1 INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for:
Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2)
Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3) and maintenance of healing of erosive esophagitis (1.4)
The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. (8.4)
1.1 Duodenal Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an
additional four weeks of therapy.
Omeprazole delayed-release capsules, USP, 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 in adults.
Omeprazole delayed-release capsules, USP, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and
duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see
Clinical Studies (14.1) and
Dosage and
Administration (2)].
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are 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 (12.4)], and the clarithromycin package insert, Microbiology section.)
1.2 Gastric Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults [see Clinical Studies (14.2)].
1.3 Treatment of Gastroesophageal Reflux Disease
(GERD) (adults and pediatric patients)
Symptomatic GERD
Omeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.
Erosive Esophagitis
Omeprazole delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults
[see
Clinical Studies (14.4)].
The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an
additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4 to 8 week courses of omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)
Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
Controlled studies do not extend beyond 12 months [see
Clinical Studies (14.4)].
1.5 Pathological Hypersecretory Conditions (adults)
Omeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas
and systemic mastocytosis) in adults.