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Supporting Publications


The following publications may provide additional data to help you learn more about ZEGERID, the First and 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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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.

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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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APT Supplement

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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Other Publications with Mention of Zegerid

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.

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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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Graham D. Early heartburn relief with proton pump inhibitors and the marketing of Zegerid. Clin Gastroenterol Hepatol 2005;3:1047

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Katz P. Therapy of GERD: Nocturnal acid breakthrough in perspective. Practical Gastroenterology 2005; 12:57-62.

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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.

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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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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. Affect 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 BravoŽ 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.

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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.

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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.

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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.

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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.

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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.

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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 delayed0release tablets in reducing nighttime gastric acidity in GERD patients. Poster presentation at: 69th American College of Gastroenterology annual scientific meeting, October 2004; Orlando, FL.

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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.

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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.

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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.

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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. Poster Presented at: Digestive Disease Week; May 2006; Los Angeles, CA.

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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.

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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.

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About ZEGERID | Is ZEGERID Right For Your Patients? | Patient Tools
Physician Resources | Important Safety Information

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 13 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.