Label Changes for:

Protonix (pantoprazole sodium) For Delayed Release Oral Suspension and Delayed Release Tablets

October 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011

 

 

ADVERSE REACTIONS

Postmarketing Experience:
  • weight changes, hyponatremia, asthenia, fatigue and malaise, insomnia and somnolence

 

DRUG INTERACTIONS

Clopidogrel
  • co-administration of clopidogrel with pantoprazole reduces the pharmacological activity of clopidogrel

 

also see:

 

  • Pharmacokinetics: information about the drug-drug interaction between pantoprazole and clopidogrel.
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