Label Changes for:

Cortenema (hydrocortisone retention enema)

February 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) -- February 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

PRECAUTIONS

  • General
    • Cortenema hydrocortisone retention enema should be used with caution...
  • Information for Patients
    • Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles...

WARNINGS

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If expsosed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated...

...If chicken pox develops, treatment with antiviral agents may be considered.

Contact ANI Pharmaceuticals at 1-800-434-1121 for Prescribing Information.

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