Crohn's disease

Active Ingredient: Mesalazine

Indication for Mesalazine

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

For the maintenance of surgically-induced remission of Crohn’s Disease.

For this indication, competent medicine agencies globally authorize below treatments:

2.4 g per day

For:

Dosage regimens

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.

Detailed description

For the maintenance of surgically-induced remission of Crohn’s Disease.

Maintenance of remission: 2.4 g (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.

Dosage considerations

The gastro-resistant tablets must be swallowed whole preferably with some liquid before food intake.

30-50 mg/kg/day and thereafter 15-30 mg/kg/day in divided doses

For:

Dosage regimens

Tablet, delated release 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, tablet, delated release oral, between 15 milligrams mesalazine per kilogram of body weight and 30 milligrams mesalazine per kilogram of body weight, divided daily.

Detailed description

There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older

  • 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.

If one or more doses have been missed, the next dose is to be taken as usual.

Dosage considerations

The gastro-resistant tablets must be swallowed whole preferably with some liquid before food intake.

Active ingredient

Mesalazine

Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, but appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

Read more about Mesalazine

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