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Proven Nighttime Acid Control


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A pharmacodynamic study (Katz et al, 2007) evaluating nocturnal gastric acidity with a bedtime QD dose (10 pm) of ZEGERID 40 mg Powder for Oral Suspension, esomeprazole 40 mg capsule, and lansoprazole 30 mg capsule, demonstrated:1*

  • Rapid of control of nocturnal gastric pH compared to bedtime dosing of esomeprazole and lansoprazole⊥
Rapid release
  • Substantial reduction in proportion of patients who experience nocturnal acid breakthrough (gastric pH<4 for more than 1 continuous hour during the nighttime period)⊥
Continued control

Another pharmacodynamic study (Castell et al, 2005) evaluating nighttime gastric acidity with a bedtime QD dose (10 pm) of ZEGERID 40 mg Powder for Oral Suspension vs. an evening QD dose of pantoprazole 40 mg tablets, demonstrated:2†

  • Substantial nighttime acid control as measured by gastric pH>4 for a substantial percentage of the nighttime hours
Continued control

The correlation of pharmacodynamic data to clinical effects has not been established.

*Randomized, open-label, 7-day crossover study (N=49) to evaluate 3 PPIs on nighttime gastric acidity in patients with nighttime symptoms of GERD.
⊥In this study, lansoprazole was administered at 10 pm on an empty stomach; lansoprazole labeling recommends dosing before eating.
†Randomized, open-label, 7-day crossover study (N=32) to evaluate 2 PPIs on nighttime gastric acidity. ZEGERID was taken at bedtime on all days; pantoprazole was taken at bedtime on days 1 and 7 and prior to dinner on Days 2 through 6.


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References

  1. ZEGERID Prescribing Information. Santarus, Inc. April 26, 2007.
  2. Katz PI, Koch FK, et al. 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.
  3. Castell D. Review of immediate-release omeprazole for the treatment of gastric acid-related disorders. Expert Opin Pharmacother. 2005;6:2501-2510
  4. Wolters Kluwer Health Source™ Dynamic Claims™. Note a portion of these approvals may be reversed by the patient.

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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 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.