GENERIC NAME: sulfasalazine

BRAND NAME: Azulfidine

DRUG CLASS AND MECHANISM: Sulfasalazine is a prodrug, that is, it is not active in its ingested form. It is broken down by bacteria in the colon into two products: 5-aminosalicylic acid (5ASA), and sulfapyridine. There is some controversy as to which of these two products are responsible for the activity of azulfidine. Whereas it is known that 5ASA has therapeutic benefit, it is not clear whether sulfapyridine adds any further benefit. In the colon, the products created by the breakdown of sulfasalazine work as anti-inflammatory agents for treating inflammation of the colon. The beneficial effect of sulfasalazine is believed to be due to a local effect on the bowel, although there may also be a beneficial systemic immune-suppressant effect as well. Following oral administration, 33% of the sulfasalazine is absorbed, all of the sulfapyridine is absorbed, and about 33% of the 5ASA is absorbed. Sulfasalazine was approved by the FDA in 1950.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: Uncoated and enteric coated tablets, each containing 500mg.

STORAGE: The tablets should be kept at room temperature, 15-30°C (59-86°F).

PRESCRIBED FOR: Sulfasalazine is used for the treatment of mild to moderate ulcerative colitis; as adjunctive therapy (i.e. with other medications) in the treatment of severe ulcerative colitis; for the treatment of Crohn's disease; for the treatment of rheumatoid arthritis or ankylosing spondylitis.

DOSING: Doses range from 500mg to 2000mg, and dosing intervals range from every 6 hours to every 12 hours, depending on the clinical condition of the patient. Higher doses have also been used. Sulfasalazine should be taken with a full glass of water after meals or with food to minimize stomach upset. Patients with kidney diseases may need to use lower doses of sulfasalazine.

DRUG INTERACTIONS: Sulfasalazine may cause reduced absorption of folic acid and of digoxin.

PREGNANCY: In hundreds of pregnant women with ulcerative colitis or Crohn's disease treated with sulfasalazine, there has been no increase in the risk of fetal malformations relative to other women with these illnesses who have not been treated with sulfasalazine. Additionally, there have not been ill effects on pregnant animals given high doses of sulfasalazine. Thus, sulfasalazine may be used during pregnancy if the physician feels the benefit outweighs the possible risk.

It should also be noted, however, that sulfasalazine may reduce sperm count and sperm function in men taking the medication. These effects are reversible upon stopping the medication.

NURSING MOTHERS: Caution should be exercised by women who are nursing their infants. Sulfasalazine and its constituents penetrate into breast milk and may displace bilirubin in the newborn. This can cause jaundice.

SIDE EFFECTS: Gastrointestinal disturbances frequently occur in patients taking sulfasalazine. Nausea, vomiting, gastric distress, and anorexia (loss of appetite) occur in about 1 of every 3 patients receiving the drug. Dizziness can occur during sulfasalazine therapy but does not require medical attention unless it is persistent. Sulfasalazine frequently causes the skin or the urine to change color. Development of an orange-yellow coloration is of no cause for concern.

Several potentially dangerous side effects have been rarely reported with sulfasalazine. A drop in white blood cell count or a type of anemia in which red blood cells are disrupted (hemolyzed) occur more frequently in patients with arthritis who are treated with sulfasalazine (about 6 per 1,000) than in patients with ulcerative colitis or Crohn's disease who are treated with sulfasalazine (about 6 per 10,000). These effects are characterized by fever, pale skin, sore throat, fatigue, and unusual bleeding and bruising, and require discontinuation of the drug.

Continuing headache, allergic reactions, and photosensitivity may develop during sulfasalazine therapy and require medical attention. Some of the allergic reactions may progress from a rash to difficulty in swallowing, blistering, peeling, or loosening of the skin, aching joints and muscles, and unusual tiredness or weakness. It may be accompanied by fever. The more severe allergic reactions are rare.

Last Editorial Review: 12/31/1997

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