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  5. Label Information: Pantoprazole Sodium Delayed Release

FDA Label for Pantoprazole Sodium Delayed Release

View Indications, Usage & Precautions

Table of Contents

    1. INDICATIONS AND USAGE
    2. WARNINGS AND PRECAUTIONS
    3. ADVERSE REACTIONS
    4. DRUG INTERACTIONS

Pantoprazole Sodium Delayed Release Product Label

The following document was submitted to the FDA by the labeler of this product Northwind Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Indications And Usage



Pantoprazole is a proton pump inhibitor indicated for the following:

•Short-term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD).

•Maintenance of Healing of Erosive Esophagitis.

•Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome.


Warnings And Precautions



•Symptomatic response does not preclude presence of gastric malignancy.

•Atrophic gastritis has been noted with long-term therapy.

•PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.

•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.

•Hypomagnesemia has been reported rarely with prolonged treatment with PPIs


Adverse Reactions



The most frequently occurring adverse reactions are as follows:

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

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


Drug Interactions



•Do not coadminister with atazanavir or nelfinavir.

•Concomitant warfarin use may require monitoring.

•May interfere with the absorption of drugs where gastric pH is important for bioavailability.

•May produce false-positive urine screen for THC.

•Methotrexate: Pantoprazole may increase serum level of methotrexate

Information describing use in pediatric patients with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.


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