Label Changes for:
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
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)
- …Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
Cyanocobalamin (vitamin B12) Deficiency
*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
5 WARNINGS AND PRECAUTIONS
5.4 Concomitant Use of PREVACID with Methotrexate
- Literature suggests that concomitant use of PPIs with methotrexate .....
7 DRUG INTERACTIONS
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate .....
- Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically important effect....