PRILOSEC SUMMARY
The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted
benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1Hbenzimidazole, a compound that inhibits gastric acid secretion.
PRILOSEC is indicated for the following:
Duodenal Ulcer
PRILOSEC Delayed-Release Capsules are 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.
PRILOSEC Delayed-Release Capsules, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori.
PRILOSEC Delayed-Release Capsules, in combination with clarithromycin, are indicated for treatment
of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see
CLINICAL PHARMACOLOGY, Clinical Studies and DOSAGE AND ADMINISTRATION).
Among patients who fail therapy, PRILOSEC with clarithromycin is more likely to be associated with
the development of clarithromycin resistance as compared with triple therapy. In patients who fail
therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or
susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. (See
Microbiology section, and the clarithromycin package insert, MICROBIOLOGY section.)
Gastric Ulcer
PRILOSEC Delayed-Release Capsules are 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
PRILOSEC Delayed-Release Capsules are indicated for the treatment of heartburn and other
symptoms associated with GERD.
Erosive Esophagitis
PRILOSEC Delayed-Release Capsules are 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 PRILOSEC 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
PRILOSEC Delayed-Release Capsules are indicated to maintain healing of erosive esophagitis.
Controlled studies do not extend beyond 12 months.
Pathological Hypersecretory Conditions
PRILOSEC Delayed-Release Capsules are indicated for the long-term treatment of pathological
hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic
mastocytosis).
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