Flixotide Special Precautions





Zuellig Pharma
Full Prescribing Info
Special Precautions
Increasing use of short-acting inhaled beta2-agonists to control asthma 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.
FLIXOTIDE is not for use in acute attacks, but for routine long-term management. Patients will require a fast- and short- acting inhaled bronchodilator to relieve acute asthmatic symptoms.
Lack of response or severe exacerbations of asthma should be treated by increasing the dose of inhaled FLIXOTIDE and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection.
There was an increased reporting of pneumonia in studies of patients with COPD receiving FLIXOTIDE 500 micrograms (see Adverse Reactions). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods; these effects are much less likely to occur than with oral corticosteroids (see Overdosage). Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, and central serous chorioretinopathy. It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained (see Adverse Reactions).
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
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 encouraged to carry a steroid warning card indicating the possible need for additional therapy in times of stress.
The possibility of impaired adrenal response should always be considered in emergency situations (including surgery), and also in elective situations likely to produce stress, especially in patients taking high doses for an extended duration of time. Additional corticosteroid treatment appropriate to a given clinical situation must be considered (see Overdosage).
Similarly replacement of systemic steroid treatment with inhaled therapy may unmask 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.
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.
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 with an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. FLIXOTIDE Evohaler should be discontinued immediately, the patient assessed, and alternative therapy instituted if necessary (see Adverse Reactions).
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.
Effects on Ability to Drive and Use Machines: FLIXOTIDE is unlikely to produce an effect.
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