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

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Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)

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Maintenance of Healing of Erosive Esophagitis (1.2)

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Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3)

See full prescribing information for administration instructions

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Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)

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For Delayed-Release Oral Suspension: 40 mg pantoprazole (3)

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Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4)

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Patients receiving rilpivirine-containing products (4,7)

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Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)

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Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2)

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Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. (5.3)

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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)

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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)

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Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation. (5.6)

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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)

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Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. (5.8)

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Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. (5.10)

Most common adverse reactions are:

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For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6.1)

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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.

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

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