Safety

Aciphex (rabeprazole sodium) Delayed-Release Tablets

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

 

October 2014

Summary View

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
  • The pregnancy category has also been changed from a B to a C.

 

May 2012

Summary View

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)].

 

Page Last Updated: 11/17/2014
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