Pharm

Sulfasalazine

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Sulfasalazine, Azulfidine, Olsalazine, Dipentum

  • Mechanism
  1. 5-Aminosalicylic Acid Derivative which is metabolized into sulfapyridine and Mesalamine
  • Indications
  1. Inflammatory Bowel Disease (e.g. Ulcerative Colitis)
  2. Early Rheumatoid Arthritis (especially seronegative)
  3. Psoriatic Arthritis
  4. Arthritis in Reiter's Syndrome
  1. Consider Mesalamine (Asacol, Pentasa) as alternative
  2. Consider slowly tapering to dose if unclear allergy
    1. Start: 250 grams per day
    2. Increase: 250 grams per week
  • Dosing
  • Sulfasalazine
  1. Ulcerative Colitis dosing target
    1. Active disease: Sulfasalazine 4-6 grams/day divided four times daily
    2. Maintenanance: Sulfasalazine 2-4 grams/day divided four times daily
  2. General
    1. Increase slowly to lowest effective dose
    2. Co-administer Folic Acid 1 mg/day
  3. Increase Protocol
    1. Start: 500 mg per day
    2. Increase: 500 mg per week up to 2 grams per day
    3. Increase: 3 grams per day after 3 months
    4. Maximum: 4 grams per day (2 grams twice daily) after 6 months
  4. Maintenance Doses
    1. Adult: 500-1000 mg PO qid with food
    2. Pediatric: 20-60 mg/kg/day divided qid with food
  • Dosing
  • Olsalazine (Dipentum)
  1. Olsalazine (Dipentum) 500 mg orally twice daily (as of 2022, >$1500/month)
  • Adverse effects
  1. General
    1. Prevent adverse effects with Folic Acid 1-2 mg/day
  2. Nausea and other Gastrointestinal Intolerance (30%)
    1. Consider enteric coated Azulfidine EN-tablets
  3. Neurologic adverse effects
    1. Headache (20%)
    2. Dizziness or lightheaded (<20%)
  4. Hematologic adverse effects
    1. Folate-inhibition Anemia
    2. Hemolytic Anemia
    3. Granulocytopenia
  5. Skin rash associated with Sulfa Allergy
    1. Requires discontinuing medication immediately
  6. Renal adverse effects: Micro-Crystalluria
    1. Risk of Interstitial Nephritis
    2. Avoid Dehydration
    3. Avoid high doses
  • Monitoring
  1. Complete Blood Count (CBC) every 4-6 months
  2. Aspartate Aminotransferase (AST, SGOT) at 2 months
  • References
  1. Adams (2013) Am Fam Physician 87(10): 699-705 [PubMed]
  2. Adams (2022) Am Fam Physician 105(4): 406-11 [PubMed]
  3. Kornbluth (2010) Am J Gastroenterol 105(3): 501-23 [PubMed]
  4. Matteson (2000) Mayo Clin Proc 75:669-74 [PubMed]
  5. Pincus (1999) Clin Rheumatol 17(6 Suppl 18):S2-S124 [PubMed]