Drug Detail:Zegerid (Omeprazole and sodium bicarbonate [ oh-me-pray-zol-and-so-dee-um-by-kar-bon-ate ])
Generic Name: OMEPRAZOLE 20mg, SODIUM BICARBONATE 1680mg
Drug Class: Proton pump inhibitors
Important Administration Instructions
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- ZEGERID (omeprazole and 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. All recommended doses throughout the labeling are based upon omeprazole.
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- The sodium content of ZEGERID capsules and ZEGERID for oral suspension should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]:
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- ZEGERID capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.
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- ZEGERID for oral suspension: each 20 mg and 40 mg packet of contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg.
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- Due to the sodium bicarbonate content of ZEGERID:
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- Two packets of 20 mg ZEGERID for oral suspension are not interchangeable with one packet of 40 mg ZEGERID for oral suspension.
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- Two 20 mg ZEGERID capsules are not interchangeable with one 40 mg ZEGERID capsule.
Dosage Regimen
The recommended dosage regimen by indication in adults of ZEGERID for oral suspension and ZEGERID capsules is summarized in Table 1. Only 40 mg ZEGERID for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2. All recommended dosages are based upon omeprazole content.
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Indication |
Dosage of ZEGERID for oral suspension or ZEGERID capsules |
Treatment Duration |
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Treatment of Active Duodenal Ulcer |
20 mg once daily |
4 weeks*† |
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Treatment of Active Benign Gastric Ulcer |
40 mg once daily |
4 to 8 weeks |
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Treatment of Symptomatic GERD |
20 mg once daily |
Up to 4 weeks |
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Treatment of EE due to Acid-Mediated GERD |
20 mg once daily |
4 to 8 weeks† |
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Maintenance of Healing of EE due to Acid-Mediated GERD |
20 mg once daily |
Controlled studies do not extend beyond 12 months. |
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Indication |
Dosage of 40 mg ZEGERID for oral suspension |
Treatment Duration |
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Reduction of Risk of Upper GI Bleeding in Critically Ill Patients |
40 mg initially; followed by |
14 days |
Preparation and Administration
ZEGERID Capsules
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- Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water.
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- Take on an empty stomach at least one hour before a meal [see Clinical Pharmacology (12.3)].
ZEGERID for Oral Suspension
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- ZEGERID for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube.
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- If administered orally, take on an empty stomach at least one hour before a meal.
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- If administered via NG or OG tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of ZEGERID for oral suspension.
Oral Administration
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- Empty the contents of a packet into a small cup containing 5 to 10 mL of water. Do not mix with liquids or foods other than water.
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- Stir well and drink immediately.
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- Refill cup with water and drink immediately.
Nasogastric (NG) or Orogastric (OG) Tube Administration
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- Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet. Use an appropriately-sized catheter tipped syringe. Do not mix with liquids or foods other than water.
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- Shake the syringe to dissolve the powder.
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- Administer through the NG or orogastric tube into the stomach right away.
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- Refill the syringe with an equal amount of water.
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- Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach.
