Uses
Ulcerative Colitis
Adjunct for management of mild to moderate ulcerative colitis.
Crohn’s Disease
Management of active Crohn’s disease†.
May be useful in patients with mild to moderately active disease, especially those with ileocolonic or colonic involvement. May not be effective in patients with small bowel disease. Many clinicians recommend that the drug be used in patients with left-sided disease, restricted to the colon.
Patients who have previously received corticosteroid therapy or have undergone surgical resection may fail to respond to sulfasalazine therapy. Those who have not received corticosteroids or have not undergone surgery may respond substantially better to sulfasalazine than to placebo.
There is some evidence that concomitant therapy with sulfasalazine and corticosteroids may not be more effective than either drug alone, but some subgroups of patients may have a better response to combined therapy (e.g., those with disease localized in the colon).
Does not appear to be useful for maintenance therapy once a remission has been attained or following surgical resection.
Rheumatoid Arthritis in Adults
Management of rheumatoid arthritis in adults whose symptoms progress despite an adequate regimen of NSAIAs. One of several disease-modifying antirheumatic drugs (DMARDs) that can be used when DMARD therapy is appropriate.
Usually used in conjunction with analgesic and/or NSAIA therapy, at least until the beneficial effects of sulfasalazine are apparent. Administration of sulfasalazine alone is not a complete treatment for rheumatoid arthritis.
Has been used in conjunction with other DMARDs (e.g., azathioprine, gold compounds, hydroxychloroquine, methotrexate, penicillamine) and/or systemic corticosteroids.
Juvenile Arthritis
Management of the signs and symptoms of polyarticular course juvenile rheumatoid arthritis in children who have not responded adequately to NSAIAs. Not recommended for management of systemic course juvenile rheumatoid arthritis because of the high frequency of adverse effects reported in children.
Dosage and Administration
Administration
Oral Administration
Administer orally, preferably after meals.
Delayed-release tablets should be swallowed whole.
Maintain adequate fluid intake to prevent crystalluria and stone formation.
Dosage
Pediatric Patients
Ulcerative Colitis
Oral
Conventional tablets in children ≥ 2 years of age: initial dosage is 40–60 mg/kg daily in 3–6 divided doses and usual maintenance dosage is 30 mg/kg daily in 4 divided doses. Interval between doses should not exceed 8 hours.
Delayed-release tablets in children ≥6 years of age: initial dosage is 40–60 mg/kg daily in 3–6 divided doses and usual maintenance dosage is 30 mg/kg daily in 4 divided doses. Interval between doses should not exceed 8 hours.
Crohn's Disease
Oral
Initiate therapy with 25–40 mg/kg daily and increase to 50–75 mg/kg daily (maximum daily dosage 4 g).†
Juvenile Arthritis
Polyarticular Course
Oral
Delayed-release tablets in children ≥6 years of age: 30–50 mg/kg daily in 2 equally divided doses; the maximum dosage usually is 2 g daily.
To reduce GI intolerance, the manufacturers recommend that therapy be initiated with ¼ to (1/3) of the planned maintenance dosage, and that dosage be increased at weekly intervals until the planned maintenance dosage is achieved (usually at week 4).
Adults
Ulcerative Colitis
Oral
Conventional or delayed-release tablets: initial dosage is 3–4 g daily given in equally divided doses; interval between doses should not exceed 8 hours. In some patients, it may be advantageous to initiate therapy with a dosage of 1–2 g daily to lessen adverse GI effects. Usual maintenance dosage is 2 g daily in 4 divided doses, although some clinicians advocate a lower maintenance dosage of 1–1.5 g daily if necessary to prevent adverse effects.
Dosage as high as 12 g daily has been used for initial therapy, but dosage >4 g daily is accompanied by increased incidence of adverse effects. Generally avoid dosage >4 g daily unless serum concentrations of total sulfapyridine and the phenotype of the patient are known.
Efficacy of maintenance therapy appears to be dose related, but potential benefits of dosages >2 g daily must be weighed against the risks of increased adverse effects and the necessity for more careful patient monitoring.
Crohn's Disease
Oral
Mildly to moderately active disease: 3–6 g daily (as conventional or delayed-release tablets) has been used.†
Maintenance: 1.5–3 g daily (as conventional or delayed-release tablets) has been used, although such dosages do not appear to be more effective than placebo when used in patients with medically induced remission.†
Rheumatoid Arthritis
Oral
Delayed-release tablets: 2–3 g daily given in equally divided doses every 12 hours.
It may be advantageous to initiate therapy with a dosage of 0.5–1 g daily to lessen adverse GI effects. The manufacturers recommend that patients receive 0.5 g every evening the first week of therapy, 0.5 g twice daily (morning and evening) the second week, 0.5 g every morning and 1 g every evening the third week, and 1 g twice daily (morning and evening) thereafter.
A response to sulfasalazine (manifested by improvement in the number and extent of actively inflamed joints) may not occur until after 4–12 weeks of therapy.
Patients receiving sulfasalazine dosages >2 g daily should be carefully monitored.
Prescribing Limits
Pediatric Patients
Juvenile Arthritis
Oral
Maximum of 2 g daily.
Crohn's Disease
Oral
Maximum of 4 g daily.†
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