
Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 6 7 8 10
Uses for Pantoprazole
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† [off-label].2 3 5 6 8
Gastric Ulcer
Orally for treatment of gastric ulcer† [off-label].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† [off-label], including esophageal, gastroduodenal, and jejunoileal disease.18 19 20 21 22 23 24
Related/similar drugs
amoxicillin, omeprazole, famotidine, metronidazole, Protonix, sucralfate, esomeprazole
Pantoprazole 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
OralChildren ≥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
Oral40 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
Oral40 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
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
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
Drug Interactions
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 |
||
Amoxicillin |
||
Antacids |
No clinically important effects on oral pantoprazole absorption1 |
May be used concomitantly1 |
Antipyrine |
||
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 |
||
Carbamazepine |
||
Cisapride |
||
Clarithromycin |
||
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 |
||
Diclofenac |
||
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) |
||
Glyburide |
||
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 |
||
Metronidazole |
||
Midazolam |
||
Naproxen |
||
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 |
||
Oral contraceptives (e.g., levonorgestrel/ethinyl estradiol) |
||
Phenytoin |
||
Piroxicam |
||
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 |
||
Warfarin |
Pantoprazole 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
Plasma Protein Binding
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
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
Parenteral
Solution CompatibilityHID
Compatible |
---|
Dextrose 5% in water |
Sodium chloride 0.9% |
Drug Compatibility
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
-
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
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 2024, Selected Revisions March 3, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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2. Anon. Pantoprazole (Protonix). Med Lett Drugs Ther. 2000; 42:65-6. http://www.ncbi.nlm.nih.gov/pubmed/10908422?dopt=AbstractPlus
3. Fitton A, Wiseman L. Pantoprazole: a review of its pharmacological properties and therapeutic use in acid-related disorders. Drugs. 1996; 51:460-82. http://www.ncbi.nlm.nih.gov/pubmed/8882382?dopt=AbstractPlus
4. Avner DL. Clinical experience with pantoprazole in gastroesophageal reflux disease. Clin Ther. 2000; 22:1169-85. http://www.ncbi.nlm.nih.gov/pubmed/11110229?dopt=AbstractPlus
5. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors: pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1998; 56:307-35. http://www.ncbi.nlm.nih.gov/pubmed/9777309?dopt=AbstractPlus
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. http://www.ncbi.nlm.nih.gov/pubmed/10963283?dopt=AbstractPlus
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. http://www.ncbi.nlm.nih.gov/pubmed/10364004?dopt=AbstractPlus
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. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155487.htm
16. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2003 Mar.
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