Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Gastroenterology | Family Medicine
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Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Astra Merck, Abbott Laboratories
Approval Status: Approved April 1996
Treatment Area: duodenal ulcers
Prilosec in combination with Biaxin has been approved for the
treatment of subjects with H. pylori infection and duodenal ulcer
to eradicate H. pylori, the bacteria now believed to cause
approximately 90% of peptic ulcers. H. pylori eradication has been
shown to reduce the risk of duodenal ulcer recurrence. Prilosec is
marketed by Astra Merck and Biaxin is marketed by Abbott
The recommended dosage for eradicating H. pylori is Prilosec 40
mg once daily and Biaxin 500 mg three times daily for the first 14
days, followed by Prilosec 20 mg once daily for days 15 to 28.
In clinical trials, the combination of Prilosec and Biaxin had
H. pylori eradication rates of up to 83%. Among subjects in whom H.
pylori has been eradicated, ulcer recurrence rates have been as low
as five percent six months after therapy.
The Prilosec-Biaxin regimen has been generally well tolerated:
side effects, which are usually mild and transient included taste
perversion, nausea, and headache.
Peptic ulcers affect approximately five million Americans each
year. It is estimated that 10% of the population will develop an
ulcer during their lifetime. In the past, ulcers were believed to
be caused by lifestyle factors such as stress and diet. Later,
researchers discovered that an imbalance between digestive fluids
and the stomach's ability to defend itself against these
powerful substances resulted in ulcers.
However, researchers now know that the H. pylori bacteria (along
with acid secretion) damages stomach and duodenal tissue, causing
inflammation and ulcers in 90% of ulcer subjects. Treatment with
Prilosec and Biaxin is considered a dramatic medical advance
because elimination of H. pylori means that the ulcer will not only
heal but also will not likely return.
H. pylori is a spiral-shaped bacterium found in the stomach.
Like most germs, H. pylori bacteria is thought to be transmitted
from person-to-person contact. Experts believe the activity of the
bacteria damages and weakens the barrier that protects the stomach
and duodenum, eventually causing the ulcer. In some people, the
infection persists lifelong. Infection with H. pylori has also been
linked to a number of other gastrointestinal diseases, including
An ulcer is a sore or lesion that forms in the lining of the
stomach or duodenum where acid and pepsin are present. Symptoms of
ulcers include a gnawing or burning pain in the upper abdomen
(often occurring between meals and early in the morning), and,
sometimes, nausea, vomiting, loss of appetite and weight. Although
ulcers can develop at any age, they are most prevalent in people
over the age of 30.
Prilosec is currently indicated as first-line therapy for
erosive esophagitis, for the maintenance of healed erosive
esophagitis, for symptomatic gastroesophageal reflux disease (GERD)
that is poorly responsive to customary medical treatment, and 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. Biaxin is indicated for the
treatment of mild-to-moderate infections, including
upper-respiratory tract infections, lower-respiratory tract
infections, and uncomplicated skin and skin-structure