SALAZOPYRIN

What it is

SALAZOPYRIN and SALAZOPYRIN EN-TABS are formulations of sulfasalazine. SALAZOPYRIN tablets contain 500 mg of sulfasalazine, while SALAZOPYRIN EN-TABS enteric coated tablets contain 500 mg of sulfasalazine.

Approved indications

— Adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. — Treatment of active Crohn's disease, especially in patients with colonic involvement. — Rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (NSAIDs).

Dosing overview

SALAZOPYRIN or SALAZOPYRIN EN-TABS should be given preferably after meals in evenly divided doses over a 24 hour period with no more than 8 hours between overnight doses. Enteric coated tablets should not be crushed or broken.

Key safety warnings

Serious infections associated with myelosuppression, including sepsis and pneumonia, have been reported. Patients who develop a new infection while undergoing treatment with sulfasalazine should be monitored closely, and administration should be discontinued if a patient develops a serious infection. Deaths associated with the administration of sulfasalazine have been reported, resulting from hypersensitivity reactions, agranulocytosis, aplastic anaemia, renal and liver damage, irreversible neuromuscular and CNS changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice may be indications of myelosuppression, hepatotoxicity, haemolysis or other serious blood disorders. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of sulfasalazine. Patients appear to be at highest risk for these events early in the course of therapy, with onset occurring in the majority of cases within the first month of treatment. SALAZOPYRIN should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) have been reported. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and sulfasalazine should be discontinued if an alternative etiology cannot be established. Oral sulfasalazine inhibits the absorption and metabolism of folic acid and may cause folic acid deficiency, potentially resulting in serious blood disorders and the possibility of harming the foetus during pregnancy.

Contraindications

— Haematological, renal or hepatic dysfunction, allergic drug fever or skin eruptions due to sulphonamide derivatives including antibacterial sulphonamides, oral hypoglycaemics and thiazides. — Hypersensitivity to sulfasalazine, its metabolites, or any other component of the product, sulfonamides, or salicylates. — Intestinal or urinary obstruction. — Patients with porphyria should not receive sulphonamides, as these drugs have been reported to precipitate an acute attack. — Children aged 2 years and younger.

PBS listing

SALAZOPYRIN 500 mg tablet is listed on the PBS as a restricted item with an ex-manufacturer price of A$18.30.

Regulatory history

SALAZOPYRIN was first approved on 05 September 1991, with both the standard tablet formulation (ARTG 14486) and the enteric coated tablet formulation EN-TABS (ARTG 14485) registered on this date.