Critically Ill Patients

The only PPI with FDA approval for reduction of risk of upper GI bleeding in critically ill patients

ZEGERID* Powder for Oral Suspension 40 mg rapidly achieved gastric pH>4 with the first dose, regardless of baseline pH.

Initial effect of ZEGERID

ZEGERID omeprazole effect on the critically ill

Data from a multicenter, randomized, double-blind, controlled, up to 14-day study in a total of 359 mechanically ventilated patients (178 patients treated with ZEGERID; 177 patients treated with IV cimetidine). ZEGERID oral suspension was administered twice on Day 1 (doses administered 6 to 8 hours apart) then once daily via nasogastric/orogastric tube.

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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.