Salofalk

Mesalazine

Gastro-resistant tab: Acute exacerbations of ulcerative colitis & Crohn's disease; relapse prophylaxis of ulcerative colitis. Supp: Acute episodes & maintenance of remission of ulcerative colitis that is limited to the rectum. Gastro-resistant PR granules: Acute episodes & maintenance of ulcerative colitis remission. Enema: Acute attacks of ulcerative colitis.

Gastro-resistant tab Adult Crohn's disease Acute episode: 1.5-4.5 g daily. Ulcerative colitis Acute episode: 1.5-3 g daily. Relapse prophylaxis/long-term therapy: 1.5 g daily. Supp Adult & elderly Ulcerative colitis Acute episode: Two 250 mg or one 500 mg supp inserted into the rectum tds. Remission maintenance: One 250 mg supp tds. Enema Adult & elderly Acute inflammation symptoms 2 enema bottles once daily at bedtime. Gastro-resistant PR granules Adult & elderly Ulcerative colitis Acute episode: 1.5-3 g once daily, preferably taken in the morning. Maintenance of remission: 0.5 g tds. Total dose: 1.5 g/day. Childn ≥6 yr Active disease 30-50 mg/kg/day once daily preferably in the morning or in divided doses. Max: 75 mg/kg/day. Total dose should not exceed the max adult dose. Maintenance: 15-30 mg/kg/day in divided doses. Total dose should not exceed the recommended adult dose. >40 kg Normal adult dose; ≤40 kg ½ the adult dose.

Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.

Hypersensitivity to salicylates or any of the excipients. Severe hepatic or renal impairment.

Discontinue use at the 1st appearance of signs & symptoms of severe skin reactions (eg, skin rash, mucosal lesions or any other hypersensitivity signs). Obtain blood tests (differential blood count, liver function parameters, serum creatinine) & urinary status prior to & during treatment. Possible nephrolithiasis; ensure adequate fluid intake during treatment. Patients w/ pulmonary disease particularly asthma; history of adverse drug reactions to prep containing sulphasalazine. Possible severe cutaneous AR including SJS & TEN. Immediately discontinue use if acute intolerance reactions (eg, abdominal cramps, acute abdominal pain, fever, severe headache & rash) occurs. Hepatic impairment. Not to be used in patients w/ renal impairment. Pregnancy & lactation. Gastro-resistant tab: Patients on low Na/salt diet. Not to be used in childn <6 yr. Supp: May cause local skin irritation due to cetyl alcohol content. Enema: Contains K metabisulphite which may rarely cause severe hypersensitivity reactions & bronchospasm. Contains Na benzoate which may cause local irritation. Gastro-resistant PR granules: Patients w/ phenylketonuria due to aspartame content.

Headache. Rarely, dizziness; myocarditis, pericarditis; abdominal pain, diarrhoea, flatulence, nausea, vomiting; photosensitivity. SJS & TEN.

Possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. May decrease anticoagulant effect of warfarin. Gastro-resistant PR granules: Lactulose or similar prep lowering stool pH (possible reduction of release from granules due to decreased pH caused by bacterial metabolism of lactulose).

GIT Regulators, Antiflatulents & Anti-Inflammatories

A07EC02 - mesalazine ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.

POM