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PROTONIX® Highlights (pantoprazole sodium)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

PROTONIX (pantoprazole sodium) delayed-release tablets, for oral use
PROTONIX (pantoprazole sodium) for delayed-release oral suspension
Initial U.S. approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Fundic Gland Polyps (5.9) 06/2018

INDICATIONS AND USAGE

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

  • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
  • Maintenance of Healing of Erosive Esophagitis (1.2)
  • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3)

DOSAGE AND ADMINISTRATION

Indication Dose Frequency
*
Controlled studies did not extend beyond 12 months
Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1)
  Adults 40 mg Once Daily for up to 8 wks
  Children (5 years and older)
    ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks
    ≥ 40 kg 40 mg
Maintenance of Healing of Erosive Esophagitis (2.1)
  Adults 40 mg Once Daily*
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)
  Adults 40 mg Twice Daily

See full prescribing information for administration instructions

DOSAGE FORMS AND STRENGTHS

  • Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)
  • For Delayed-Release Oral Suspension: 40 mg pantoprazole (3)

CONTRAINDICATIONS

  • Patients with 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 does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
  • Acute Interstitial Nephritis: Observed in patients taking PPIs. (5.2)
  • Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. (5.3)
  • 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. (5.4)
  • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation. (5.5)
  • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.6)
  • Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. (5.7)
  • Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.9)

ADVERSE REACTIONS

Most common adverse reactions are:

  • For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)
  • For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. (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 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 and Medication Guide.

Revised: 4/2019

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch