Salofalk

Tab: Ulcerative colitis & proctitis (treatment of acute attack or to prevent relapse); Crohn's disease (acute attack). Granules: Acute episodes & maintenance of remission of mild to moderate ulcerative colitis.

Tab 1 tab in the morning, midday & in the evening 1 hr before meals. Granules Adult & elderly Acute episodes of ulcerative colitis 1-2 sachets once daily preferably in morning. Maintenance of ulcerative colitis remission 0.5 g tid (in the morning, midday & evening) corresponding to a total dose of 1.5 g daily. Patient known to be at increased risk for relapse 3 g as single daily dose, preferably in morning. Childn ≥6 yr Active disease Initially 30-50 mg/kg once daily, preferably in morning or in divided doses. Max: 75 mg/kg daily. Total dose should not exceed the max adult dose. Maintenance treatment Initially 15-30 mg/kg daily in divided doses. Total dose should not exceed the recommended adult dose.

Should be taken on an empty stomach: Tab: Take 1 hr before meals. Swallow whole, do not chew/crush. Granules: Place on the tongue & swallow, w/o chewing, w/ plenty of liqd.

Hypersensitivity to mesalazine, salicylic acid, salicylates & its derivatives. Severe hepatic or renal function impairment.

Patients w/ pulmonary function disturbances, particularly asthma; known hypersensitivity to prep containing sulfasalazine. W/draw treatment immediately in case of acute signs of intolerability eg, cramps, acute abdominal pain, fever, severe headache & skin rash. Determine blood tests (differential blood count; liver function parameters eg, transaminases; serum creatinine) & urine status (dip sticks/sediments) before & during treatment; perform follow-up tests 14 days after starting treatment, then a further 2-3 tests at intervals of 4 wk. If findings are normal, follow-up tests are required every 3 mth; if additional symptoms develop, perform tests immediately. Consider mesalazine-induced renal toxicity if renal function deteriorates during treatment. Not be used in patients w/ impaired renal function. Pregnancy & lactation. Granules: Patients w/ phenylketonuria; patients w/ impaired hepatic function. Reports of nephrolithiasis; ensure adequate fluid intake during treatment. Perform hematological investigations if patients suffer from unexplained hemorrhages, bruises, purpura, anemia, fever or pharyngolaryngeal pain. Discontinue in case of suspected or confirmed blood dyscrasia; cardiac hypersensitivity reactions (myocarditis & pericarditis); signs & symptoms of severe skin reactions. May produce red-brown urine discoloration after contact w/ Na hypochlorite bleach (eg, in toilets cleaned w/ Na hypochlorite contained in certain bleaches). Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Tab: Abdominal pain, diarrhea, flatulence, nausea, vomiting; headache, dizziness, peripheral neuropathy; renal impairment including acute & chronic interstitial nephritis & renal insufficiency; exanthema, drug fever, bronchospasm, pericarditis & myocarditis, pancreatitis, allergic & fibrotic lung reactions (including dyspnoea, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), butterfly rash (lupus erythematosus syndrome), pancolitis; myalgia, arthralgia; aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia; raised transaminase & parameters of cholestasis, hepatitis, cholestatic hepatitis; alopecia; reversible oligospermia. Granules: Headache; rash, pruritus.

Possible increase in myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Decreased anticoagulant effect of warfarin. Granules: Possible reduction of mesalazine 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.

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