Gastro-resistant tab: Treatment of acute episodes & prevention of further episodes of ulcerative colitis. Treatment of acute episodes of Crohn's disease. Gastro-resistant PR granules: Treatment of acute episodes & prevention of further episodes of mild to moderate ulcerative colitis. Enema: Treatment of acute episodes of ulcerative colitis. Supp: Treatment of acute episodes & prevention of further episodes of chronic ulcerative colitis.
Gastro-resistant tab Adult & elderly Acute episodes of ulcerative colitis 250-mg tab 2-4 tab tds. 500-mg tab 1-2 tab tds. Prevention of recurrence/long-term treatment of ulcerative colitis 250-mg tab 2 tab tds. 500-mg tab 1 tab tds. Acute episode of Crohn's disease 250-mg tab 2-6 tab tds. 500-mg tab 1-3 tab tds. Childn ≥6 yr Acute episodes 30-50 mg/kg/day in divided doses. Max: 75 mg/kg/day. Total dose should not exceed the max adult dose. Prevention of relapse of ulcerative colitis 15-30 mg/kg/day in divided doses. Total dose should not exceed the recommended adult dose. Gastro-resistant PR granules 1,000 mg Adult, the elderly & childn >40 kg Treatment of acute episodes 3 sachets PO once daily (3 g/day) preferably in the morning, or 1 sachet PO tds. Prevention of further episodes for patients at increased risk for recurrence 3 sachets PO once daily (3 g/day) preferably in the morning. Childn ≥6 yr Treatment of acute episodes Initially 30-50 mg/kg/day once daily or in divided doses. Max: 75 mg/kg/day. Prevention of further episodes Initially 15-30 mg/kg/day in divided doses. Enema Adult & elderly 1 enema once daily. Supp Adult & elderly Treatment of acute episodes Insert two 250-mg OR one 500-mg supp into the rectum tds (in the morning, at midday & at bedtime) (equiv to 1,500 mg daily). Long-term prevention of recurrences One 250-mg supp into the rectum tds (equiv to 750 mg daily).
View Salofalk overdosage for action to be taken in the event of an overdose.
Administration
Should be taken on an empty stomach: Gastro-resistant tab: Take in the morning, at midday, & in the evening, 1 hr before meals. Swallow whole, do not chew, & take w/ plenty of fluid. Gastro-resistant PR granules: Place granules on the tongue & swallow w/ plenty of fluid. Do not chew.
Contraindications
Hypersensitivity to mesalazine, salicylic acid, salicylates or any of the excipients. Serious liver or kidney disease.
Patients w/ history of lung problems, particularly bronchial asthma; history of allergy to sulphasalazine; renal & hepatic impairment. Pregnancy & lactation. Childn. Gastro-resistant tab/PR granules/supp: Perform regular blood & urine tests during treatment. 500-mg gastro-resistant tab/PR granules/supp: Patients who developed severe skin rash or peeling, blistering &/or mouth sores after using mesalazine. Kidney stones may develop. Reports of serious skin reactions including DRESS, SJS & TEN. Gastro-resistant tab: Patients on a controlled Na diet. Gastro-resistant PR granules: Contains aspartame & sucrose. Enema: Contains K metabisulphite & Na benzoate.
Allergic skin rash, breathing difficulties, fever, sore throat & mouth. 250-mg gastro-resistant tab/supp: Rarely, abdominal pain, diarrhoea, flatulence, nausea & vomiting; headache, dizziness; chest pain, breathlessness or swollen limbs; photosensitivity. 500-mg gastro-resistant tab/PR granules: Headache. Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, nausea, vomiting; severe abdominal pain; changes in liver function parameters, & in pancreatic enzymes; changes in the number of WBC. Gastro-resistant PR granules: Itching. Supp: Reddish non-elevated, target-like or circular patches on the trunk, often w/ central blisters, skin peeling, ulcers of mouth, throat, nose, genitals, eyes.
Drug Interactions
Possible interactions w/ azathioprine, 6-mercaptopurine or thioguanine; blood clotting inhibitors eg, warfarin. Gastro-resistant PR granules: Possible interaction w/ lactulose or other prep that can change acidity of stools.
Sign Out
