Sulfasalazine is used in the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease. It is also indicated for use in rheumatoid arthritis and used in other types of inflammatory arthritis (e.g. psoriatic arthritis and reactive arthritis).
Sulfonamide; Anti-inflammatory
The mode of action of Sulfasalazine is still under investigation, but may be related to the anti inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.
ORAL Rheumatoid arthritis: Adult: As entericcoated tablet: Initially, 500 mg daily for the 1st wk increased by 500 mg every wk. Max: 3 g daily in 2-4 divided doses. Child: For polyarticular juvenile rheumatoid arthritis: 6 yr: As enteric-coated tablet: 30-50 mg/kg/day in 2 divided doses. Begin treatment w/ to 2/3 of expected maintenance dose & increase wkly to reach maintenance dose in 1 mth. Max: 2 g daily.
Reduced absorption of folic acid and digoxin has been reported when those agents were administered concomitantly with sulfasalazine.
Hypersensitivity to sulphonamides or salicylates. porphyria, <2 yr of age, intestinal or urinary obstruction, blood dycrasias, history of leucopenia w/ gold therapy. Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.
Headache, anorexia, nausea, vomiting, diarrhoea, abdominal discomfort, photosensitivity, crystalluria, reversible oligospermia. yellow-orange staining of contact lens, skin, urine & other body fluids, alopoecia. Severe hypersensitivity reactions, blood dyscrasias, renal & hepatic toxicity, fibrosinq alveolitis.
This drug should be used during pregnancy only if clearly needed. Sulfasalazine and its active metabolite mesalamine are poorly excreted into breastmilk. However, rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. Another sulfasalazine metabolite, sulfapyridine, also appears in milk and infant serum and might cause hemolysis, especially in newborn infants and in those with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The time of greatest risk for hemolysis in fullterm newborns without G6PD deficiency might be as short as 8 days after birth. Bloody diarrhea has occurred in an infant whose mother was taking sulfasalazine and a few cases of diarrhea have been reported in infants exposed to mesalamine in breastmilk, although the rate is not high. Most experts consider mesalamine derivatives to be safe during breastfeeding. If sulfasalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea. Other mesalamine derivatives that do not contain a sulfonamide are preferred.
Store in a cool and dry place, protected from light.
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