Omeprazole 40 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Omeprazole is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of active duodenal ulcer Omeprazole delayed-release capsules 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. 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole 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 in adults. Dual Therapy Omeprazole 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 in adults. 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 Clinical Pharmacology (12.4) and the clarithromycin prescribing information, Microbiology section ] . 1.3 Treatment of Active Benign Gastric Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. 1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older. 1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD Pediatric Patients 2 Years of Age to Adults Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older. The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE 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 EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered. 1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older. Controlled studies do not extend beyond 12 months. 1.7 Pathological Hypersecretory Conditions Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Aurobindo Pharma Limited
CAPSULE BROWN E 69
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16 HOW SUPPLIED/STORAGE AND HANDLING
OMEPRAZOLE Delayed-Release capsules USP, 10 mg are pink/pink size ‘3’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on pink cap and ‘65’ on pink body with black ink. Bottles of 30 NDC 59651-001-30 Bottles of 100 NDC 59651-001-01 Bottles of 1,000 NDC 59651-001-99 3 x 10 Unit-dose capsules NDC 59651-001-03 10 x 10 Unit-dose capsules NDC 59651-001-78
OMEPRAZOLE Delayed-Release capsules USP, 20 mg are reddish brown/pink size ‘1’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on reddish brown cap and ‘67’ on pink body with black ink. Bottles of 30 NDC 59651-002-30 Bottles of 90 NDC 59651-002-90 Bottles of 100 NDC 59651-002-01 Bottles of 500 NDC 59651-002-05 Bottles of 1,000 NDC 59651-002-99 3 x 10 Unit-dose capsules NDC 59651-002-03 10 x 10 Unit-dose capsules NDC 59651-002-78
OMEPRAZOLE Delayed-Release capsules USP, 40 mg are reddish brown/reddish brown size ‘0’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on reddish brown cap and ‘69’ on reddish brown body with black ink. Bottles of 30 NDC 59651-003-30 Bottles of 90 NDC 59651-003-90 Bottles of 100 NDC 59651-003-01 Bottles of 500 NDC 59651-003-05 Bottles of 1,000 NDC 59651-003-99 3 x 10 Unit-dose capsules NDC 59651-003-03 10 x 10 Unit-dose capsules NDC 59651-003-78 Storage Store
OMEPRAZOLE delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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