PYRALIN

What it is

PYRALIN is an enteric coated tablet containing 500 mg of sulfasalazine.

Approved indications

— Adjunct in the treatment of ulcerative colitis with 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

For rheumatoid arthritis, the usual dose is 2 to 3 g daily in divided doses. For adults starting therapy, the daily dose should be raised gradually over four weeks, from 1 tablet in the evening in the first week to 2 tablets morning and evening by the fourth week, to a maximum of 3 g per day. For inflammatory bowel disease, PYRALIN should be given preferably after meals in evenly divided doses over a 24 hour period with no more than 8 hours between overnight doses. Initial dosing for inflammatory bowel disease is 1 to 2 g four times daily in adults, or 40 to 60 mg/kg bodyweight daily in children in three to six divided doses. Maintenance dosing is 2 g daily in four divided doses in adults, or 40 mg/kg bodyweight daily in four divided doses in children.

Key safety warnings

Deaths have been reported with sulfasalazine, resulting from hypersensitivity reactions, agranulocytosis, aplastic anaemia, renal and liver damage, irreversible neuromuscular and CNS changes, and fibrosing alveolitis. Clinical signs such as sore throat, fever, pallor, purpura or jaundice may indicate myelosuppression, hepatotoxicity, haemolysis or other serious blood disorders, and patients should be advised to report any untoward symptoms immediately. Serious infections associated with myelosuppression, including sepsis and pneumonia, have been reported. Patients who develop a new infection while undergoing treatment should be monitored closely, and sulfasalazine should be discontinued if a serious infection develops. Serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely. Patients are at highest risk early in therapy, with onset in the majority of cases within the first month. PYRALIN 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 without rash. If such signs or symptoms are present, the patient should be evaluated immediately and PYRALIN should be discontinued if an alternative cause cannot be established. 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. Complete blood counts including differential white cell count and liver function tests should be performed before starting treatment and every second week during the first three months. During the second three months, these tests should be done monthly and thereafter every three months, and as clinically indicated. Assessment of renal function including urinalysis should be performed initially and at least monthly for the first three months of treatment, and thereafter as clinically indicated.

Contraindications

PYRALIN is contraindicated in patients with haematological, renal or hepatic dysfunction, or allergic drug fever or skin eruptions due to sulphonamide derivatives. It is also contraindicated in patients hypersensitive to sulfasalazine, its metabolites, or any other component of the product, sulfonamides, or salicylates. Intestinal or urinary obstruction is a contraindication. Patients with porphyria should not receive PYRALIN, as sulphonamides have been reported to precipitate an acute attack. PYRALIN is contraindicated in children aged 2 years and younger.

PBS listing

PYRALIN 500 mg enteric coated tablet is listed on the PBS with a restriction, at an ex-manufacturer price of A$20.15.

Regulatory history

PYRALIN was first approved on 05 September 1991. The enteric coated 500 mg tablet formulation was first listed on the ARTG on 27 February 1997.