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Proven Nighttime acid control


Research has demonstrated that acid reflux is significantly more frequent in the first half of the nighttime period in patients with abnormal reflux.

In one pharmacodynamic study (Katz et al, 2007)

Evaluating nocturnal acidity with a bedtime QD dose (10 pm) of ZEGERID 40 mg Powder for Oral Suspension*, esomeprazole 40mg capsule, and lansoprazole 30mg capsule.

The goal of antisecretory therapy is to maintain gastric pH>4.

Nighttime acid reflux disease control chart Nighttime acid reflux disease control 10pm-4am

ZEGERID maintained gastric pH>4 for 63% (median) of the night throughout the 10 pm to 4 am period vs. 47% and 27%, esomeprazole and lansoprazole respectively.

In 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 dose of pantoprazole 40mg tablet.

Nighttime acid reflux disease control 10pm-6am

ZEGERID maintained gastric pH > 4 for 55% (median) of the 10pm to 6am period vs 27% for pantoprazole.

The goal of acid suppressive therapy for GERD and erosive esophagitis is to maintain intragastric pH>4.

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

ZEGERID should be used only for the conditions, dosages, and durations specified in the full prescribing information.

*Randomized, open-label, 7-day crossover study (N=49) to evaluate 3 proton pump inhibitors (PPIs) on nighttime gastric acidity in patients with nighttime symptoms of GERD.

† Powder for oral suspension.

§Randomized, open-label, 7-day crossover study (N=32) to evaluate 2 proton pump inhibitors (PPIs) on nighttime gastric acidity.

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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.