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Label Changes for:

Aciphex (rabeprazole sodium) Delayed-Release Tablets

December 2014

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

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

December 2014

CONTRAINDICATIONS

  • … is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria

WARNINGS AND PRECAUTIONS

Acute Interstitial Nephritis

*Section Added

Cyanocobalamin (vitamin B12) Deficiency

*Section added

DRUG INTERACTIONS

*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
 

 

October 2014

8 USE IN SPECIFIC POPULATIONS

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

 

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)].

 

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