Label Changes for:
Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets
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
- 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...