Product Description.:
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capsule , gelatin coated , blue white , oblong oblong
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ZEGERID? (omeprazole/sodium bicarbonate) is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion.
Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155?C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
ZEGERID is supplied as immediate-release capsules and unit-dose packets as powder for oral suspension. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate with the following excipients: xylitol, sucrose, sucralose, xanthan gum, and flavorings.
INDICATIONS
Duodenal Ulcer
ZEGERID (omeprazole/sodium bicarbonate) 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. [See Clinical Studies]
Gastric Ulcer
ZEGERID is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies]
Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
ZEGERID is indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies]
Erosive Esophagitis
ZEGERID is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of ZEGERID used for longer than 8 weeks in these patients has not been established. If a patient does not respond 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 (e.g., heartburn), additional 4-8 week courses of ZEGERID may be considered. [See Clinical Studies]
Maintenance of Healing of Erosive Esophagitis
ZEGERID is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies]
Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40mg oral suspension only)
ZEGERID Powder for Oral Suspension 40 mg/1680 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients. [See Clinical Studies, Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients]
