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    Supporting publications

    The following publications may provide additional data to help you learn more about ZEGERID, the Only Immediate-Release oral PPI, available in capsules and powder for oral suspension.

    Primary Manuscripts

    Castell D, Bagin R, Goldlust B, Major J, Hepburn B. Comparison of the effects of omeprazole immediate-release powder for oral suspension and pantoprazole delayed-release tablets on nocturnal acid breakthrough in patients with symptomatic gastroesophageal reflux disease. Aliment Pharmacol Ther. 2005; 21:1467-74.
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    Conrad S, Gabrielli A, Margolis B, Quartin A, Hata J, Frank W, Bagin R, Rock J, Hepburn B, Laine L. A randomized double-blind comparison of immediate-release omeprazole oral suspension vs. intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients. Crit Care Med. 2005; 33:760-765.
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    Katz PO, Koch FK, Ballard ED, Bagin RG, Gautille TC, Checani GC, Hogan DL, Pratha VSV. Comparison of the effects of immediate-release omeprazole oral suspension, delayed-release lansoprazole capsules and delayed-release esomeprazole capsules on nocturnal gastric acidity after bedtime dosing in patients with night-time GERD symptoms. Aliment Pharmacol Ther 2007; 25: 197–205.
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    Review Articles

    Castell D. Review of immediate-release omeprazole in the treatment of acid related disorders. Expert Opinion on Pharmacotherapy 2005;6(14):2501-10.
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    Fennerty MB. Immediate-release omeprazole for the treatment of nighttime GERD. Gastroenterology & Hepatology 2006; 2 (S10): 1-7.
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    Howden C. New drug review: Immediate-release omeprazole/sodium bicarbonate. Gastroenterology & Hepatology 2006; 2(5):386.
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    Katz P. Nocturnal reflux: assessing and addressing the problem. Practical Gastroenterology 2005; 29(12): 30-39. Request article from Santarus Medical Affairs
    [NOT AVAILABLE ON PUBMED]

    Small R. Advances in proton pump inhibitor therapy: an immediate-release formulation of omeprazole. Pharmacy and Therapeutics 2005; 30 (12):698-713.
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    [NOT AVAILABLE ON PUBMED]

    Vaezi MF. Bravo pH testing on and off treatment with immediate-release omeprazole. Gastroenterology & Hepatology 2007; 3(S2): 1-7.
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    APT Supplement (2005)

    Peura D. Introduction: Clinical implications of immediate-release PPI therapy in the management of GERD and upper GI bleeding. Aliment Pharmacol Ther. 2005; 22 (S3):1.
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    Kahrilas PJ, Pandolfino, JE. Review article: oesophageal pH monitoring – technologies, interpretation and correlation with clinical outcomes. Aliment Pharmacol Ther. 2005; 22 (S3): 2-9.
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    Hunt RH. Review article: the unmet needs in delayed-release proton-pump inhibitor therapy in 2005. Aliment Pharmacol Ther. 2005; 22 (S3):10-19.
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    Horn JR, Howden CW. Review article: similarities and differences among delayed-release proton-pump inhibitor formulations. Aliment Pharmacol Ther. 2005; 22 (S3):20-4.
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    Howden CW. Review article: immediate-release proton-pump inhibitor therapy–potential advantages. Aliment Pharmacol Ther. 2005; 22 (S3):25-30.
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    Katz PO. Review article: putting immediate-release proton-pump inhibitors into clinical practice – improving nocturnal acid control and avoiding the possible complications of excessive acid exposure. Aliment Pharmacol Ther. 2005; 22 (S3):31-38.
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    Fennerty MB. Review article: alternative approaches to the long-term management of GERD. Aliment Pharmacol Ther. 2005; 22 (S3):39-44.
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    Maton PN. Review article: prevention of stress-related mucosal bleeding with proton-pump inhibitors. Aliment Pharmacol Ther. 2005; 22 (S3):45-52.
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    Triadafilopoulos G. Review article: the role of antisecretory therapy in the management of non-variceal upper gastrointestinal bleeding. Aliment Pharmacol Ther. 2005; 22 (S3):53-58.
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    APT Symposium Series (2007)

