오메라졸캡슐(오메프라졸)

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 …

• Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ), Adverse Reactions (6) ]. • Proton pump inhibitors (PPIs), including omeprazole, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ]. • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts. • Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. (4) • Patients receiving rilpivirine-containing products. ( 4 , 7 ) • Refer to the Contraindications section of the prescribing …

• Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1) • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2) • Clostridium difficile-Associated Diarrhea :PPI therapy may be associated with increased risk. (5.3) • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4) • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue omeprazole and refer to specialist for evaluation (5.6) • Interaction with Clopidogrel: Avoid concomitant use of omeprazole. ( 5.7 , 7 ) • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.8 ) • Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.9) • Interaction with St. John’s Wort or Rifampin: Avoid concomitant use of omeprazole. ( 5.10 , 7 ) • Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased Chromogranin A (CgA) levels may interfere with diagnostic …

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with …