Pantoprazole Sodium

P

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

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .

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

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

Alternatively, sprinkle the packet contents into 5 mL of apple juice, stir for 5 seconds, 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 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 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 Verify patency of the tubing to ensure complete delivery of the dose.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

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

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

General Precautions GI Effects

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

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

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

Injection Site Reactions

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

Hepatic Effects

Mild, transient elevations of serum ALT reported with oral therapy; 0.4% incidence of serum ALT increases >3 times the upper limit of normal with pantoprazole dosage of 40 mg daily in short-term studies.1 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

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

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

Hip 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.27 300 301 302 303 304 305 309 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.27 301 303 305 307 309

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.27 303 305 307 309

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 not established in children <18 years of age.1 9 10

Geriatric Use

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

Common Adverse Effects

Oral: Short-term (up to 8 weeks): Headache,1 diarrhea,1 flatulence,1 abdominal pain,1 rash,1 eructation,1 insomnia,1 hyperglycemia.1 Long-term (up to 12 months): Headache,1 abdominal pain,1 nausea,1 vomiting,1 abnormal liver function test results.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 Metabolized by Hepatic Microsomal Enzymes

Unlikely to have clinically important interaction with drugs metabolized by CYP2C19, 3A4, 2D6, 2C9, 1A2.1 10

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 response1 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) reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel's clinical efficacy.35 224 225 228 311

Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown31 32 33 224 232

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 considered necessary, some clinicians prefer pantoprazole (which appears to be the weakest CYP2C19 inhibitor among proton-pump inhibitors)35 36 230 alternatively, consider use of a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)35 36 230 but not cimetidine (also a potent CYP2C19 inhibitor)224 232 233

Diazepam

Pharmacokinetic interaction unlikely1 10

Diclofenac

Pharmacokinetic interaction unlikely1 10

Digoxin

Pharmacokinetic interaction unlikely1 10

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

Pantoprazole may decrease drug absorption1 10

Glyburide

Pharmacokinetic interaction unlikely1 10

Metoprolol

Pharmacokinetic interaction unlikely1 10

Metronidazole

Pharmacokinetic interaction unlikely1 10

Midazolam

Pharmacokinetic interaction unlikely1 10

Naproxen

Pharmacokinetic interaction unlikely1 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

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 Delayed-release suspension is comparable to delayed-release tablets in degree of inhibition of pentagastrin-stimulated gastric acid secretion.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

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

Epinephrine HCl

Furosemide

Morphine sulfate

Nitroglycerin

Potassium chloride

Vasopressin

Incompatible

Dobutamine HCl

Esmolol HCl

Mannitol

Midazolam HCl

Multivitamins

Variable

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 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.305 309

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.

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

Wyeth

Tablets, delayed-release (enteric-coated)

20 mg (of pantoprazole)

Protonix

Wyeth

40 mg (of pantoprazole)

Protonix

Wyeth

Parenteral

For injection, for IV infusion

40 mg (of pantoprazole)

Protonix I.V.

Wyeth

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Pantoprazole Sodium 20MG Enteric-coated Tablets (WYETH): 30/$109.99 or 90/$319.95

Pantoprazole Sodium 40MG Enteric-coated Tablets (WYETH): 30/$15.99 or 90/$33.99

Protonix 20MG Enteric-coated Tablets (WYETH): 30/$186.38 or 90/$559.13

Protonix 40MG Enteric-coated Tablets (WYETH): 30/$190.00 or 90/$529.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 24, 2011. 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. Wyeth. Protonix (pantoprazole sodium) delayed-release tablets and for delayed-release oral suspension prescribing information. Philadelphia, PA; 2008 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; 2007 Dec.

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]

13. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2001 Jul 9.

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 (Nov 3, 2008). 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; 2009 Apr.

31. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 20

Pantoprazole Sodium

.