    Vaezi M. Review article: oesophageal function testing- the old and the new. Aliment Pharmacol Ther 3, 1-13
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    Hunt Review article: the risks of oesophageal acid exposure-from minimal mucosal changes to malignancy. Aliment Pharmacol Ther 3, 15-22
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    Orr WC. Review article: the role of sleep in the pathogenesis of gastro-oesophageal reflux disease. Aliment Pharmacol Ther 3, 23-30
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    Shaker R. Review article: a conceptual model for the relationship of nocturnal acidity and extra-oesophageal manifestations of gastro-oesophageal reflux disease: where are we now? Aliment Pharmacol Ther 3, 31-37
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    Howden CW. Review article: pharmacological approaches to the optimal control of nocturnal intragastric acidity. Aliment Pharmacol Ther 3, 39-45
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    Other Publications with Mention of ZEGERID

    Burnett J, Balkin E. Stability and viscosity of a flavored omeprazole oral suspension for pediatric use. Am J Health-Syst Pharm 2006; 63: 2240-2247.
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    Conrad S. Comment: Proton pump inhibitor formulary considerations in the acutely ill. Part 1: Pharmacology, pharmacodynamics, and available formulations. The Annals of Pharmacotherapy 2006; 40: 997.
    Order full article from PubMed

    Devlin JW, Olsen KM. Authors' reply: Proton pump inhibitor formulary considerations in the acutely ill. Part 1: Pharmacology, pharmacodynamics, and available formulations. The Annals of Pharmacotherapy 2006; 40: 998.
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    Devlin J, Welage L, Olsen K. Proton pump inhibitor formulary considerations in the acutely ill Part 1: Pharmacology, pharmacodynamics, and available formulations. The Annals of Pharmacotherapy 2005; 39(10): 1667-1677.
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    Devlin J, Welage L, Olsen K. Proton pump inhibitor formulary considerations in the acutely ill Part 2: Clinical efficacy, safety, and economics. The Annals of Pharmacotherapy 2005; 39(11): 1844-1851.
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    Devlin J, Bakshi A, Bungay K, Olsen K. An in vitro comparison of different providers to deliver four proton pump inhibitor products through a feeding tube. The Annals of Pharmacotherapy 2006; 24:1603-1611
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    DeVault KR. Management of reflux disease in elderly patients. Gastroenterology & Hepatology 2007;3(7):527-529
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    Fock KM, Ang TL, Bee LC, Lee EJD. Proton Pump Inhibitors: Do Differences in Pharmacokinetics Translate into Differences in Clinical Outcomes? Clin Pharmacokinet 2008; 47:1-6
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    Graham D. Early heartburn relief with proton pump inhibitors and the marketing of Zegerid Clin Gastroenterol Hepatol 2005;3:1047
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    Humayun F, Hoff PT, Robinson EA. Dosing of proton pump inhibitors is suboptimal among otolaryngologists treating reflux-induced upper-respiratory disease. Otolaryngology- Head and Neck Surgery 2007;137:936-941
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    Hunt RH, Yuan Y, Yaghoobi M. GERD- New strategies and new failures. J Clin Gastroenterol 2007;41 (suppl. 2):s72-80
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    Katz P. Therapy of GERD: Nocturnal acid breakthrough in perspective. Practical Gastroenterology 2005; 12:57-62.
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    Lutsi B, Hirano I. Ambulatory pH monitoring: new advances and indications. Gastroenterology & Hepatology 2007; 2(11): 835-842
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    McQuaid KR, Laine L. Early heartburn relief with proton pump inhibitors: a systemic review and meta-analysis of clinical trials. Clin Gastroenterol Hepatol 2005;3: 553-563. Order full article from PubMed

    Metz DC, Inadomi JM, Howden CW. On-Demand Therapy for Gastroesophageal Reflux Disease. Am J Gastroenterol 2007;102:642–653
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    Katz P. Advances in GERD- The current use of proton pump inhibitor therapy in clinical GI practice. Gastroenterology & Hepatology 2006; 2(12):883-885
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    King AL, Baburajan B, Wong T. Determinants of abnormal supine reflux in 24-hr pH recordings. Digestive Diseases and Science 2007;57:2844-2849
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    Scarpignato C, Pelosini I, DiMario F. Acid suppression therapy: Where do we go from here? Digestive Diseases 2006; 24: 11-46.
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    Jain V, Mainie I, Blonski W, Sharma R, Castell DO. Immediate-release omeprazole powder: an effective alternative approach to refractory GERD. Practical Gastroenterology 2007;7:61-67
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    Johnson CE, Cober MP, Ludwig JL. Stability of partial doses of omeprazole-sodium bicarbonate oral suspension. The Annuals of Pharmacotherapy 2007;41:1954-1961
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    Abstracts

