(pantoprazole sodium)

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Prescribing Information

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Highlights

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

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 Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (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)
•
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. (5.5)
•
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation. (5.6)
•
Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.7)
•
Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.8)
•
Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.10)

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: 6/2023

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