Flixotide Special Precautions





Agencia Lei Va Hong
Full Prescribing Info
Special Precautions
The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to increasing corticosteroid dosage. In patients considered at risk, daily peak flow monitoring may be instituted.
Lack of response or severe exacerbations of asthma may be an indication for review of the patient. Treatment options may include increasing the dose of inhaled FLIXOTIDE and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection.
FLIXOTIDE is not for use in acute asthma attacks, but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms.
Treatment with FLIXOTIDE should not be stopped abruptly.
There have been very rare reports of increases in blood glucose levels (see Adverse Reactions) and this should be considered when prescribing to patients with a history of diabetes mellitus.
As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.
A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects (see Interactions).
As with other inhalation therapy, paradoxical bronchospasm may occur rarely, with an immediate increase in wheezing after dosing. This should be treated immediately with a fast and short-acting inhaled bronchodilator. FLIXOTIDE should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted if necessary.
Patients' inhaler technique should be checked to make sure that inhaler actuation is synchronised with inspiration to ensure optimum delivery of the drug to the lungs.
Spacer Devices: Most patients will benefit from the consistent use of a spacer device with their metered dose inhaler (MDI), particularly those with poor inhaler technique. Use of a spacer will also decrease the amount of drug deposited in the mouth and back of the throat, and therefore reduce the incidence of local side effects such as 'thrush' and a hoarse voice.
A change in the make of spacer may be associated with alterations in the amount of drug delivered to the lungs. The clinical significance of these alterations is uncertain. However, in these situations, the person should be monitored for any loss of asthma control.
If using a spacer, the patient should be instructed to actuate the inhaler into the spacer and then slowly breathe in as far as possible. Hold the breath for as long as comfortable, before breathing out slowly. This should be repeated for each actuation of the drug into the spacer. Any delays between actuation and inhalation should be kept to a minimum.
Static on the walls of the spacer may cause variability in drug delivery. Patients should be instructed to wash the spacer in warm water and detergent and allow it to air dry without rinsing or drying with a cloth. This should be performed before initial use of the spacer and at least monthly thereafter.
Possible systemic effects, including Adrenocortical function, Bone density and Growth: Inhaled steroids are designed to direct glucocorticoid delivery to the lungs in order to reduce overall systemic glucocorticoid exposure and side effects. With sufficient doses however, all inhaled steroids can have adverse effects; possible systemic effects include Cushing's syndrome, Cushingoid features, depression of the hypothalamic-pituitary adrenal (HPA) axis, reduction of bone density, retardation of growth rate, cataract and glaucoma (see Overdosage).
The lowest doses of inhaled corticosteroids that cause suppression of the HPA axis (as indicated by the 24 hour urinary cortisol concentrations), effects on bone mineral density or growth retardation in children has not yet been established. Some depression of plasma cortisol may occur in a small number of adult patients receiving inhaled FLIXOTIDE at recommended and higher doses but it is not possible to predict which patients are at risk based solely on dose, previous history or length of exposure to inhaled or oral steroids. Adrenal function and adrenal reserve usually remain within normal range on inhaled FLIXOTIDE therapy. To minimise the systemic effects of orally inhaled corticosteroids, including FLIXOTIDE, each patient should be titrated down to the lowest dose that effectively controls his/her asthma (see Dosage & Administration).
Medical Emergency: Patients in a medical or surgical emergency, who in the past have required high doses of other inhaled steroids and/or intermittent treatment with oral steroids, remain at risk of impaired adrenal reserve for a considerable time after transferring to inhaled FLIXOTIDE. The extent of the adrenal impairment may require specialist advice before elective procedures. The possibility of residual impaired adrenal response should always be borne in mind in emergency and elective situations likely to produce stress and appropriate corticosteroid treatment must be considered (see Overdosage).
Transfer of patients being treated with oral corticosteroids: Because of the possibility of impaired adrenal response, patients transferring from oral steroid therapy to inhaled FLIXOTIDE therapy should be treated with special care and adrenocortical function regularly monitored.
Following introduction of inhaled FLIXOTIDE, withdrawal of systemic therapy should be gradual and patients whose adrenocortical function is still impaired should carry a steroid warning card indicating that they may need supplementary systemic steroid during periods of stress, e.g. worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma, etc.
In rare cases inhaled therapy may unmask underlying eosinophilic conditions (e.g. Churg-Strauss syndrome). These cases have usually been associated with reduction or withdrawal of oral corticosteroid therapy. A direct causal relationship has not been established.
Similarly, replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids.
Effects on ability to drive and use machines: FLIXOTIDE is unlikely to produce an effect.
Use in Children: The growth of paediatric patients receiving corticosteroids, including FLIXOTIDE, should be monitored. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained.
In children taking recommended doses of inhaled FLIXOTIDE, adrenal function and adrenal reserve usually remain within the normal range. However, the possible effects of previous or intermittent treatment with oral steroids should not be discounted. Nevertheless, the benefits of inhaled FLIXOTIDE should minimise the need for oral steroids.
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