Sulfasalazine

Indications

INDICATIONS AND USAGE Sulfasalazine delayed release tablets 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); and d) in the treatment of pediatric patients with polyarticular-course 1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION The dosage of sulfasalazine delayed release tablets should be adjusted to each individual's response and tolerance. Patients should be instructed to take sulfasalazine delayed release tablets in evenly divided doses, preferably after meals, and to swallow the tablets whole. Ulcerative Colitis Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance.

Contraindications

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 and precautions

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.

Pregnancy

Pregnancy: There are no adequate and well-controlled studies of sulfasalazine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine.

Storage and supply

Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) .

Source: Sulfasalazine (Sulfasalazine) — US FDA prescribing information, 2026-08-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.