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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.
Special care is needed in patients with lung tuberculosis and fungal or viral infections.
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chicken pox and measles, for example, can have a more serious or fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox develops, treatment with antiviral agents may be considered. If, however, a viral upper respiratory infection is present, the patient should adhere to the regular asthma medication. In patients who are known to deteriorate rapidly when they have viral respiratory infection, a short course of oral corticosteroid therapy should be considered.
Clinical studies have shown that viral infections cause significantly less problems in patients who are on regular treatment of topical glucocorticosteriods.
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 and itraconazole or other potent CYP3A4 inhibitors should be avoided (see Interactions). If this is not possible, the time interval between administration of the interacting drugs should be as long as possible.
Particular care is needed in patients transferring from oral glucocorticosteroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose emergency glucocorticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled glucocorticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic glucocorticosteroid cover should be considered during periods of stress or elective surgery.
During the transfer from oral steroid therapy to budesonide, patients may experience the return of previous symptoms such as 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 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. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist. Budesonide is not indicated for rapid relief of bronchospasm. Budesonide is therefore not suitable as sole therapy for the treatment of status asthmasticus or other acute exacerbations of asthma where intensive measures are required.
If patients find short-acting bronchodilator treatment ineffective or they need more inhalations than usual, medical attention must be sought. This indicates a worsening of the underlying conditions and warrants a reassessment of the therapy. Acute exacerbations of asthma may need complementary treatment with a short oral steroid regimen.
Decreased liver function may affect the ability to eliminate budesonide.
This product also contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose - galactose malabsorption should not take this medicine.
Warning for sportsmen: Sportsmen need to know that the medicine contains an active ingredient that gives positive results at an antidopping test.
Effects on ability to drive and use machines: Frenolyn is not known to have any effects on the ability to drive and use machines.
