From the Guidelines
Sulfasalazine is primarily used to treat inflammatory bowel diseases like ulcerative colitis and Crohn's disease, as well as rheumatoid arthritis and other inflammatory conditions, but its use is limited due to its poor tolerability and potential for adverse effects 1.
Key Points
- The typical starting dose of sulfasalazine is 500 mg daily, gradually increasing to 2-3 grams daily divided into multiple doses for adults with inflammatory bowel disease, or 2-3 grams daily for rheumatoid arthritis.
- Sulfasalazine works by combining sulfapyridine (an antibiotic) with 5-aminosalicylic acid (an anti-inflammatory), with the latter being released in the colon where it reduces inflammation.
- Common side effects include nausea, headache, and stomach upset, which can be minimized by taking the medication with food and starting at a lower dose.
- More serious but rare side effects include blood disorders, liver problems, and allergic reactions, and patients should have regular blood tests to monitor for these effects.
- Sulfasalazine can cause reversible decreased sperm count in men and may turn urine or skin a harmless orange-yellow color.
- It should be used cautiously in patients with sulfa allergies, G6PD deficiency, or kidney/liver disease.
Evidence
Studies have shown that sulfasalazine is effective for induction and maintenance of remission in ulcerative colitis, but it is not as well tolerated as other medications such as mesalamine and diazo-bonded 5-ASA 1.
Recommendations
Sulfasalazine may be considered as an alternative treatment option for patients with mild-to-moderate ulcerative colitis who cannot tolerate other medications or have concomitant arthritic symptoms 1. However, due to its potential for adverse effects and poor tolerability, sulfasalazine should be used with caution and under close monitoring.
Important Considerations
- Patients should be informed about the potential risks and benefits of sulfasalazine and closely monitored for adverse effects.
- Regular blood tests should be performed to monitor for blood disorders, liver problems, and other potential adverse effects.
- Sulfasalazine should be used cautiously in patients with sulfa allergies, G6PD deficiency, or kidney/liver disease.
From the FDA Drug Label
INDICATIONS AND USAGE Sulfasalazine tablets, USP are indicated: in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and for the prolongation of the remission period between acute attacks of ulcerative colitis.
The use of sulfasalazine (Azulfidine) is for:
- Treatment of mild to moderate ulcerative colitis
- Adjunctive therapy in severe ulcerative colitis
- Prolongation of the remission period between acute attacks of ulcerative colitis 2
From the Research
Use of Sulfasalazine (Azulfidine)
- Sulfasalazine is used in the treatment of rheumatoid arthritis (RA) and other chronic inflammatory rheumatic diseases 3, 4, 5, 6, 7
- It is a disease-modifying antirheumatic drug (DMARD) that has been shown to be effective in inducing clinical improvement or remission in patients with RA 3, 4, 6
- The drug is typically used at a dose of 2-3 g/day, although the optimal dose and serum levels for efficacy are still being studied 3, 5, 7
- Sulfasalazine has been compared to other DMARDs, such as methotrexate, and has been found to be similarly effective, but with a more rapid onset of action 4, 6
- Combination therapy with other DMARDs, such as methotrexate, has been shown to be more effective than single DMARD therapy 4, 6
Efficacy and Safety
- Sulfasalazine has been shown to be effective in reducing disease activity and improving symptoms in patients with RA 4, 6
- The most common adverse effects of sulfasalazine are gastrointestinal, headache, dizziness, and rash, although myelosuppression can also occur 4, 6, 7
- The safety profile of sulfasalazine is generally considered to be favorable, with most adverse effects being reversible after treatment withdrawal 7