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Label Changes for:

Dexilant (dexlansoprazole) delayed-release capsules

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

  • … Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole

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
 

 

May 2012

5 WARNINGS AND PRECAUTIONS

5.4 Concomitant Use of DEXILANT with Methotrexate
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7.5)].

7 DRUG INTERACTIONS

7.5 Methotrexate
  • Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate .....

 

 

October 2011 

 

DRUG INTERACTIONS

Clopidogrel
  • section added....

 

also see:

 

CLINICAL PHARMACOLOGY

Pharmacokinetics
  • Clopidogrel.....

 

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