    Bakshi A, Bungay K, Olsen KM, Devlin JW. An in vitro comparison of different providers to deliver four proton pump inhibitor (PPI) products through a feeding tube. Pharmacotherapy 2005; 25(10):1456:A107.
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    Brown K, Dhat G. Effect of one dose of ZEGERID on a 4-day pH study in a trauma victim. Am J Gastroenterol 2006; 101(S2): S243.
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    Burnett J, Balkin E. Evaluation of stability and viscosity of omeprazole immediate-release oral suspension at a concentration suitable for pediatric use (2mg/mL). Gastroenterology 2005;128(2):A524.
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    Castell D, Goldlust B, Morelli G, Major J, Gautille T, Hepburn B. Omeprazole immediate-release oral suspension is more effective than pantoprazole delayed-release capsules in reducing nighttime gastric acidity in GERD patients. Am J Gastroenterol 2004;99:S39.
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    Garrean PC, Gonsalves N, Hirano I. Effect of PPI therapy on symptom association using four-day Bravo® pH recordings combining 48-hour periods off and on PPI. Am J Gastroenterol 2006; 101(S2): S71.
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    Goldlust B, Hepburn B, Hardiman Y. Nighttime dosing of omeprazole immediate-release oral suspension rapidly decreases nocturnal gastric acidity. Am J Gastroenterol 2004;99:S39.
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    Hepburn B, Goldlust B. Comparative effects of omeprazole antacid complex-immediate release (OAC-IR) and omeprazole-delayed release (OME-DR) on omeprazole pharmacokinetics (PK) and gastric pH in healthy subjects. Gastroenterology 2003;124(1):A228.
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    Hepburn B, Hardiman Y, Frank WO, Goldlust B. A loading-dose regimen (LDR) of omeprazole-immediate release oral suspension (OME-IR SUSP) increases bioavailability (healthy subjects) and achieves rapid control of gastric acidity in critically ill patients. Gastroenterology 2004;126(2):A192.
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    Hardiman Y, Frank WO, Goldlust B. Double-blind trial of omeprazole-immediate release oral suspension (OME-IR SUSP) vs. intravenous cimetidine (IV CIM) for prevention of upper gastrointestinal (UGI) bleeding in critically ill patients. Gastroenterology 2004;126(2):A77.
    Order full article from PubMed
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    Jain V, Agarwal A, Mainie I, Hila A, Blonski W, Tutuian R, Castell D. Immediate-release omeprazole powder: An effective alternative approach to refractory GERD. Am J Gastroenterol 2006; 101(S2): S42.
    Order full article from PubMed
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    Katz PO, Ballard D, Koch FK, Goldlust B, Major JM, Gautille TC, Hepburn B. Nocturnal gastric acidity after bedtime dosing of proton pump inhibitors in patients with nighttime GERD symptoms. Gastroenterology 2006;130(2):A175.
    Order full article from PubMed
    Request article from Santarus Medical Affairs

    Udeh C, Hata JS, Burrows B, Ohsfeldt R. The Institute for Healthcare Improvement (IHI) saving 100K lives campaign: Are the recommendations for stress ulcer prophylaxis (SUP) cost effective? Crit Care Med 2005; 33(12) Abstract Supplement: A5.
    Order full article from PubMed

    Poster Presentations

    Bakshi A, Bungay K, Olsen K, Devlin J. An in vitro comparison of different providers to deliver four proton pump inhibitor products through a feeding tube. Poster presentation at: American College of Clinical Pharmacy annual meeting, October 2005; San Francisco, CA.
    Order full article from PubMed

