Protonix (pantoprazole sodium) Delayed-Release Tablets
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD)
Protonix is an acid suppressant indicated for the short-term
treatment (up to eight weeks) in the healing and symptomatic relief
of erosive esophagitis associated with GERD. An additional 8-week
treatment with Protonix may be considered if healing has not
commenced after the first 8 week treatment period.
Protonix has been shown to relieve both daytime and
night-time heartburn. It is effective when stomach acids exceed a
certain level: pH less than 4.
Esophagitis may be caused by irritation of the esophagus due to
acid reflux from the stomach to the esophagus. Although 36% of
healthy Americans experience this sort of reflux at least once a
month, perhaps up to 10% of American adults suffer from GERD on a
daily basis. Erosive esophagitis can be a precursor to more serious
In a US, multi-center double-blind, placebo-controlled study,
Protonix was administered in 10 mg, 20 mg, or 40 mg doses once
daily in patients with reflux symptoms and endoscopically diagnosed
erosive esophagitis (EE) of grade 2 or above (Hetzel-Dent scale).
All three dosages yielded significantly better healing rates than
the placebo. The 40 mg dose resulted in better healing rates than
the 20 mg or 10 mg doses. Patients taking the 40 mg dose
experienced complete cessation of heartburn and consumed
significantly fewer antacid tablets per day starting on the first
day of treatment.
Another clinical research study compared 20 mg and 40 mg once
daily doses of Protonix with nizatidine 150 mg twice daily.
Nizatidine is a histamine H2-blocker indicated for ulcers and other
gastric disorders. Results of this study indicated that both doses
of Protonix yielded significantly superior rates of healing at both
4 and 8 weeks compared with the twice daily dose of nizatidine.
Patients taking Protonix also experienced relief of heartburn
faster and took significantly fewer antacid tablets per day than
those taking nizatidine.
Clinical results also indicated that Protonix is effective in
preventing relapse of EE.
In general, pantoprazole was well tolerated in clinical studies.
Adverse effects were not dose related. The following side effects
were experienced by 1% or more of patients taking Protonix and had
incidence greater than placebo and/or nizatidine:
Safety and effectiveness in pediatric patients have not yet been
No dosage adjustment is recommended based on age, renal
impairment, or for patients undergoing hemodialysis.
Safety and effectiveness for long-term treatment (greater than
16 weeks) has not yet been determined.
Mechanism of Action
Pantoprazole is a proton pump inhibitor (PPI) that suppresses
the final step in gastric acid production by forming a covalent
bond to two sites of the (H+, K+)-ATPase enzyme system at the
secretory surface of the gastric parietal cell. This effect is
dose-related and leads to inhibition of both basal and stimulated
gastric acid secretion irrespective of the stimulus. The binding to
the (H+, K+)-ATPase results in a duration of antisecretory effect
that persists longer than 24 hours. (From FDA Label)
Laboratories web site to learn about other products, research,
and services provided by the company that developed this drug.
For more information about GERD and erosive esophagitis, visit
the GERD Information Resource Center, sponsored by AstraZeneca LP: