DOSAGE AND ADMINISTRATION
ZEGERID (omeprazole/sodium bicarbonate) is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1. All recommended doses throughout the labeling are based upon omeprazole
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 Nasogastric (NG)/ Orogastric (OG) tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of ZEGERID Powder for Oral Suspension.
Table 1: Recommended Doses of ZEGERID by Indication for Adults 18 Years and Older
* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies ]
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** For additional information, [See Clinical Studies]
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+ For additional information, [See Indications and Usage (1)]
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Indication
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Recommended Dose
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Frequency
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Short-Term Treatment of Active Duodenal Ulcer
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20 mg
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Once daily for 4 weeks*,+
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Benign Gastric Ulcer
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40 mg
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Once daily for 4-8 weeks **,+
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Gastroesophageal Reflux Disease (GERD)
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Symptomatic GERD (with no esophageal erosions)
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20 mg
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Once daily for up to 4 weeks+
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Erosive Esophagitis
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20 mg
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Once daily for 4-8 weeks+
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Maintenance of Healing of Erosive Esophagitis
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20 mg
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Once daily**
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Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40 mg oral suspension only)
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40 mg
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40 mg initially followed by 40 mg 6-8 hours later and 40 mg daily thereafter for 14 days**
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Special Populations
Hepatic Insufficiency
Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology ]
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 (NG) or orogastric (OG) 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.
Use with clopidogrel
Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions and Drug Interactions (7)].
DOSAGE FORMS AND STRENGTHS
ZEGERID 20-mg Capsules: Each opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20”, contains 20 mg omeprazole and 1100 mg sodium bicarbonate.
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.
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.
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