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Freebase Commons Common /common

  • Omeprazole (Kremers Urban Pharmaceuticals), manufactured drug form of Omeprazole, 20mg/capsule omeprazole delayed release capsule, NDC 62175-118

Freebase Commons Business /business

Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
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  • 43683-2
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  • Omeprazole Delayed-Release Capsules are 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 Delayed-Release Capsules in pediatric patients < 1 year of age have not been established (8.4).
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  • Omeprazole Delayed-Release Capsules, 10 mg, 20 mg and 40 mg (3)
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  • Known hypersensitivity to any component of the formulation or substituted benzimidazoles (angioedema and anaphylaxis have occurred) (4)
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  • Symptomatic response does not preclude the presence of gastric malignancy ( 5.1). Atrophic Gastritis: has been noted with long-term therapy (5.2). Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increaded risk for osteoporosis-related fractures of the nip, wrist, or spine (5.3). Diminished anti-platelet activity of clopidogrel due to impaired CYP2C19 function by 80 mg omeprazole (5.4). Triple therapy for H. pylori – there are risks due to antibiotics; see separate prescribing information for individual antibiotics (5.5, 5.6). Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.7). Avoid concomitant use of Omeprazole Delayed-Release Capsules with St. John's Wort or rifampin due to the potential reduction in omeprazole concentrations (5.8, 7.3). Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased Chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors (5.9, 12.2).
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  • Adults: Most common adverse reactions in adults (incidence > 2%) are Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence (6) Pediatric patients (2 to 16 years of age): Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies (8.4). To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. (1-866-822-0068) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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  • Patients with hepatic impairment: Consider dose reduction, particularly for maintenance of healing of erosive esophagitis (12.3).
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  • 34089-3

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