Sulfasalazine Delayed-Release Tablets, USP, 500 mg are indicated:a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c) in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); andd)in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.Sulfasalazine Delayed-Release Tablets, USP, 500 mg is particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued.
Unlike anti-inflammatory drugs, Sulfasalazine Delayed-Release Tablets, USP, 500 mg does not produce an immediate response.Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of Sulfasalazine Delayed-Release Tablets, USP, 500 mg is apparent.
Only after critical appraisal should Sulfasalazine Delayed-Release Tablets, USP, 500 mg 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.
Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving Sulfasalazine Delayed-Release Tablets, USP, 500 mg (see PRECAUTIONS, Laboratory Tests).Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects.