Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Gastroenterology | Family Medicine | Hepatology (Liver, Pancreatic, Gall Bladder)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Astra Merck
Approval Status: Approved March 1996
Treatment Area: gastric ulcers
Prilosec has been approved as a short-term treatment for active
benign gastric ulcers.
The first of a class of medications called proton pump
inhibitors, Prilosec targets acid production at its source, slowing
production of acid from the cells of the stomach lining.
In clinical trials of subject’s with endoscopically diagnosed
gastric ulcer, 85% of subjects with ulcers healed at week eight
Prilosec is generally well tolerated; side effects, which are
usually mild and transient, include headache, diarrhea, abdominal
pain, and nausea.
An ulcer is a lesion that forms in the lining of the stomach or
the duodenum (the upper part of the small intestine). Recent
research shows that most gastric ulcers develop as a result of
infection with bacteria called Helicobacter pylori (H. pylori). The
bacteria produces substances that weaken the stomach's
protective mucus and make the stomach more susceptible to damaging
effects of acid and pepsin.
Gastric ulcers are found throughout the stomach, but most
commonly along the lesser curvature of the stomach. They tend to be
larger in size and carry a higher mortality rate than duodenal
About 20 million Americans develop at least one peptic ulcer
during their lifetime. Each year, ulcers affect about five million
people, with more than one million hospitalized for the
In addition to the indication for gastric ulcers, Prilosec is
also used as short-term treatment of duodenal ulcers, erosive
esophagitis, and poorly responsive symptomatic gastroesophageal
reflux disease. It is also indicated to maintain healing of erosive
esophagitis, and for the long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison