Posology : מינונים

4.2    Posology and method of administration

Posology
Crohn’s disease
Adults aged > 18 years
The recommended daily dose is 9 mg budesonide: three capsules once daily in the morning or one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening; if this is more convenient to the patient, about ½ hour before meals.

Collagenous colitis
Adults aged > 18 years
The recommended dose is three capsules once daily in the morning before breakfast (corresponding to a daily dose of 9 mg budesonide).

Autoimmune hepatitis

Induction of remission (adults aged > 18 years)
For the induction of remission (i.e. normalisation of 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).

Maintenance of remission (adults aged > 18 years)
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.


All indications
Children
Budeson should not be taken by children younger than 12 years due to insufficient experience and possibly increased risk of adrenal suppression in this age group.

Adolescent patients
The safety and efficacy of Budeson in children aged 12 to 18 years have not yet been established. Currently available data in adolescent patients (12 - 18 years) with Crohn's disease or autoimmune hepatitis are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.

Method of administration
The capsules containing the gastro-resistant granules should be taken about half an hour before meals, swallowed whole not chewed with plenty of fluid (e.g. a glass of water).

Patients with swallowing difficulties can open the capsules and take the gastro- resistant granules directly, without chewing and with plenty of liquid. This does not impair the efficacy of Budeson capsules.

Duration of treatment
Crohn’s disease and collagenous colitis
The usual duration of treatment is 8 weeks.
The full effect is usually reached after 2-4 weeks.

Autoimmune hepatitis
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 be terminated only if biochemical remission is constantly maintained and if no signs of inflammation are present in a liver biopsy.

Termination of treatment
The treatment with Budeson 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.