Label Changes for:

Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg

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

5.9 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

7.7 Methotrexate
  • 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.....

MEDICATION GUIDE

Tell your healthcare provider about all the medicines you take.....

Especially tell your healthcare provider if you take:

  • Erlotinib ....added
Hide
(web5)