Sulfasalazine Dosage

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Usual Adult Dose for Crohn's Disease - Acute

Initial dose: 500 mg orally 2 to 4 times a day, with food

Maintenance dose: 3 to 4 g per day orally in divided doses; some patients may require up to 6 g per day, especially if fast acetylators

Usual Adult Dose for Ulcerative Colitis - Active

Initial dose: 500 mg orally 2 to 4 times a day, with food

Maintenance dose: 3 to 4 g per day orally in divided doses; some patients may require up to 6 g per day, especially if fast acetylators

Usual Adult Dose for Ulcerative Colitis - Maintenance

500 mg orally 4 times a day, with food

Usual Adult Dose for Crohn's Disease - Maintenance

500 mg orally 2 to 4 times a day, with food

Usual Adult Dose for Rheumatoid Arthritis

Delayed release tablet:
Initial dose:
Week 1: 500 mg orally once a day
Week 2: 500 mg orally twice a day
Week 3: 500 mg orally in the morning and 1000 mg in the evening

Maintenance dose: 1000 mg orally twice a day; may consider increasing to 3000 mg per day if the clinical response is inadequate after 12 weeks

Results of the Combinatietherapie Bij Reumatoide Artritis (COBRA) trial in early rheumatoid arthritis where sulfasalazine (SSZ) alone was compared with the combination of prednisolone, methotrexate and SSZ, reported that at 6 months the combination therapy retarded radiographic progression much better than SSZ alone (p less than 0.0001).

Usual Adult Dose for Uveitis

Study (n=10) - Acute anterior recurrent uveitis
Initial dose: 500 mg per day, then increased by 500 mg per week

Maintenance dose: 1 g twice a day for one year; in cases of new flare, dose was increased by 500 mg per week up to 3 g per day

Usual Pediatric Dose for Ulcerative Colitis

6 years or older:
Initial dose: 40 to 60 mg/kg/day orally divided into 3 to 6 doses
Maintenance dose: 30 mg/kg/day orally divided into 4 doses

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Polyarticular-course:
Delayed release tablet:
6 years or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses (increase weekly by 10 mg/kg/day)
Usual dose: 30 to 50 mg/kg/day orally divided in 2 doses
Maximum dose: 2 g per day

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Sulfasalazine is contraindicated in patients with intestinal or urinary obstruction and patients with porphyria.

Only after critical assessment should sulfasalazine be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the use 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. Patients should seek medical advice if clinical signs such as sore throat, fever, pallor, purpura, or jaundice occur as they may indicate serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done often in patients receiving sulfasalazine. Sulfasalazine treatment should be discontinued while waiting for blood test results.

Complete blood counts, including differential white cell count and liver function tests, should be performed prior to starting sulfasalazine and every second week during the first 3 months of therapy. During the second 3 months, the same tests should be done once monthly and thereafter once every 3 months, as clinically necessary. Urinalysis and an assessment of renal function should be done periodically during sulfasalazine therapy. Determination of serum sulfapyridine levels may be useful since concentrations greater than 50 mcg/mL appear to be associated with an increased incidence of adverse events.

Oligospermia and infertility have been reported in men treated with sulfasalazine; however, discontinuation of the drug appears to reverse these effects.

Sulfasalazine should be administered with caution to patients with severe allergy or bronchial asthma. Patients should be advised to discontinue therapy and contact their physician should they develop a rash, especially if rash is accompanied by lymphadenopathy, malaise, or fever. Sulfasalazine should be discontinued at once if toxic or hypersensitivity reactions occur.

Patients with glucose-6-phosphate dehydrogenase should be monitored closely for signs of hemolytic anemia which is often dose related.

Sulfasalazine delayed release tablets have passed undisintegrated in isolated cases. If this occurs, the product should be discontinued at once.

Safety and effectiveness have not been established for ulcerative colitis in pediatric patients less than 2 years of age.

Dialysis

Data not available

Other Comments

Patients should be advised to maintain adequate fluid intake in order to prevent crystalluria and stone formation and that sulfasalazine may produce an orange-yellow discoloration of urine or skin.

Delayed release tablets should be swallowed whole.

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