Label Changes for:
Nexium (esomeprazole sodium) For Injection
January 2012
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012
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.....
7.3 Methotrexate
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily.....
