Label Changes for:
Aciphex (rabeprazole sodium) Delayed-Release 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
5.8 Concomitant use of ACIPHEX with Methotrexate
- New section 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 and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted. [see Warnings and Precautions (5.8)].
