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.
