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
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
- 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.....
Tell your healthcare provider about all the medicines you take.....
Especially tell your healthcare provider if you take:
- Erlotinib ....added