Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- …Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
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 .....