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ZEGERID® (omeprazole/sodium bicarbonate) is the First and only Immediate- Release oral PPI. We have received FDA approval of ZEGERID for Capsules, Powder for Oral Suspension and Chewable Tablet* dosage forms. These products are intended to treat or prevent a variety of upper GI diseases and disorders. PPIs are used widely due to their potent acid suppression, demonstrated safety and once-a-day dosing.

We received FDA approval for ZEGERID Capsules in February of 2006, ZEGERID Powder for Oral Suspension 40 mg in December of 2004, ZEGERID Powder for Oral Suspension 20 mg in June of 2004, and ZEGERID with Magnesium Hydroxide Chewable Tablets 40 mg and 20 mg in March, 2006.

ZEGERID Capsules, Powder for Oral Suspension and Chewable Tablet* dosage forms are immediate-release formulations, providing rapid absorption of omeprazole and continued acid control. The immediate-release formulation of ZEGERID is unique. Except for ZEGERID, all other oral PPIs are delayed release, and require enteric coatings to protect against acid degradation. These enteric coatings delay absorption and initial acid suppression.

We have licensed exclusive, worldwide rights to patents and patent applications covering specific formulations of immediate-release PPIs and antacids for treating upper GI diseases and disorders from the University of Missouri. The initially issued U.S. patents on which our ZEGERID products are based, expire in July 2016.

ZEGERID (omeprazole/sodium bicarbonate) is indicated for:

Short-term treatment of active duodenal ulcer
Short-term treatment (4-8 weeks) of active benign gastric ulcer
Heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed in endoscopy
Maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months)
Reduction of risk of upper GI bleeding in critically ill patients (powder for oral suspension only)

ZEGERID Powder for Oral Suspension 40 mg/1680 mg is the only FDA approved PPI for reduction of risk of upper GI bleeding in critically ill patients.

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.

* NOTE: Zegerid Chewable Tablets are not currently marketed by Santarus.

Product Description
ZEGERID® (omeprazole/sodium bicarbonate) 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 QD); for the short-term treatment (4-8 weeks) of erosive esophagitis diagnosed by endoscopy (20 mg QD); for maintenance of healing of erosive esophagitis (20 mg QD) (controlled studies do not extend beyond 12 months); for short-term treatment (4-8 weeks) of active duodenal ulcer (20 mg QD); for short-term treatment (4-8 weeks) of active benign gastric ulcer (40 mg QD); and for reduction of risk of upper gastrointestinal bleeding in critically ill patients (only powder for oral suspension 40 mg/1680 mg QD; 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, but some adverse events occurred with more frequency in 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.

For the full Prescribing Information please visit www.zegerid.com

Please consult with your healthcare professional to see if ZEGERID is right for you. The content of this website is not a substitute for professional medical advice and should not be interpreted as treatment recommendations or relied on for medical diagnosis or treatment. Please see complete Legal Disclaimer.