Label Changes for:

Noroxin (norfloxacin) Tablets

September 2008

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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

  • Hypersensitivity Reactions

PRECAUTIONS

  • General
    • Moderate to severe photosensitivity/phototoxicity reactions...
  • Information for Patients
    • Patients should be advised:
      • ...The risk of serious tendon disorders with quinolones is
        higher in those over 65 years of age and those on corticosteroids.
  • Geriatric Use
    • In general, elderly patients may be more susceptible to drug-associated effects of the QTc interval...
    • Patients over 65 years of age are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone antibiotic such as Noroxin...

ADVERSE REACTIONS

  • Postmarketing
    • Skin
      • ...photosensitivity/phototoxicity reactions (see PRECAUTIONS)
    • Hepatic
      • Hepatic failure, including fatal cases

PATIENT PACKAGE INSERT (new)

WARNINGS

Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Noroxin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

  • fever, rash or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson
    syndrome);
  • vasculitis; arthralgia; myalgia; serum sickness;
  • allergic pneumonitis;
  • interstitial nephritis; acute renal insufficiency or failure;
  • hepatitis; jaundice; acute hepatic necrosis or failure;
  • anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity, and supportive measures should be instituted (see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS).

Label approved 09/23/2008 is not available on this site

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