What is the use of Sulfasalazine (Salazopyrin)?

From the Guidelines

Sulfasalazine (Salazopyrin) is primarily used to treat inflammatory bowel diseases like ulcerative colitis and rheumatoid arthritis, but its use is limited due to poor tolerability and potential side effects, making it a less preferred option compared to mesalamine and diazo-bonded 5-ASA 1.

Key Points

• Sulfasalazine is effective for induction and maintenance of remission in ulcerative colitis, but its use is often limited by side effects such as headache, nausea, diarrhea, and rash 1.
• The typical starting dose is 500mg daily, gradually increasing to 2-3g daily divided into multiple doses to minimize side effects.
• Patients should take Sulfasalazine with food to reduce stomach upset and drink plenty of water to prevent kidney complications.
• Common side effects include nausea, headache, and skin rash, and patients should be aware that Sulfasalazine can cause orange-yellow discoloration of urine and skin, and may reduce sperm count temporarily in men.
• Regular blood tests are necessary to monitor for potential blood disorders or liver problems, and those with sulfa allergies should avoid this medication 1.

Evidence Summary

• A 2019 study published in Gastroenterology found that Sulfasalazine was more effective than placebo for induction of remission in ulcerative colitis, but its use was limited by poor tolerability and potential side effects 1.
• The same study found that mesalamine and diazo-bonded 5-ASA were more effective and better tolerated than Sulfasalazine for induction and maintenance of remission in ulcerative colitis.
• A technical review published in 2019 also found that Sulfasalazine was effective for induction and maintenance of remission in ulcerative colitis, but its use was limited by poor tolerability and potential side effects 1.

Clinical Considerations

• Patients with concomitant arthritic symptoms may benefit from the use of Sulfasalazine, but its use should be carefully considered due to potential side effects and poor tolerability.
• Regular monitoring of blood counts and liver function tests is necessary to minimize the risk of potential side effects.
• Patients should be informed of the potential side effects and benefits of Sulfasalazine, and alternative treatments should be considered if necessary.

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 (Salazopyrin) is for:

• Treatment of mild to moderate ulcerative colitis
• Adjunctive therapy in severe ulcerative colitis
• Prolongation of remission between acute attacks of ulcerative colitis 2

From the Research

Uses of Sulfasalazine (Salazopyrin)

• Sulfasalazine is used in the treatment of patients with rheumatoid arthritis, as a disease-modifying antirheumatic drug (DMARD) 3
• It is also effective in the treatment of ulcerative colitis, with a response rate of 75-80% in patients with this condition 4
• Sulfasalazine can be used to prevent relapses in ulcerative colitis, particularly if the dosage is increased 4
• It is used in combination with other DMARDs, such as methotrexate and hydroxychloroquine, in patients with early rheumatoid arthritis and in those with more established disease 3

Therapeutic Potential

• Sulfasalazine has therapeutic potential in chronic inflammatory bowel disease, particularly in ulcerative colitis 5, 6
• It is used as a first-line therapy for induction of remission in mild to moderate active ulcerative colitis, along with 5-aminosalicylic acid (5-ASA) 6
• Topical treatment with sulfasalazine suppository or 5-ASA enema is considered for the treatment of proctitis or distal type of ulcerative colitis 6

Comparison with Other Drugs

• Sulfasalazine has broadly similar efficacy to other DMARDs, such as methotrexate and hydroxychloroquine, in the treatment of rheumatoid arthritis 3
• Mesalazine, the active moiety of sulfasalazine, is available in specially formulated oral and rectal forms, and has therapeutic potential in Crohn's disease 5
• Mesalazine enemas have been shown to be effective in treating refractory cases of distal ulcerative colitis, proctitis, and proctosigmoiditis 7