Budenofalk Dosage/Direction for Use

Crohn's disease: Adults: The recommended daily dose is three capsules once daily in the morning or one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening).
Collagenous colitis: Adults (over 18 years): The recommended daily dose is three capsules once daily in the morning (corresponding to a daily dose of 9mg budesonide).
Autoimmune hepatitis: Adults (over 18 years): Induction of remission: For the induction of remission (i.e. for the normalisation of elevated liver enzymes), the recommended daily dose is 1 hard capsule 3 times daily (morning, midday and evening, equivalent to a total daily dose of 9 mg budesonide).
Maintenance of remission: Once remission has been achieved, a daily dose of 1 hard capsule twice daily (morning and evening, equivalent to a total daily dose of 6 mg budesonide) is recommended. If the transaminases ALT and/or AST increase during this treatment, the dose should be increased to 3 hard capsules daily, as for induction of remission (equivalent to a total daily dose of 9 mg budesonide).
In patients who tolerate azathioprine, budesonide should be combined with this drug for the induction and maintenance of remission.
Autoimmune liver cirrhosis: There is limited information on the efficacy of budesonide in cirrhosis patients, and such patients have higher frequency of steroid specific side effects. Budesonide should not be used in cirrhosis patients.
Children: Budenofalk 3 mg should not be given to children due to insufficient experience in this age group.
Adolescents: The safety and efficacy of Budenofalk 3 mg in children aged 12 to 18 years have not been established. Currently available data on adolescent patients (12 to 18 years of age) with autoimmune hepatitis are described in Adverse Reactions and Pharmacology: Pharmacodynamics under Actions. No dosage recommendations can be given, however.
Method of administration: The capsules should be taken before meals, swallowed whole with plenty of fluid (e.g. a glass of water).
Patients who have difficulty in swallowing capsules may open them and just take the gastro-resistant pellets whole with plenty of fluid. This will not impair the effectiveness of Budenofalk 3 mg.
Crohn's disease and collagenous colitis: The duration of treatment is generally 8 weeks.
As a rule, the full effect is achieved after 2-4 weeks.
Autoimmune hepatitis: After remission has been achieved, treatment of autoimmune hepatitis should be continued for at least 12 months. Beyond 12 months, if the biochemical remission is stable and liver biopsy does not reveal any signs of acute inflammation, decisions to continue budesonide or to stop therapy should be made on a case by case basis.
Budenofalk 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.