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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)
Post marketing Experience
- agranulocytosis, pancytopenia and taste disorders (ageusia, dyseusia)
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
- Case reports, published population suggest that concomitant administration of PPIs and methotrexate .....