Active Ingredient: Mesalazine
For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis.
For maintenance of remission.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Rectal, 2 grams mesalazine, divided daily.
Active treatment: 1 g mesalazine twice daily for two to four weeks.
Maintenance treatment: 1-2 g mesalazine daily.
For:
Regimen A: Granule, delayed release oral, between 2 grams mesalazine and 4 grams mesalazine, divided daily. Afterwards, granule, delayed release oral, 2 grams mesalazine, once daily.
Regimen B: Tablet, extended release oral, between 2.4 grams mesalazine and 4.8 grams mesalazine, divided daily to meals. The maximum allowed total dose is 4.8 grams mesalazine daily. Afterwards, tablet, extended release oral, 2.4 grams mesalazine, once daily to meals.
Regimen C: Tablet, delated release oral, between 2.4 grams mesalazine and 4.8 grams mesalazine, divided daily. Afterwards, tablet, delated release oral, between 1.2 grams mesalazine and 2.4 grams mesalazine, divided daily.
Active disease: Individual dosage, up to 4 g mesalazine once daily or divided into 2-4 doses.
Maintenance treatment: Individual dosage. Recommended dosage, 2 g mesalazine once daily.
For induction of remission: 2.4 to 4.8 g should be taken once daily. The highest dose of 4.8 g/day is recommended for patients not responding to lower doses of mesalazine. When using the highest dose (4.8 g/day), the effect of the treatment should be evaluated at 8 weeks.
For maintenance of remission: 2.4 g should be taken once daily.
Induction of remission: 2.4 g (3 tablets) per day once daily or in divided doses. If required the dose may be increased to 4.8 g (6 tablets) per day in divided doses. Above 2.4 g daily in divided doses only. The dosage can be adjusted in accordance with the response to the treatment.
Maintenance of remission: 1.6 to 2.4 g (2 to 3 tablets) per day once daily or in divided doses.
If one or more doses have been missed, the next dose is to be taken as usual.
The granules should be emptied onto the tongue and washed down with some water or orange juice. Alternatively they can be taken with yogurt and consumed immediately.
The gastro-resistant, prolonged release tablets must not be crushed or chewed and should be taken with food.
The gastro-resistant tablets must be swallowed whole preferably with some liquid before food intake.
For:
Oral, between 30 milligrams mesalazine per kilogram of body weight and 50 milligrams mesalazine per kilogram of body weight, divided daily. The maximum allowed total dose is 75 milligrams mesalazine per kilogram of body weight daily. Afterwards, oral, between 15 milligrams mesalazine per kilogram of body weight and 30 milligrams mesalazine per kilogram of body weight, divided daily.
The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).
Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4.0 g/day.
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2.0 g/day.
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
The granules should be emptied onto the tongue and washed down with some water or orange juice. Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately.
The gastro-resistant tablets must be swallowed whole preferably with some liquid before food intake.
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