Active Ingredient: Budesonide
Budesonide is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age and in adults (older than 18 years of age).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 0.5 milligrams budesonide, 2 times daily, over the duration of 12 to 24 weeks. Afterwards, oral, 0.5 milligrams budesonide, once daily at morning.
The recommended daily dose is 1 mg budesonide to be administered as two separate doses per day: one dose of 0.5 mg budesonide in the morning and one dose of 0.5 mg budesonide in the evening.
The usual duration of induction treatment is 12 weeks. For patients who are not appropriately responding within 12 weeks, the treatment can be extended to up to 24 weeks. Patients with long-standing or extensive disease and higher levels of disease activity have an increased likelihood of requiring an extended induction phase.
The recommended daily dose is 0.5 mg budesonide to be administered as one dose of 0.5 mg budesonide in the morning, depending on the individual clinical requirement of the patient.
A maintenance dose of 0.5 mg budesonide twice daily is recommended for patients with a long-standing disease history and/or high extent of oesophageal inflammation in their acute disease state.
The duration of maintenance therapy is determined by the treating physician. Tapering of the dose is required after prolonged treatment. It is recommended to perform control endoscopies if symptoms persist or return. In addition, follow-up endoscopies are recommended in line with current clinical guidelines as symptoms may not reliably predict histological disease activity.
Drinking, eating or performing oral hygiene (e.g. brushing teeth and rinsing) should be avoided for at least 30 minutes after taking budesonide.
For:
Oral, 1 milligrams budesonide, 2 times daily, over the duration of 12 to 24 weeks. Afterwards, oral, 1 milligrams budesonide, once daily at morning.
The recommended daily dose is 2 mg budesonide to be administered as two separate doses per day: one dose of 1 mg budesonide in the morning and one dose of 1 mg budesonide in the evening.
The usual duration of induction treatment is 12 weeks. For patients who are not appropriately responding within 12 weeks, the treatment can be extended to up to 24 weeks. Patients with long-standing or extensive disease and higher levels of disease activity have an increased likelihood of requiring an extended induction phase.
The recommended daily dose is 1 mg budesonide to be administered as one dose of 1 mg budesonide in the morning, depending on the individual clinical requirement of the patient.
A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long-standing disease history and/or high extent of oesophageal inflammation in their acute disease state.
The duration of maintenance therapy is determined by the treating physician. Tapering of the dose is required after prolonged treatment. It is recommended to perform control endoscopies if symptoms persist or return. In addition, follow-up endoscopies are recommended in line with current clinical guidelines as symptoms may not reliably predict histological disease activity.
Drinking, eating or performing oral hygiene (e.g. brushing teeth and rinsing) should be avoided for at least 30 minutes after taking budesonide.
For:
Regimen A
Oral, 1 milligrams budesonide, 2 times daily, over the duration of 6 to 12 weeks. Afterwards, oral, 0.5 milligrams budesonide, 2 times daily at morning.
Regimen B
Oral, 1 milligrams budesonide, 2 times daily, over the duration of 6 to 12 weeks. Afterwards, oral, 1 milligrams budesonide, 2 times daily.
The recommended daily dose is 2 mg budesonide as 1 mg in the morning and 1 mg in the evening.
The usual duration of induction treatment is 6 weeks. For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks.
The recommended daily dose is 1 mg budesonide as 0.5 mg in the morning and 0.5 mg in the evening or 2 mg budesonide as 1 mg in the morning and 1 mg in the evening, depending on the individual clinical requirement of the patient. A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing disease history and/or high extent of esophageal inflammation in their acute disease state.
The duration of maintenance therapy is determined by the treating physician.
There should be at least 30 minutes before eating or drinking or performing oral hygiene. Any oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of budesonide.
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