Budenofalk Rectal Foam Special Precautions

Treatment with Budenofalk rectal foam results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy with systemically acting corticoids. Transfer from another glucocorticosteroid therapy may result in reappearance or recurrence of symptoms relating to the change in systemic steroid levels.
Caution is required in patients suffering from one or several of the following diseases: tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer (gastric or duodenal ulcer), glaucoma, cataract, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticosteroids may have undesirable effects.
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 (see Adverse Reactions).
Infections: Suppression of the inflammatory response and immune function 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 may often be atypical and serious infections such as septicaemia and tuberculosis may be masked, and therefore may reach an advanced stage before being recognised.
Chickenpox is of particular concern since this illness may be serious or fatal in immunosuppressed patients. Patients without a definite history of chickenpox should be advised to avoid close contact with persons suffering from chickenpox or shingles (herpes zoster) and, if exposed, they should seek urgent medical attention. Passive immunisation with varicella-zoster immunoglobulin is needed by exposed non-immunised patients who are receiving systemic glucocorticosteroids or who have used them within the previous 3 months. Immunisation should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Glucocorticosteroids should not be stopped and the dose may need to be increased. Corresponding precautionary measures must also be taken for a possible infection with measles.
Vaccines: Live vaccines should not be given to individuals with chronic glucocorticosteroid use. The antibody response to other(inactivated) 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 oral 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: Budenofalk rectal foam may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is recommended.
Concomitant treatment with ketoconazole or other CYP3A inhibitors should be avoided because inhibition of the oxidative biotransformation of budesonide can result in elevated plasma levels of budesonide (see Interactions).
It should also be noted that systemic glucocorticoid-like side effects can occur with doses that are higher than recommended (see Adverse Reactions).
Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation. Budenofalk rectal foam does not contain preservatives.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Due to insufficient experience, Budenofalk rectal foam should not be used in children and adolescents.