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Safety

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EpiPen JR (epinephrine) Auto-Injector 0.15 mg September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

PRECAUTIONS

  • General
  • Information for Patients
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Usage in Pregnancy

ADVERSE REACTIONS

  • Adverse reactions to epinephrine include...

WARNINGS

See prescribing information for multiple labeling revisions, including information regarding:

  • ...Injection into the buttock may not provide effective treatment of anaphylaxis...
  • ...accidental injection into the digits, hands or feet, may result in loss of blood flow to the affected area...
  • ...The presence of a sulfite in this product should not defer administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.
  • ...epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias...
    
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