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.
