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.....
Hide
(web2)