Indications |
Oral Inflammatory bowel disease Adult: Initially, 1-2 g 4 times daily until remission occurs. Maintenance: 2 g/day in divided doses. Child: ≥2 yr: 40-60 mg/kg/day in divided doses. Maintenance: 20-30 mg/kg/day in divided doses.
Oral 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. 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 Adult: As suppository: 0.5-1 g in the morning and night, either alone or as an adjunct to oral treatment. As enema: 3 g at night, retained for at least 1 hr. 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. As enema (to be retained for at least 1 hr): 2-7 yr: 1-1.5 g; 7-12 yr: 1.5-2.25 g; 12-18 yr: 3 g, dose to be given at night. Special Populations: Dosing interval in renal impairment: CrCl 10-30 mL/min: Administer twice daily; <10 mL/min: Administer once daily. |
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Contraindications |
Hypersensitivity to sulphonamides or salicylates, porphyria, <2 yr of age, intestinal or urinary obstruction, blood dycrasias, history of leucopenia with gold therapy. | ||||||||||||
Warnings / Precautions |
Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation. | ||||||||||||
Adverse Reactions |
Headache, anorexia, nausea, vomiting, diarrhoea, abdominal discomfort, photosensitivity, crystalluria, reversible oligospermia, yellow-orange staining of contact lens, skin, urine and other body fluids, alopoecia. Potentially Fatal: Severe hypersensitivity reactions, blood dyscrasias, renal and hepatic toxicity, fibrosing alveolitis. |
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Overdose Reactions |
Nausea, vomiting, gastric distress, abdominal pains, drowsiness, convulsions. Gastric lavage or emesis plus catharsis as required. Alkalinize urine. If kidney function is normal, increase fluids. If anuria is present, restrict fluids and salt, and treat accordingly. Catheterization of the ureters may be needed for complete renal blockage by crystals. Hemodialysis may facilitate removal of sulfasalazine and its metabolites. Concentrations of serum sulfapyridine may be used to monitor the progress of recovery. | ||||||||||||
Drug Interactions |
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. See Below for More sulfasalazine Drug Interactions |
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Mechanism of Actions |
Actual mechanism not determined. Sulphasalazine may have direct anti-inflammatory action in the colon. It also systemically interferes with secretion by prostaglandin synthesis inhibition. Absorption: 15% of the dose is absorbed from small intestine, the rest reaches the colon where the azo bond is cleaved by the intestinal flora, producing sulfapyridine and 5-aminosalicylic acid (mesalazine). 60% of the sulfapyridine and 10-30% of the 5-aminosalicylic acid is absorbed from the colon. Distribution: Following IV admin, vol of distribution is 7.5 L. Sulfasalazine and sulfapyridine crosses the placenta and found in breast milk. Sulfasalazine is extensively protein bound while sulfapyridine is distributed to most body tissues. Metabolism: Absorbed sulfapyridine undergoes extensive metabolism by acetylation, hydroxylation, and glucuronidation. Slow acetylators are 2-3 times more likely to experience adverse effects from sulfapyridine compared to fast acetylators. Absorbed 5-aminosalicylic acid undergoes acetylation. Excretion: Via urine,as unchanged sulfasalazine (15%), sulfapyridine and its metabolites (60%), and 5-aminosalicylic acid and its metabolites (20-33%). |
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Administration |
Should be taken with food. (Take after meals. Ensure adequate fluid intake.) |
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Storage Conditions |
Oral: Store below 25°C. | ||||||||||||
ATC Classification |
A07EC01 - sulfasalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation. | ||||||||||||
Storage |
Oral: Store below 25°C. | ||||||||||||
Available As |
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Sulphasalazine
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Sulphasalazine Containing Brands
Sulphasalazine is used in following diseases
Drug - Drug Interactions of Sulphasalazine
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