Pharm

Sulfasalazine

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Sulfasalazine, Azulfidine, Olsalazine, Dipentum

  • Mechanism
  1. 5-Aminosalicylic Acid Derivative which is metabolized into sulfapyridine and Mesalamine
  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