Label Changes for:

Protonix (pantoprazole sodium) For Delayed-Release Oral SuspensionProtonix (pantoprazole sodium) Delayed-Release Tablets

May 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012

 

 

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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