Label Changes for:

Nexium I.V. (esomeprazole sodium) for injection

December 2014

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)  

December 2014

CONTRAINDICATIONS

  • ‚ĶHypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria

WARNINGS AND PRECAUTIONS

Acute Interstitial Nephritis

*Section Added

DRUG INTERACTIONS

*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
 

 

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.....

 

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