    Burnett J, Balkin E. Evaluation of stability and viscosity of omeprazole immediate-release oral suspension at concentrations suitable for pediatric use. Poster presentation at: Digestive Disease Week annual meeting, May 2005; Chicago, IL.
    Order full article from PubMed

    Castell D, Goldlust B, Morelli G, Major J, Gautille T, Hepburn B. Omeprazole immediate-release oral suspension is more effective than pantoprazole delayed-release tablets in reducing nighttime gastric acidity in GERD patients. Poster presentation at: 69th American College of Gastroenterology annual scientific meeting, October 2004; Orlando, FL.
    Order full article from PubMed
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    Goldlust B, Hepburn B, Hardiman Y. Nighttime dosing of omeprazole immediate-release oral suspension rapidly decreases nocturnal gastric acidity. Poster presentation at: 69th American College of Gastroenterology annual scientific meeting, October 2004; Orlando, FL.
    Order full article from PubMed
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    Hepburn B, Goldlust B. Comparative effects of omeprazole antacid complex-immediate release and omeprazole-delayed release on omeprazole pharmacokinetics and gastric pH in healthy subjects. Poster presentation at: Digestive Disease Week annual meeting, May 2003; Orlando, FL.
    Order full article from PubMed
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    Hepburn B, Hardiman Y, Frank W, Goldlust B. A loading-dose regimen of omeprazole immediate-release oral suspension increases bioavailability (healthy subjects) and achieves rapid control of gastric acidity in critically ill patients. Poster presentation at: Digestive Disease Week annual meeting, May 2004; New Orleans, LA.
    Order full article from PubMed
    Request article from Santarus Medical Affairs

    Katz PO, Ballard D, Koch FK, Goldlust B, Major JM, Gautille TC, Hepburn B. Nocturnal gastric acidity after bedtime dosing of proton pump inhibitors in patients with nighttime GERD symptoms. Poster Presentation at: Digestive Disease Week, May 2006; Los Angeles, CA.
    Order full article from PubMed
    Request article from Santarus Medical Affairs

    Laine L, Margolis B, Bagin R, Rock J, Hepburn B, Frank W. Double-blind trial of omeprazole immediate-release oral suspension vs. intravenous cimetidine for prevention of upper gastrointestinal bleeding in critically ill patients. Poster Presentation at: Digestive Disease Week annual meeting, May 2004; New Orleans, LA.
    Order full article from PubMed

    Udeh C, Hata JS, Burrows B, Ohsfeldt R. The Institute for Healthcare Improvement (IHI) saving 100K lives campaign: Are the recommendations for stress ulcer prophylaxis (SUP) cost effective? Poster Presentation at: Society of Critical Care Medicine 35th Critical Care Congress, January 2006; San Francisco, CA.
    Order full article from PubMed

    Next: Frequently Asked Questions

    References
    1. Data on file. Santarus, Inc.
    ZEGERID is now a preferred oral PPI on many major health plans.1
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    ZEGERID is the first and only immediate release oral PPI.

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    Please see full prescribing information.

    You can obtain additional information about ZEGERID by writing Santarus directly. To speak to a representative by phone or to report an adverse event, call Santarus' Medical Information Department at 1.888.778.0887, option 2 (M-F, 9:00 am to 7:00 pm, EST).

    Product Description
    ZEGERID contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects omeprazole from acid degradation.

    Indications and Dosing for ZEGERID
    ZEGERID is indicated for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
    (20 mg); for the short-term treatment (4-8 weeks) of erosive esophagitis diagnosed by endoscopy
    (20 mg); for maintenance of healing of erosive esophagitis (20 mg) (controlled studies do not extend beyond 12 months); for short-term treatment (4-8 weeks) of active duodenal ulcer (20 mg); for short-term treatment (4-8 weeks) of active benign gastric ulcer (40 mg); and for reduction of risk of upper gastrointestinal bleeding in critically ill patients (only powder for oral suspension 40 mg; use beyond 14 days has not been evaluated).

    Important Safety Information about ZEGERID
    The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In 178 critically ill patients treated with ZEGERID Powder for oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID Powder for oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 4 of the Full Prescribing Information. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.

    ZEGERID Capsules contain 304 mg of sodium per dose. ZEGERID Powder for oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet.

    Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.

    Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules,
    1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.

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