Protonix (pantoprazole sodium) Delayed Release Tablets
Company: Wyeth Pharmaceuticals
Approval Status: Approved April 2002
Treatment for: Gastroesophageal disorders
Areas: Gastroenterology
Possible similar drugs: Protonix; Protonix
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
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, up to 10% of suffer from GERD on a daily basis. EE can be a precursor to more serious esophageal diseases.
Zollinger-Ellison Syndrome is a rare and potentially deadly disease that typically affects those between the ages of 30 and 50. It is caused by a neuroendocrine tumor, called a gastrinoma, located in the pancreas or duodenum. Due to the tumor, high levels of gastrin are circulated, which results in excessive levels of gastric acid secretion and leads to severe ulceration of the upper gastrointestinal tract. Such lack of control over acid levels may lead to serious complications.
Clinical Results
The approval Protonix for the treatment of EE associated with GERD is supported by two double-blind, placebo-controlled dose escalating studies with approximately 850 subjects with reflux symptoms and endoscopically diagnosed EE. All three dosages used yielded significantly better healing rates than placebo, with the 40 mg dose proving most effective. Subjects in that group experienced complete cessation of heartburn and consumed significantly fewer antacid tablets per day starting on the first day of treatment.Two randomized, double-blind, comparator-controlled trials were conducted in 790 GERD subjects with endoscopically-confirmed healed EE, to determine the effectiveness of Protonix in long-term maintenance of healing. Protonix 40 mg was significantly superior to the comparator at every time point for the maintenance of healing and for reduction in daytime and nighttime heartburn episodes.
Protonix's approval for the treatment of Zollinger-Ellison Syndrome is based on a multi-center trial with 35 subjects with Zollinger-Ellison Syndrome or another hypersecretory condition. Results showed that acid output was controlled for most subjects for up to six months and that at six months, 94% of subjects had responded to treatment.
Side Effects
Adverse events associated with the use of Protonix (pantoprazole) may include (but are not limited to) the following:- Diarrhea
- Rash
- Abdominal pain
- Flatulence
- Nausea
- Vomiting
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)Additional Information
For additional information on Protonix Delayed Release Tablets, please visit Protonix.The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
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