Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- … contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
Cyanocobalamin (vitamin B12) Deficiency
*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
5 WARNINGS AND PRECAUTIONS
5.9 Concomitant use of VIMOVO with Methotrexate
- Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate...
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- microsopic colitis....added
7 DRUG INTERACTIONS
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate.....
Tell your healthcare provider about all the medicines you take.....
Especially tell your healthcare provider if you take:
- Erlotinib ....added