II. Mechanism

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

IV. Contraindications: Sulfa Allergy

  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

V. 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

VI. Dosing: Olsalazine (Dipentum)

  1. Olsalazine (Dipentum) 500 mg orally twice daily (as of 2022, >$1500/month)

VII. 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

VIII. Monitoring

  1. Complete Blood Count (CBC) every 4-6 months
  2. Aspartate Aminotransferase (AST, SGOT) at 2 months

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Related Studies

Cost: Medications

sulfasalazine (on 5/17/2017 at Medicaid.Gov Survey of pharmacy drug pricing)
SULFASALAZINE 500 MG TABLET Generic $0.16 each
SULFASALAZINE DR 500 MG TAB Generic $0.24 each
azulfidine (on 6/1/2017 at Medicaid.Gov Survey of pharmacy drug pricing)
AZULFIDINE ENTAB 500 MG Generic $0.24 each
dipentum (on 10/19/2016 at Medicaid.Gov Survey of pharmacy drug pricing)
DIPENTUM 250 MG CAPSULE $12.25 each

Ontology: Sulfasalazine (C0036078)

Definition (NCI) A synthetic salicylic acid derivative with affinity for connective tissues containing elastin and formulated as a prodrug, antiinflammatory Sulfasalazine acts locally in the intestine through its active metabolites, sulfamide 5-aminosalicylic acid and salicylic acid, by a mechanism that is not clear. It appears inhibit cyclooxygenase and prostaglandin production and is used in the management of inflammatory bowel diseases. (NCI04)
Definition (MSH) A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907)
Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
MSH D012460
SnomedCT 387248006, 45844004, 363635007, 317422008, 330038003
LNC LP18088-2, MTHU006799, MTHU003000
English Salazosulfapyridine, Salicylazosulfapyridine, Sulfasalazine, Sulphasalazine, Benzoic acid, 2-hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)-, Sulfasalazine [gastro-intest], Sulfasalazine [musc-skel], Sulphasalazine [gastro-intest], Sulphasalazine [musc-skel], 2-Hydroxy-5-[[4-[(2-pyridinylamino)sulfonyl]phenyl]azo]benzoic Acid, salazosulfapyridine, Sulfasalazine [gastro-intestinal use], Sulphasalazine [gastro-intestinal use], Sulfasalazine [musculoskeletal use], Sulphasalazine [musculoskeletal use], sulfasalazine (medication), SULFASALAZINE, Sulfasalazine [Chemical/Ingredient], sulphasalazine, salicylazosulfapyridine, sulfaSALAzine, SulfaSALAzine, sulfasalazine, Sulphasalazine product, Sulfasalazine [musculoskeletal use] (product), Sulfasalazine product, Sulfasalazine [gastro-intestinal use] (product), Sulfasalazine product (substance), Salazosulphapyridine, Salicylazosulphapyridine, Sulfasalazine (product), Sulfasalazine (substance), Sulfasalazine [gastro-intestinal use] (substance), Sulfasalazine [musculoskeletal use] (substance)
Swedish Sulfasalazin
Czech sulfasalazin
Finnish Salatsosulfapyridiini
Japanese エミナピリン, スルファサラジン, ラノフェン, アザルフィジンEN, サリチルアゾサルファピリジン, サラゾピリン, スラマ錠, スラマ, サフィルジンEN, Slama錠, サラゾスルファピリジン
French Sulfasalazine, Salicylazosulfapyridine
Polish Salazosulfapirydyna, Sulfasalazyna
Spanish sulfasalazina [uso gastrointestinal] (producto), sulfasalazina [uso musculoesquelético], sulfasalazina [uso musculoesquelético] (producto), sulfasalazina [uso gastrointestinal], salazosulfapiridina, salicilazosulfapiridina, sulfasalazina (producto), sulfasalazina (sustancia), sulfasalazina, Salicilazosulfapiridina, Sulfasalazina
German Salicylazosulfapyridin, Sulfasalazin
Italian Sulfasalazina
Portuguese Salicilazossulfapiridina, Sulfassalazina

Ontology: Azulfidine (C0699547)

Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
MSH D012460
English Azulfidine EN-tabs, Pyralin EN, Salazopyrin, EN, Azulfidine, Azulfidine EN, Sulfasalazine Pfizer Brand, Pfizer Brand of Sulfasalazine, salazopyrin, azulfidine, azulfadine, Azulfidine, Asulfidine, Azulfadine