Label Changes for:

Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use

January 2008

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


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Clostridium difficile associated disease (CDAD)

PRECAUTIONS

  • Information for Patients
    • Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic
      is discontinued...

WARNINGS

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Azactam, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

The Jan 2008 Label not available at this site.

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