Label Changes for:

Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets

May 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012

 

 

5 WARNINGS AND PRECAUTIONS

5.7 Concomitant use of Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide with Methotrexate
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate ...

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...
     
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