Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- PROTONIX is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions (5.2)] or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
- Acute interstitial nephritis has been observed in patients taking PPIs including PROTONIX I.V. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue PROTONIX I.V. if acute interstitial nephritis develops [see Contraindications (4)].
- agranulocytosis, pancytopenia and taste disorders (ageusia, dyseusia)
5 WARNINGS AND PRECAUTIONS
5.9 Concomitant use of Protonix with Methotrexate
- Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong...
- Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant.....
- weight changes
- fatigue and malaise
- insomnia and somnolence
- information about the drug-drug interaction between pantoprazole and clopidogrel