Aciphex (rabeprazole sodium) Delayed-Release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
8 USE IN SPECIFIC POPULATIONS
- The pregnancy category has also been changed from a B to a C.
5 WARNINGS AND PRECAUTIONS
5.8 Concomitant use of ACIPHEX with Methotrexate
- New section 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 and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted. [see Warnings and Precautions (5.8)].