MedPath

Omeprazole

Generic Name
Omeprazole
Brand Names
Konvomep, Losec, Omeclamox, Omesec, Previdolrx Analgesic Pak, Prilosec, Talicia, Yosprala, Zegerid, Zegerid Reformulated Aug 2006, Zegerid With Magnesium Hydroxide
Drug Type
Small Molecule
Chemical Formula
C17H19N3O3S
CAS Number
73590-58-6
Unique Ingredient Identifier
KG60484QX9

Overview

Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .

Background

Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .

Indication

Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adults

Associated Conditions

  • Ankylosing Spondylitis (AS)
  • Duodenal Ulcer
  • Erosive Esophagitis
  • Gastric Ulcer
  • Gastro-esophageal Reflux Disease (GERD)
  • Healing
  • Heartburn
  • Helicobacter Pylori Infection
  • Osteoarthritis (OA)
  • Rheumatoid Arthritis
  • Upper GI Bleeding
  • Zollinger-Ellison Syndrome
  • Benign, active Gastric Ulcer
  • Develop NSAID-induced gastric ulcers
  • Hypersecretory conditions
  • Multiple endocrine adenomas

FDA Approved Products

Omeprazole
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2021/02/18
NDC:68071-4906
Omeprazole
Manufacturer:Strides Pharma Science Limited
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/05/04
NDC:64380-223
Omeprazole
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:20 mg in 1 1
Approved: 2022/02/15
NDC:50090-5901
Omeprazole
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2024/01/04
NDC:70518-0199
Omeprazole
Manufacturer:Preferred Pharmaceuticals Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2023/08/21
NDC:68788-6995

Singapore Approved Products

No Singapore products found for this drug

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