|Manufacturer:||Pharmacia and Upjohn Company|
|Other Info:||Rx onlyLAB-0241-2.0Revised August 2006|
AZULFIDINE Tablets are indicated:a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb)for the prolongation of the remission period between acute attacks of ulcerative colitis.
-- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.
AZULFIDINE Tablets are contraindicated in: Patients with intestinal or urinary obstruction, Patients with porphyria, Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.
-- group of disorders characterized by the excessive production of porphyrins or their precursors that arises from abnormalities in the regulation of the porphyrin-heme pathway; acquired porphyrias, which are due to inhibition of enzymes in the metabolic pathway by a drug, toxin or abnormal metabolite, are more common than those which are inherited.
Only after critical appraisal should AZULFIDINE 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.
Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving AZULFIDINE (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.
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