ZEGERID SUMMARY
The active ingredient in ZEGERID™ (omeprazole) powder for oral suspension, is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1
H
-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion.
ZEGERID™ is indicated for the following:
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.
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 (e.g. heartburn), additional 4-8 week courses of omeprazole may be considered.
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
ZEGERID™ Powder for Oral Suspension is indicated to maintain healing of erosive esophagitis.
Controlled studies do not extend beyond 12 months.
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