Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Gastroenterology | Family Medicine
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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 December 1996
Treatment Area: symptoms associated with gastroesophageal reflux disease (GERD)
Prilosec has been approved for the treatment of heartburn and
other symptoms associated with gastroesophageal reflux disease
(GERD). The recommended adult dose is 20 mg daily for up to four
weeks in patients with symptomatic GERD.
In addition to its new indication, Prilosec is also indicated
for use in combination with the antibiotic Biaxin for the
eradication of H. pylori infection associated with duodenal ulcers
to reduce the risk of recurrence. H. Pylori is the bacterium now
believed to cause approximately 90% of peptic ulcers. Prilosec is
also indicated as first-line therapy for erosive esophagitis, for
the maintenance of healed erosive esophagitis, for short-term
treatment of active duodenal ulcer, and active benign gastric
ulcer. It is also indicated for the treatment of certain
pathological hypersecretory conditions.
Prilosec is generally well tolerated; side effects, which are
usually transient and mild, include headache, diarrhea, abdominal
pain and nausea.
Although many people experience heartburn from time to time,
patients who get heartburn more than two to three times a week may
have a more serious condition called GERD, an acid-related disorder
affecting approximately 19 million Americans. GERD results when the
lower esophageal sphincter, the muscle between the stomach and the
esophagus, or food tube, relaxes allowing harsh stomach acid to
splash back into the esophagus. GERD is a potentially serious
medical condition, which can lead to significant complications,
including ulcers, narrowing of the esophagus, and precancerous
changes within the lining of the esophagus.
Because heartburn is the most common symptom of GERD, the
disease is often misunderstood and underestimated by patients and
doctors. Prilosec significantly reduces acid directly at the final
site of acid production, the acid pumps in the cells of the