Sulazine tablets


  • Active Ingredient: Sulfasalazine
  • 500 mg
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What is Sulazine?

The active ingredient of Sulazine brand is sulfasalazine. Sulfasalazine affects a substance in the body that causes inflammation, tissue damage, and diarrhea. Molecular Formula: C18H14N4O5S In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%. Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue Sulfasalazine if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Sulfasalazine. For a patient who develops a new infection during treatment with Sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Caution should be exercised when considering the use of Sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections. Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of Sulfasalazine. Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment. Sulfasalazine 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 have been reported in patients taking Sulfasalazine. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Sulfasalazine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Used for

Sulazine is used to treat diseases such as: Alopecia, Crohn's Disease, Crohn's Disease, Acute, Crohn's Disease, Maintenance, Inflammatory Bowel Disease, Juvenile Rheumatoid Arthritis, Lymphocytic Colitis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Ulcerative Colitis, Active, Ulcerative Colitis, Maintenance, Uveitis.

Side Effect

Possible side effects of Sulazine include: bloody diarrhea; pinpoint red spots on the skin; nausea; loss of appetite; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; chills.

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Generic Name: Sulazine (SUL fa SAL a zeen)Brand Name: Azulfidine, Azulfidine EN-tabs, Sulfazine

Medically reviewed by on Nov 9, 2018 – Written by Cerner Multum

Heart drug

When you take digoxin while taking Sulazine, your body absorbs less digoxin. Your doctor will monitor the amount of digoxin you get and may increase your dosage.

Disease Modifying Antirheumatic Drugs (DMARDs)

Sulazine (40 to 50 mg/kg/day, upper limit 2000 to 3000 mg) is effective for the management of peripheral disease activity that is the predominant presenting manifestation in both ERA and JAS patients. Two pediatric randomized placebo-controlled studies have been reported. In one study in JSpA patients, there was a statistically significant improvement in the patient and physician global assessment of disease activity in the Sulazine treatment group compared with placebo. 181 In a second study, Sulazine in comparison to placebo was found to be efficacious and safe, and the effects were sustained over many years. 182 Several open-labeled studies in children have shown good response, tolerability, and in some cases, achievement of disease remission with Sulazine. 183-188 Use of Sulazine in children has largely been based on experience in the adult AS, which has shown that although it is ineffective for axial disease, it has been helpful for the management of peripheral disease. 189-194 Beneficial effects of Sulazine are usually not evident for several weeks after initiation of treatment. Toxicity to bone marrow and liver must be monitored closely.

No controlled studies of methotrexate therapy in ERA or JAS have been reported, but based on efficacy and safety data from controlled studies in JIA, 195-197 methotrexate is used to treat peripheral arthritis of ERA. In a study of adults with AS who had not responded to NSAIDs and Sulazine, modest benefit was demonstrated with the use of methotrexate in a dose of 7.5 to 15 mg/week. 198,199 As the majority of patients with ERA are adolescents, strict counseling that includes avoiding alcohol consumption and pregnancy is mandatory to minimize the risks of methotrexate.

There are no reports of hydroxychloroquine or leflunomide in ERA or JAS. However, based on its efficacy in treatment of polyar­ticular JIA, 200,201 leflunomide could be considered for treatment of peripheral arthritis in ERA in children intolerant of Sulazine or methotrexate.

It is still unclear whether DMARDs have any effect on axial disease in ERA or JAS. However, based on evidence in adults with AS, biological therapies would be indicated in these patients.

Clinical monitoring

Your doctor may do the following tests regularly during your treatment with this drug:

  • Blood tests. Sulazine can decrease some of your blood cell counts, putting you at risk of infection. For the first three months of your treatment with this drug, your doctor will check your blood cell counts frequently. After that, your doctor will check them less often.
  • Liver tests. Sulazine can damage your liver.
  • Kidney tests. Sulazine is cleared from your body through your kidneys. If your kidneys aren’t working well, they won’t be able to get rid of the drug. This will increase your risk of side effects.

Which drugs or supplements interact with Azulfidine?

Sulazine may cause reduced absorption of folic acid and digoxin (Lanoxin). Reduced folic acid absorption may cause folic acid deficiency and result in anemia. Reduced digoxin absorption may reduce the effectiveness of digoxin. Sulfapyridine (a byproduct of Sulazine) is a sulfonamide, and sulfonamides increase blood levels of methotrexate (Rheumatrex, Trexall), resulting in increased methotrexate toxicity. Conversely, methotrexate can increase the occurrence of the anemia caused by sulfonamides because methotrexate also causes folic acid deficiency. Sulfonamides can increase the risk of kidney damage from cyclosporine by an unknown mechanism. They also may increase the blood glucose lowering effect of oral anti-diabetic drugs and potentially cause excessive reductions in blood sugar (hypoglycemia) by decreasing elimination of anti-diabetic drugs by the liver and elevating the levels of the anti-diabetic drugs in the blood.

Combining 5-ASA with drugs that affect kidney function such as nonsteroidal antiinflammatory drugs, for example, ibuprofen (Advil) may increase the likelihood of kidney dysfunction. Concurrent use of 5-ASA and 6-mercaptopurine or azathioprine (Imuran) may increase the likelihood of blood disorders. 5-ASA may increase the blood thinning effect of warfarin (Coumadin).


Sulazine tablets are contraindicated in:

Patients with intestinal or urinary obstruction, Patients with porphyria as sulfonamides have been reported to precipitate an acute attack, Patients hypersensitive to Sulazine, its metabolites, sulfonamides, or salicylates.

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