Safety

Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension and Delayed-Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

December 2014

Summary View

CONTRAINDICATIONS

  • …Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria

WARNINGS AND PRECAUTIONS

Acute Interstitial Nephritis

*Section Added

DRUG INTERACTIONS

*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil  

 

December 2013

Summary View

ADVERSE REACTIONS

Post marketing Experience
  • agranulocytosis, pancytopenia and taste disorders (ageusia, dyseusia)

 

May 2012

Summary View 

5 WARNINGS AND PRECAUTIONS

5.8 Concomitant use of PROTONIX with Methotrexate
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose .....

7 DRUG INTERACTIONS

7.6 Methotrexate
  • Case reports, published population suggest that concomitant administration of PPIs and methotrexate .....

 

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