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Sulfasalazine

    Brands

    DEA Class; Rx

    Common Brand Names; Azulfidine, Azulfidine EN

    • 5-Aminosalicylic Acid Derivatives; 
    • DMARDs, Other

    Oral prodrug; metabolized by intestinal bacteria to sulfapyridine and 5-aminosalicylate (5-ASA, also known as mesalamine)
    Used to treat ulcerative colitis, rheumatoid arthritis, and juvenille idiopathic arthritis (JIA)
    The sulfapyridine component is particularly associated with adverse reactions vs. 5-ASA use alone

    Indicated for the treatment of mild to moderate ulcerative colitis and as an adjunct for severe ulcerative colitis.

    For the treatment of rheumatoid arthritis in patients who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.
    For the treatment of juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA) that has responded poorly to salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs).
    For the treatment of mild to moderately active Crohn’s disease with colonic involvement.

    Hypersensitivity to sulfasalazine or its metabolites, to sulfonamides, or to salicylates

    Intestinal or urinary tract obstruction

    Porphyria

    • Anorexia (~33%)
    • Headache (~33%)
    • Nausea (~33%)
    • Vomiting (~33%)
    • Gastric distress (~33%)
    • Apparently reversible oligospermia (~33%)
    • Skin rash
    • Pruritus
    • Urticaria
    • Fever
    • Heinz body anemia
    • Hemolytic anemia
    • Cyanosis

    Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, and toxic epidermal necrolysis; discontinue at first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity

    Severe hypersensitivity reported; may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (ie, pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration; if signs or symptoms are present, the patient should be evaluated immediately; Sulfasalazine drug should be discontinued if an alternative etiology for signs or symptoms cannot be established

    Administer tablets with caution to patients with severe allergy or bronchial asthma; adequate fluid intake must be maintained in order to prevent crystalluria and stone formation; patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia; reaction is frequently dose-related; if toxic or hypersensitivity reactions occur, the drug should be discontinued immediately

    Oligospermia and infertility reported; however, withdrawal of drug appears to reverse these effects

    Pregnancy category: B; D if used for prolonged periods or near term; increased potential for kernicterus in the newborn

    Oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and protection from neural tube defects

    Lactation: Excreted into human breast milk; caution with breastfeeding, some reports of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine

    Adults

    4 grams/day PO for ulcerative colitis; 3 grams/day PO for rheumatoid arthritis.

    Geriatric

    4 grams/day PO for ulcerative colitis; 3 grams/day PO for rheumatoid arthritis.

    Adolescents

    60 mg/kg/day PO (not to exceed 4 grams/day) PO for ulcerative colitis induction; 30 mg/kg/day PO for ulcerative colitis maintenance. 2 grams/day PO for juvenile rheumatoid arthritis (JRA).

    Children

    6 years and older: 60 mg/kg/day PO (not to exceed 4 grams/day) PO for ulcerative colitis induction; 30 mg/kg/day PO for ulcerative colitis maintenance. 2 grams/day PO for juvenile rheumatoid arthritis (JRA).
    2 to 5 years: 40 to 60 mg/kg/day PO (not to exceed 4 grams/day) PO has been used for ulcerative colitis.
    Less than 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Sulfasalazine

    tablet

    • 500mg

    tablet, enteric coated (delayed release)

    • 500mg