Budenofalk Special Precautions

Treatment with Budenofalk 3 mg results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. Transfer from other glucocorticosteroid therapy may therefore result in symptoms relating to the change in systemic steroid levels.
Particularly close medical supervision is required in patients suffering from one or more of the following diseases: tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer (gastric or duodenal), glaucoma, cataract, family history of diabetes or glaucoma or any other condition in which glucocorticosteroids may have undesirable effects.
This medicine is not appropriate for patients suffering from Crohn's disease of the upper gastrointestinal tract.
Due to the preferential local mode of action of the compound beneficial effects for patients suffering from extraintestinal symptoms (e.g. of the eyes, skin, joints) cannot be expected.
Systemic effects of glucocorticosteroids may occur, particularly when prescribed at high doses and for prolonged periods. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric/behavioural effects.
Bone mineral density measurements should be performed regularly on patients who are on budesonide for more than 6 months.
Infections: Suppression of the inflammatory response and immune system increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticosteroid treatment should be carefully considered. The clinical presentation can be atypical and serious infections such as sepsis and tuberculosis may be masked and may reach an advanced stage before being recognised.
Chickenpox is of particular concern because this illness may be severe or even fatal in immunosuppressed patients. Patients without a definite history of this disease should be advised to avoid close personal contact with chickenpox or shingles (herpes zoster) and, if exposed, they should seek urgent medical attention. Passive immunisation with varicella zoster immunoglobulin (VZIG) is indicated for exposed non-immune patients who are receiving systemic glucocorticosteroids or who have used them within the previous 3 months, and should be given within 10 days of exposure to chickenpox. If chickenpox is confirmed, the illness requires immediate, specialist treatment. Patients with compromised immunity who have come into contact with measles should, wherever possible, receive normal immunoglobulin as soon as possible after exposure.
Vaccines: Live vaccines should not be used in persons with with chronic glucocorticosteroid use. The antibody response to other vaccines (killed vaccines) may be diminished.
Patients with liver function disorders: Based on the experience with patients suffering from late stage primary biliary cirrhosis (PBC) with hepatic cirrhosis, an increased systemic availability of budesonide in all patients with severely impaired hepatic function is to be expected.
However, in patients with liver disease without hepatic cirrhosis, budesonide in daily doses of 9 mg was safe and well tolerated. There is no evidence that a specific dose recommendation for patients with non-cirrhotic liver diseases or only slightly impaired liver function is necessary.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Others: In patients with autoimmune hepatitis, serum transaminase levels (ALT, AST) should be regularly monitored (every 2 weeks for the first month of treatment and at least every 3 months thereafter), in order to facilitate dose adjustments of budesonide.
The elimination of Budenofalk 3 mg and that of other glucocorticosteroids may be reduced in patients with severe hepatic dysfunction, and systemic bioavailability increased; therefore these patients should not be treated with budesonide.
Budenofalk 3 mg can suppress the response of the hypothalamo-pituitary-adrenal axis to stress. For this reason, a supplementary systemic glucocorticoid should be given to patients undergoing surgery or other stresses.
Concomitant treatment with ketoconazole or other CYP3A inhibitors should be avoided (see Interactions).
Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, sucrase isomaltase insufficiency or glucose galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.