Sulfasalazine

Aka: Sulfasalazine, Azulfidine, Olsalazine, Dipentum

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II. Mechanism

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

III. Indications

  1. Inflammatory Bowel Disease (e.g. Ulcerative Colitis)
  2. Early Rheumatoid Arthritis (especially seronegative)
  3. Psoriatic Arthritis
  4. Arthritis in Reiter's Syndrome

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

IX. 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]

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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
FPNotebook does not benefit financially from showing this medication data or their pharmacy links. This information is provided only to help medical providers and their patients see relative costs. Insurance plans negotiate lower medication prices with suppliers. Prices shown here are out of pocket, non-negotiated rates. See Needy Meds for financial assistance information.

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
Russian SALITSILAZOSUL'FAPIRIDIN, SUL'FASALAZIN, SALAZOSUL'FAPIRIDIN, САЛАЗОСУЛЬФАПИРИДИН, САЛИЦИЛАЗОСУЛЬФАПИРИДИН, СУЛЬФАСАЛАЗИН
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
Croatian SULFASALAZIN
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
Derived from the NIH UMLS (Unified Medical Language System)

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
Derived from the NIH UMLS (Unified Medical Language System)

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