Budecort Special Precautions

Turbuhaler: In order to minimise the risk of Candida infections in the oral cavity and throat, the patient should be instructed to rinse the mouth with water after each dose administration.
Concomitant treatment with ketoconazole, itraconazole or other potent CYP3A4 inhibitors should be avoided. If this is not possible, the interval between the administrations of the drugs should be as long as possible.
Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Caution must be observed in treatment of patients who are transferred from systemically acting corticosteroids to Budesonide (BUDECORT) and in cases of suspected disturbance of pituitary-adrenocortical function. In these patients there should be a cautious reduction of the dose of systemic steroid, and tests of hypothalamic-pituitary-adrenocortical function should be considered. They may also require the adjunct of systemic steroids in connection with periods of stress, e.g. surgery, trauma, etc.
During the transfer from oral steroid therapy to Budesonide (BUDECORT TURBUHALER), patients may experience the return of previous symptoms such as muscle and joint pain. In these cases a temporary increase of the oral steroid dose may sometimes be necessary. If, in isolated cases, fatigue, headache, nausea, vomiting or similar symptoms occur, a generally unsatisfactory effect of the steroid should be suspected.
Replacement of systemic steroid treatment by Budesonide (BUDECORT TURBUHALER) sometimes reveals allergies, e.g. rhinitis and eczema, that were previously controlled by the systemic treatment.
Regular monitoring of growth is recommended in children and adolescents receiving long-term treatment with corticosteroids, irrespective of the administration form. The benefits of corticosteroid treatment must be placed in relation to possible risks of inhibition of growth.
Patients must be instructed to contact their physician if the effect of the treatment generally diminishes, as repeated inhalations for severe asthma attacks must not delay the initiation of other important therapy. If there is a sudden deterioration the treatment must be supplemented with a short course of oral steroids.
Respules: Budesonide (BUDECORT RESPULES) Nebulizing Suspension is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required.
If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought. In this situation consideration should be given to the need for increased anti-inflammatory therapy, eg, higher doses of inhaled budesonide or a course of oral glucocorticosteroid.
Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Some patients feel unwell in a non-specific way during the withdrawal phase, e.g., pain in muscles and joints. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases, a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies, e.g., rhinitis and eczema, which were previously controlled by the systemic drug. These allergies should be symptomatically controlled with an antihistamine and/or topical preparations.
Reduced liver function may affect the elimination of corticosteroids. This may be clinically relevant in patients with severely compromised liver function.
In vivo studies have shown that oral administration of ketoconazole and itraconazole (known inhibitors of CYP3A4 activity in the liver and in the intestinal mucosa, see also Interactions) may cause an increase of the systemic exposure to budesonide. This is of limited clinical importance for short-term (1 to 2 weeks) treatment but should be taken into consideration during long-term treatment.
The long-term local and systemic effects of Budesonide (BUDECORT RESPULES) Nebulizing Suspension in man are not completely known. The dose should be titrated to the lowest effective maintenance dose once control of asthma is achieved. Physicians should closely monitor the growth of children taking corticosteroids by any route and weigh the benefit of corticosteroid therapy and asthma control against the possibility of growth suppression.
Effects on ability to drive and use machines: Budesonide (BUDECORT TURBUHALER/RESPULES) has no effect on the ability to drive and use machines.