The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models.

AZULFIDINE EN-tabs Tablets are indicated: in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; for the prolongation of the remission period between acute attacks of ulcerative colitis; 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); and in the treatment of pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti- inflammatory drugs. (See Full Prescribing Information.)

Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. Children, six years of age and older: 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.

The most common adverse reactions associated with sulfasalazine in ulcerative colitis are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia.

AZULFIDINE EN-tabs 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.

AZULFIDINE EN-tabs Tablets should be given with caution to patients with severe allergy or bronchial asthma.