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PROTONIX® IV Highlights (pantoprazole sodium for injection)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PROTONIX I.V. safely and effectively. See full prescribing information for PROTONIX I.V.

PROTONIX® I.V. (pantoprazole sodium) for injection, for intravenous use
Initial U.S. approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions,
 Severe Cutaneous Adverse Reactions (5.7)03/2022
 Hypomagnesemia and Mineral Metabolism (5.10)03/2022

INDICATIONS AND USAGE

PROTONIX is a proton pump inhibitor (PPI) indicated in adults for the following:

  • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1)
  • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2)

DOSAGE AND ADMINISTRATION

GERD Associated with EE (2.1)

  • The recommended adult dosage is 40 mg given once daily by intravenous infusion for 7 to 10 days. (2.1)

Pathological Hypersecretion Conditions, Including ZE Syndrome (2.3):

  • The recommended adult dosage is 80 mg administered every 12 hours by intravenous infusion. For information on how to adjust dosing for individual patient needs, see the full prescribing information.

Administration (2.2, 2.4):

  • Only for intravenous infusion.
  • The intravenous infusion can be administered over 2 minutes or 15 minutes.
  • For information on how to prepare and administer for each indication, see the full prescribing information.

DOSAGE FORMS AND STRENGTHS

  • For Injection: 40 mg pantoprazole freeze-dried powder in a single-dose vial for reconstitution. (3)

CONTRAINDICATIONS

  • Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. (4)
  • Patients receiving rilpivirine-containing products. (4,7)

WARNINGS AND PRECAUTIONS

  • Gastric Malignancy: In adults, symptomatic response to therapy with PROTONIX I.V. does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
  • Injection Site Reactions: Thrombophlebitis is associated with the administration of intravenous pantoprazole. (5.2)
  • Potential Exacerbation of Zinc Deficiency: Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. (5.3)
  • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.4)
  • Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.5)
  • Bone Fracture: Long term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.6)
  • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. (5.7)
  • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX I.V. and refer to specialist for evaluation. (5.8)
  • Hepatic Effects: Elevations of transaminases observed. (5.9)
  • Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.10)
  • Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.11)

ADVERSE REACTIONS

Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See the full prescribing information for a list of clinically important drug interactions (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2022

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