Active Ingredient: Budesonide
For this indication, competent medicine agencies globally authorize below treatments:
Oral
9 - 9 mg
From 3 To 3 mg 3 time(s) per day every day for 730 day(s)
9 mg
6 mg
For the induction of remission (i.e. normalisation of elevated laboratory parameters) the recommended daily dose is one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening; corresponding to a total daily dose of 9 mg budesonide).
After achievement of remission the recommended daily dose is one capsule (containing 3 mg budesonide) twice daily (one capsule in the morning and one capsule in the evening; corresponding to a total daily dose of 6 mg budesonide).
If the transaminases ALAT and/or ASAT increase during maintenance treatment, the dose should be increased to 3 capsules per day (corresponding to a total daily dose of 9 mg budesonide) as described for induction of remission.
In patients tolerant to azathioprine, treatment for induction and maintenance of remission with budesonide should be combined with azathioprine.
For the induction of remission, a total daily dose of 9 mg should be given until remission is achieved. Thereafter, for maintenance of remission a total daily dose of 6 mg budesonide should be given. Treatment for maintenance of remission in autoimmune hepatitis should be continued at least for 24 months. It might beterminated only if biochemical remission is constantly maintained and if no signs of inflammation are present in a liver biopsy.
The treatment with budesonide 3 mg should not be stopped abruptly, but withdrawn gradually (tapering doses). In the first week, the dosage should be reduced to two capsules daily, one in the morning, one in the evening. In the second week, only one capsule should be taken in the morning. Afterwards treatment can be stopped.
Should be taken about half an hour before meals.
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