Label Changes for:

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating 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

  • ‚ĶHypersensitivity 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 
  

May 2012

5 WARNINGS AND PRECAUTIONS

5.4 Concomitant Use of PREVACID with Methotrexate
  • Literature suggests that concomitant use of PPIs with methotrexate .....

7 DRUG INTERACTIONS

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

 

October 2011

DRUG INTERACTIONS

Clopidogrel
  • Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically important effect....

also see:

CLINICAL PHARMACOLOGY

Pharmacokinetics
  • Clopidogrel...

 

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