Duodenal Ulcer

ZEGERID is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

Gastric Ulcer

ZEGERID is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. (See CLINICAL PHARMACOLOGY, Clinical Studies, Gastric Ulcer.)

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD

ZEGERID is indicated for the treatment of heartburn and other symptoms associated with GERD.

Erosive Esophagitis

ZEGERID is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

The efficacy of ZEGERID used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis

ZEGERID is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.

Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients

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

ZEGERID (omeprazole/sodium bicarbonate) is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths for adult use. Directions for use for each indication are summarized in Table 14.

Since both the 20 mg and 40 mg oral suspension packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not equivalent to one packet of ZEGERID 40 mg; therefore, two 20 mg packets of ZEGERID should not be substituted for one packet of ZEGERID 40 mg.

Since both the 20 mg and 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to one capsule of ZEGERID 40 mg; therefore, two 20 mg capsules of ZEGERID should not be substituted for one capsule of ZEGERID 40 mg.

ZEGERID should be taken on an empty stomach at least one hour before a meal.

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

Table 14: Recommended Doses of ZEGERID by Indication for Adults 18 Years and Older

Administration of Capsules

ZEGERID Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

Preparation and Administration of Suspension

Directions for use: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.

If ZEGERID is to be administered through a nasogastric or orogastric tube, the suspension 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 in the tube. The suspension should be washed through the tube with 20 mL of water.

ZEGERID 20-mg Capsules: Each opaque, hard gelatin, colored light blue and white capsule, imprinted with the Santarus logo and "20", contains 20 mg omeprazole and 1100 mg sodium bicarbonate.

NDC 68012-102-30 Bottles of 30 capsules

ZEGERID 40-mg Capsules: Each opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and "40", contains 40 mg omeprazole and 1100 mg sodium bicarbonate.

NDC 68012-104-30 Bottles of 30 capsules

ZEGERID Powder for Oral Suspension is a white, flavored powder packaged in unit-dose packets. Each packet contains either 20 mg or 40 mg omeprazole and 1680 mg sodium bicarbonate.

NDC 68012-052-30 Cartons of 30: 20-mg unit-dose packets NDC 68012-054-30 Cartons of 30: 40-mg unit-dose packets

Storage

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). [See USP Controlled Room Temperature].

ZEGERID® Capsules are manufactured for Santarus, Inc., San Diego, CA 92130 by OSG Norwich Pharmaceuticals, Inc., North Norwich, NY 13814. ZEGERID® Powder for Oral Suspension is manufactured for Santarus, Inc. by Patheon Inc., Whitby, Ontario L1N 5Z5, Canada. For more information call 1-888-778-0887. Revised: July 2007. ZEGERID® is a registered trademark of Santarus, Inc. FDA Rev date: 12/21/2007.

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