Label Changes for:

Azulfidine (sulfasalazine) and Azulfidine EN  (sulfasalazine delayed release) tablets

October 2009

Changes have been made to the CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

CONTRAINDICATIONS

  • Azulfidine Tablets are contraindicated in Patients with porphyria as sulfonamides have been reported to precipitate an acute attack

WARNINGS

  • The presence of clinical signs such as... hepatotoxicity
  • Discontinue treatment with sulfasalazine while awaiting the results of blood tests.

ADVERSE REACTIONS 

Hypersensitivity reactions

  • drug rash with eosinophilia and systemic symptoms (DRESS), interstitial lung disease
Gastrointestinal reactions
  • hepatic failure

OVERDOSAGE

  • Azulfidine (sulfasalazine) tablets:Doses of Azulfidine tablets of 16 g per day have been given to patients without mortality.
  • Azulfidine EN (sulfasalazine) delayed release tablets: Doses of regular sulfasalazine tablets of 16 g per day have been given to patients without mortality.
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