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 .....
