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What is ZEGERID?
ZEGERID contains omeprazole, a proton pump inhibitor, and sodium bicarbonate, an antacid which raises the gastric pH and thus protects omeprazole from acid degradation. ZEGERID is the First and only Immediate-Release oral proton pump inhibitor.

What are the approved indications for ZEGERID?
ZEGERID Capsules and Powder for Oral Suspension have been approved by the Food and Drug Administration (FDA) for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD); for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy; for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months); for short-term treatment of active duodenal ulcer (4-8 weeks); and for short-term treatment (4-8 weeks) of active benign gastric ulcer.

ZEGERID 40 mg/1680 mg Powder for Oral Suspension has also been FDA-approved for reduction of risk of upper gastrointestinal bleeding in critically ill patients. (The use of ZEGERID in critically ill patients beyond 14 days has not been evaluated.)

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 packets are not equivalent to, and should not be substituted for, one 40 mg packet.

Please refer to the ZEGERID package insert for full Prescribing Information1.

Can ZEGERID be used in pediatric patients?
While ZEGERID has not been studied in pediatric patients, the safety and effectiveness of another omeprazole product, omeprazole delayed-release capsules, have been established in pediatric patients from 2- to 16-years old for the treatment of acid-related disorders, including symptomatic GERD and erosive esophagitis. A physician should determine whether ZEGERID is appropriate for pediatric patients.

Can ZEGERID be used in geriatric patients?
Yes. Please see ZEGERID full Prescribing Information for more information.1

What are the advantages of ZEGERID?
ZEGERID is the First and only Immediate-Release Oral PPI

  • Now available in a capsule, and also in a powder for oral suspension
    • Both are immediate release formulations

ZEGERID offers a distinct pharmaco profile

  • Rapidly reaches peak plasma levels in ~30 minutes1
  • Provides 24-hour acid control1
    • Median values for the time gastric pH > 4 for patients taking ZEGERID Powder for Oral Suspension 20 mg and 40 mg doses, and Capsules 20 mg and 40 mg doses, ranged from 12.2 to 18.6 hours on Day 7.

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

ZEGERID effectively controls nighttime acid2 through the critical hours of the night.

What is the important safety information for ZEGERID?
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID and with the comparator (acid-controlling) drug. 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 303 mg of sodium per dose in the form of sodium bicarbonate (1100 mg/13 mEq), and 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.

How does ZEGERID differ from other PPIs?
All other oral PPIs are formulated as enteric-coated granules or tablets.3-7 The enteric coating protects the active drug from acid degradation in the stomach but delays release. ZEGERID is the first and only Immediate-Release (non-enteric-coated) oral PPI formulation.

What is the sodium content in ZEGERID?
One ZEGERID Capsules contains 303 mg of sodium in the form of sodium bicarbonate.

One unit-dose packet of ZEGERID Powder for Oral Suspension contains 460 mg of sodium in the form of sodium bicarbonate.

Is ZEGERID safe for use in all patients?
Please see ZEGERID full Prescribing Information for information about specific patient populations.

How is ZEGERID taken?
ZEGERID should be taken on an empty stomach at least 1 hour before a meal.1

ZEGERID Capsules directions for use: ZEGERID Capsules should be swallowed intact with DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD OR WATER.

ZEGERID Powder for Oral Suspension directions for use:
The contents of a single-dose packet should be emptied into a small cup containing one to two (1-2) tablespoons of water. The powder and water should be stirred well and the resulting suspension should be drunk immediately. The cup should be refilled with one to two (1-2) tablespoons of water to remove any residual powder and consumed. Other liquids or foods should not be used to suspend ZEGERID powder for dosing.

What is the stability of ZEGERID Powder for Oral Suspension once it is mixed with water?
ZEGERID Powder for Oral Suspension should be mixed and consumed immediately upon opening the packet. ZEGERID Suspension should not be stored.

How is a prescription for ZEGERID to be written?
ZEGERID 40 mg Powder for Oral Suspension #30
1 po QD as directed

ZEGERID 20 mg Powder for Oral Suspension #30
1 po QD as directed

ZEGERID 40 mg Capsule #30
1 po QD as directed

ZEGERID 20 mg Capsule #30
1 po QD as directed

What is the taste of ZEGERID Powder for Oral Suspension?
ZEGERID Powder for Oral Suspension has a peach/mint flavoring.

What sweeteners (sugars) are used in ZEGERID?
ZEGERID Capsules contain no sweeteners.
ZEGERID Powder for Oral Suspension contains the sugars: sucrose, sucralose, and xylitol.1

Is ZEGERID appropriate for patients with diabetes?
A physician should determine whether ZEGERID is appropriate for a patient with diabetes.

What is the half-life of ZEGERID?
In healthy subjects, the mean plasma half-life is 1 hour (range 0.4 to 3.2 hours). However, ZEGERID has a long duration of action due to apparent irreversible binding to the parietal cell.1

Can ZEGERID be administered via nasogastric or orogastric tube or syringe?
Yes. ZEGERID Powder for Oral Suspension has been approved to be administered via nasogastric or orogastric tube. To administer ZEGERID Powder for Oral Suspension through a nasogastric or orogastric tube, the powder should be constituted with approximately 20 mL of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and administer immediately. An appropriately sized syringe should be used to instill the suspension into the tube. The suspension should be washed through the tube with an additional 20 mL of water.

For patients receiving continuous NG/OG tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of ZEGERID.1

How is ZEGERID packaged?
ZEGERID Capsules is available in bottles of 30 capsules.

ZEGERID Powder for Oral Suspension is supplied in single-dose packets.

Is ZEGERID available over the counter (OTC)?
No, ZEGERID is available only by prescription.

How can I obtain more in-depth medical information about ZEGERID?
If you are a healthcare professional call 1-888-778-0887, or to submit a Medical Information Request, please click here.


References:
1. ZEGERID Prescribing Information. Santarus, Inc. February 2006.
2. Castell D, Bagin R, Goldlust B, Major J, Hepburn B. Comparison of the effects of immediate-release omeprazole powder for oral suspension and pantoprazole delayed-release tablets on nocturnal acid breakthrough in patients with symptomatic gastro-oesophageal reflux disease. Ailment Pharmacol Ther. 2005;21:1467-1474.
3. Aciphex Prescribing Information. Eisai Inc. and Janssen Pharmaceutica Inc. August 2003.
4. Nexium Prescribing Information. AstraZeneca Group of Companies. March 2003.
5. Prevacid Prescribing Information. Tap Pharmaceutical Productss Inc. November 2003.
6. Prilosec Prescribing Information. AstraZeneca Group of Companies. March 2003.
7. Protonix Prescribing Information. Wyeth Laboratories. June 2004.

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.