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Clinical Trials

Protonix (pantoprazole sodium) Intravenous Formulation

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved March 2001

Specific Treatments:

Gastroesophageal reflux disease

General Information

An intravenous (IV) formulation of Protonix (pantoprazole sodium) has been approved by the FDA for the short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) as an alternative to oral therapy in patients who are unable to continue taking Protonix Delayed-Release Tablets. Protonix IV is the first intravenous formulation available in the United States of the gastrointestinal drug class known as proton pump inhibitors. Currently, physicians use intravenous H2 antagonists to manage patients unable to take oral therapies.

Proton pump inhibitors work by targeting (H+,K+)-ATPase, an enzyme located on gastric (stomach) parietal cells. Protonix inhibits or blocks (H+,K+)-ATPase by forming a bond to two sites of the enzyme system, and as a result, suppresses the final step in gastric acid production.

GERD is a chronic condition caused by the reflux (reverse flow) of stomach acid into the esophagus. More than 40% of adults - nearly 60 million Americans - experience symptoms of GERD (typically a burning pain behind the breastbone) two or more times per week. According to an American Gastroenterology Association National survey, nearly 50 million Americans experience nighttime heartburn. If left untreated or uncontrolled, esophageal damage caused by GERD may lead to even more serious complications, including hemorrhage, Barrett's esophagus and esophageal cancer.

Clinical Results

Protonix has been evaluated in more than 100 trials worldwide, involving more than 45,000 subjects. Protonix IV has been used in more than 1.3 million subjects worldwide and is approved in 43 countries.

Side Effects

The most frequently reported adverse events with Protonix IV use include (but are not limited to) the following:

  • Abdominal pain
  • Chest pain
  • Rash
  • Pruritus (itching skin)

Protonix is contraindicated in patients with known hypersensitivity to any component of the formulation.

Because Protonix IV is indicated as an alternative to oral therapy for patients who are unable to continue taking the tablet form, treatment with Protonix IV should be discontinued as soon as the patient is able to be treated with Protonix Delayed-Release Tablets.

Mechanism of Action

Pantoprazole is a proton pump inhibitor 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 the 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. (Protonix Prescribing Information)

Additional Information

For additional information on all Protonix products, please visit Wyeth-Ayerst.

Additionally, more information on GERD can be obtained at the National Institute of Diabetes & Digestive & Kidney Diseases.

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