Juvenile rheumatoid arthritis, Poly-articular course.
Rheumatoid arthritis.
Ulcerative colitis, Prolongation of remission between episodes.
Ulcerative colitis, Treatment of mild to moderate disease.
Ulcerative colitis, Treatment of severe disease; Adjunct.

5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF); action appears topical rather than systemic.(UTD)

Absorption:
Sulfasalazine, Bioavailability, oral: less than 15%
Distribution:
Sulfasalazine, Vd: 7.5 +/- 1.6 L
Metabolism:
Hepatic: minimal .
Excretion:
Renal: primarily sulfapyridine and absorbed 5-aminosalicylic acid unchanged or as glucuronide conjugates.
Elimination Half Life:
Sulfasalazine: 7.6 hr .

Hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates
Intestinal or urinary obstruction
Porphyria .

B (FDA) A (AUS)

Drugs that have been associated with significant effects on some nursing infants and should be given to nursing mothers with caution.( AAP)
Avoid breastfeeding if possible. Monitor infant for side effects.(WHO)
Milk effects are possible.(MDX)

>10%:
Central nervous system: Headache (RA 9%)
Dermatologic: Skin rash (RA 13%)
Gastrointestinal: Nausea (RA 19%), dyspepsia (RA 13%), anorexia, gastric distress, vomiting
Genitourinary: Oligospermia (reversible)
1% to 10%:
Central nervous system: Dizziness
Dermatologic: Pruritus (RA 4%), urticaria
Gastrointestinal: Abdominal pain (RA 8%), stomatitis (RA 4%)
Hematologic & oncologic: Leukopenia (RA 3%), thrombocytopenia (RA 1%), Heinz body anemia, hemolytic anemia
Hepatic: Abnormal hepatic function tests (RA 4%)
Respiratory: Cyanosis
Miscellaneous: Fever(UTD)

Rheumatoid arthritis: Oral: Enteric coated tablet: Initial: 0.5 to 1 g daily; increase weekly to maintenance dose of 2 g daily in 2 divided doses; maximum: 3 g daily (if response to 2 g daily is inadequate after 12 weeks of treatment)
Ulcerative colitis:
Initial: 3 to 4 g daily in evenly divided doses at ?8-hour intervals; may initiate therapy with 1 to 2 g daily to reduce GI intolerance. Note: American College of Gastroenterology guideline recommendations: Titrate to 4 to 6 g daily in 4 divided doses .
Maintenance dose: 2 g daily in evenly divided doses at ?8-hour intervals; if GI intolerance occurs reduce dosage by 50% and gradually increase to target dose after several days. If GI intolerance persists, stop drug for 5 to 7 days and reintroduce at a lower daily dose.
Crohn disease, active mild/moderate, ileocolonic or colonic disease (off-label use): 3 to 6 g daily in divided doses.

Juvenile rheumatoid arthritis, Poly-articular course:
(Delayed release tablets, 6 years or older) 30 to 50 mg/kg/day in 2 evenly divided doses; to reduce gastrointestinal intolerance, begin with a quarter to a third of the planned maintenance dose and increase weekly until attaining the maintenance dose at 1 month; MAX 2 g/day
Ulcerative colitis, Prolongation of remission between episodes:
(6 years or older) Initial, 40 to 60 mg/kg/day orally divided into 3 to 6 doses; adjust to individual response and tolerance.
(6 years or older) Maintenance, 30 mg/kg/day orally divided into 4 doses
Ulcerative colitis, Treatment of mild to moderate disease:
(6 years or older) Initial, 40 to 60 mg/kg/day orally divided into 3 to 6 doses; adjust to individual response and tolerance
(6 years or older) Maintenance, 30 mg/kg/day orally divided into 4 doses
Ulcerative colitis, Treatment of severe disease; Adjunct:
(6 years or older) Initial, 40 to 60 mg/kg/day orally divided into 3 to 6 doses; adjust to individual response and tolerance
(6 years or older) Maintenance, 30 mg/kg/day orally divided into 4 doses .