Sulfasalazine

CONTRAINDICATIONS Sulfasalazine delayed release tablets are contraindicated in: Hypersensitivity to sulfasalazine, its metabolites, sulfonamides or salicylates, Patients with intestinal or urinary obstruction, Patients with porphyria, as the sulfonamides have been reported to precipitate an acute attack. WARNINGS Hepatic, Renal, and Hematologic Toxicity or Other Conditions Only after critical appraisal should sulfasalazine delayed release 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 sulfasalazine delayed release tablets (see PRECAUTIONS, Laboratory Tests ). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Discontinue sulfasalazine delayed release tablets if renal function deteriorates while on therapy.