Protonix I.v.

Protonix I.v.

Protonix I.v. Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis

PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated.

1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome

PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults.

History

There is currently no drug history available for this drug.

Other Information

Therapeutic class: Proton Pump Inhibitor (PPI)

Route of administration: For Intravenous use only

The active ingredient in PROTONIX® I.V. (intravenous pantoprazole sodium) for Injection is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is:

Chemcial Structure

Pantoprazole sodium is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of PROTONIX I.V. for Injection is in the pH range 9.0 to 10.5.

PROTONIX I.V. for Injection is supplied as a freeze-dried powder in a clear glass vial fitted with a rubber stopper and crimp seal containing pantoprazole sodium, equivalent to 40 mg of pantoprazole, edetate disodium (1 mg), and sodium hydroxide to adjust pH.

Protonix I.v. Manufacturers


  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]
  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]
  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]
  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]
  • Cardinal Health
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Cardinal Health]
  • Cardinal Health
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Cardinal Health]
  • Cardinal Health
    Protonix I.v. (Pantoprazole Sodium) Injection, Powder, For Solution [Cardinal Health]

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