Protonix (pantoprazole sodium) Delayed-Release Tablets

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 esophageal diseases.

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:

• Diarrhea
• Rash
• Hyperglycemia
• Flatulence

Safety and effectiveness in pediatric patients have not yet been established.

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.

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)

Visit the Wyeth-Ayerst 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: www.gerd.com