Azulfidine® En-Tabs

WARNINGS Only after critical appraisal should AZULFIDINE EN-tabs Tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving AZULFIDINE EN-tabs (see PRECAUTIONS, Laboratory Tests). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Discontinue AZULFIDINE EN-tabs immediately if serious hematologic, hepatic, or other serious adverse reactions occur. Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue AZULFIDINE EN-tabs if a patient develops a serious infection. Closely monitor patients during and after treatment with AZULFIDINE EN-tabs for the development of signs and symptoms of infection. Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration. Severe cutaneous adverse reactions (SCARs), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) have been reported in association with sulfasalazine use. SCARs can be life-threatening or fatal. Patients should be advised of the signs and symptoms of serious skin reactions and closely monitored during treatment. Highest risk for occurrence of TEN or SJS is within the first weeks of treatment. If signs and symptoms suggestive of DRESS, TEN, or SJS (e.g., progressive skin rash often with blisters or mucosal lesions) are present, sulfasalazine treatment should be discontinued immediately.