Classes
DEA Class; Rx
Common Brand Names; Azulfidine, Azulfidine EN
- 5-Aminosalicylic Acid Derivatives;
- DMARDs, Other
Description
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
Indications
Indicated for the treatment of mild to moderate ulcerative colitis and as an adjunct for severe ulcerative colitis.
Contraindications
Hypersensitivity to sulfasalazine or its metabolites, to sulfonamides, or to salicylates
Intestinal or urinary tract obstruction
Porphyria
Adverse Effects
- 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
Warnings
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 and Lactation
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
Maximum Dosage
4 grams/day PO for ulcerative colitis; 3 grams/day PO for rheumatoid arthritis.
4 grams/day PO for ulcerative colitis; 3 grams/day PO for rheumatoid arthritis.
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).
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.
Safety and efficacy have not been established.
How supplied
Sulfasalazine
tablet
- 500mg
tablet, enteric coated (delayed release)
- 500mg
