Label Changes for:
Nexium I.V. (esomeprazole sodium) for injection
Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.
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
5 WARNINGS AND PRECAUTIONS
5.7 Concomitant use of NEXIUM with Methotrexate
- Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose;.....
6 ADVERSE REACTIONS
6.3 Postmarketing Experience
- microsopic colitis....added
7 DRUG INTERACTIONS
- Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, atazanavir, iron salts, and erlotinib can decrease.....
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily.....