Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.
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
Indication
Inflammatory bowel disease, Rheumatoid arthritis
Contra Indication
Hypersensitivity to sulphonamides or salicylates, porphyria, <2 yr of age, intestinal or urinary obstruction, blood dycrasias, history of leucopenia with gold therapy.
Dose
N/A
Side Effect
>10%
Anorexia (~33%),Headache (~33%),Nausea (~33%),Vomiting (~33%),Gastric distress (~33%),Apparently reversible oligospermia (~33%)
<1%
Skin rash,Pruritus,Urticaria,Fever,Heinz body anemia,Hemolytic anemia,Cyanosis
Potentially Fatal: Severe hypersensitivity reactions, blood dyscrasias, renal and hepatic toxicity, fibrosing alveolitis.
Pregnancy Category
Name :
B
Description
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Mode of Action
Actual mechanism not determined. Sulphasalazine may have direct anti-inflammatory action in the colon. It also systemically interferes with secretion by prostaglandin synthesis inhibition.
Interaction
Plasma levels reduced by rifampicin and ethambutol. Interferes with absorption of folic acid. Additive leucopaenia with gold therapy for rheumatoid arthritis. Increased haematological toxicity with azathioprine. Reduced serum levels of digoxin.
Pregnancy Category Note
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
Adult Dose
Oral
Inflammatory bowel disease
Adult: Initially, 1-2 g 4 times daily until remission occurs. Maintenance: 2 g/day in divided doses.
Rheumatoid arthritis
Adult: As enteric-coated tablet: Initially, 500 mg daily for the 1st wk increased by 500 mg every wk. Max: 3 g daily in 2-4 divided doses.
Rectal
Inflammatory bowel disease
Adult: As suppository: 0.5-1 g in the morning and night, either alone or as an adjunct to oral treatment.
Hepatic impairment: Avoid use.
Child Dose
Oral
Inflammatory bowel disease
Child: >2 yr: 40-60 mg/kg/day in divided doses. Maintenance: 20-30 mg/kg/day in divided doses.
Rheumatoid arthritis
Child: For polyarticular juvenile rheumatoid arthritis: >6 yr: As enteric-coated tablet: 30-50 mg/kg/day in 2 divided doses. Begin treatment with 1/4 to 2/3 of expected maintenance dose and increase wkly to reach maintenance dose in 1 mth. Max: 2 g daily.
Rectal
Inflammatory bowel disease
Child: As suppository (may be given as divided doses): 5-8 yr: 500 mg bid; 8-12 yr: 500 mg in the morning and 1 g at night; 12-18 yr: 1 g bid.
Should be taken with food. Take after meals. Ensure adequate fluid intake.
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