Salazine 500 - Tablet Sulfasalazine - 500mg 10 Tablet(s) / Strip Opsonin Pharma Limited Introduction: Salazine 500 is a medicine used to treat various inflammatory conditions of the joints (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), skin (psoriasis), and bowel (ulcerative colitis, Crohn’s disease). Salazine 500 is to be taken with food. This will help you prevent an upset stomach. You should take it regularly and at the same time each day to get the maximum benefit from it. Keep taking it as recommended by your doctor and complete the dose even if you feel better. Taking it with plenty of water can help you avoid kidney problems such as kidney stones. Using this medicine may... Uses of Salazine 500: Rheumatoid arthritisUlcerative colitisCrohn’s diseaseAnkylosing spondylitis Side effects of Salazine 500: DiarrheaGastrointestinal discomfortHeadacheLoss of appetiteNauseaOligospermia (low sperm count)VomitingWeight loss How to use Salazine 500: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Salazine 500 is to be taken with food. How Salazine 500 works: Salazine 500 is a Disease Modifying Anti-Rheumatoid Drug (DMARD). It works by suppressing the overactivity of the immune system in autoimmune diseases and blocks the chemical messengers that cause inflammation (swelling). What if you forget to take Salazine 500?: If you miss a dose of Salazine 500, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Inflammatory bowel disease, Rheumatoid arthritis Administration: Should be taken with food. Take after meals. Ensure adequate fluid intake. 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. Renal Dose: Renal impairment: CrCl (ml/min) Dosage Recommendation 10-30ml/min Admin twice daily. <10ml/min Admin once daily. Contraindication: Hypersensitivity to sulphonamides or salicylates, porphyria, <2 yr of age, intestinal or urinary obstruction, blood dycrasias, history of leucopenia with gold therapy. 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. Precaution: 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 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 Note: Pregnancy category: B; D if used for prolonged periods or near term; increased potential for kernicterus in the newborn 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.