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  • Flixotide Inhaler CFC Free
    / GSK


    Active Ingredient
    Fluticasone Propionate 50, 125, 250 mcg/dose

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suspension for Inhalation

    50 mcg/dose

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    Suspension for Inhalation

    125 mcg/dose

    partial basket chart 2761 6169

    Suspension for Inhalation

    250 mcg/dose

    partial basket chart 2762 6170

    Dosage

    Flixotide Inhaler is for inhalation by oral inhalation only.
    Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. The onset of therapeutic effect is 4 to 7 days, although some benefit may be apparent as soon as 24 hours for patients who have not previously received inhaled steroids.
    The dosage of fluticasone propionate should be adjusted according to the individual response.
    If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
    It is intended that each prescribed dose is given by a minimum of 2 inhalations.
    In patients who find co-ordination of a pressurised metered-dose inhaler difficult a spacer may be used with Flixotide inhaler.
    See prescribing information for full details.


    Indications

    Flixotide inhaler 50, 125, 250 mcg is indicated for the prophylactic management of all grades of asthma.
    Flixotide inhaler 50 mcg is also indicated for children aged 1 to 4 years for the control of persistent asthma symptoms.
    Flixotide inhaler 250 mcg is also indicated for the symptomatic treatment of chronic obstructive pulmonary disease (COPD).


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    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 β2-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 Inhaler 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.
    Lack of response or severe exacerbations of asthma should be treated by increasing the dose of inhaled fluticasone propionate and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection.
    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. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
    It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
    Certain individuals can show greater susceptibility to the effects of inhaled corticosteroid than do most patients.
    Because of the possibility of impaired adrenal response, patients transferring from oral steroid therapy to inhaled fluticasone propionate therapy should be treated with special care, and adrenocortical function regularly monitored.
    Following introduction of inhaled fluticasone propionate, withdrawal of systemic therapy should be gradual.
    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 Inhaler should not be stopped abruptly.
    There have been very rare reports of increases in blood glucose levels 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.
    The possibility of impaired adrenal response should always be borne in mind in emergency situations, including surgery, and elective situations likely to produce stress and appropriate corticosteroid treatment must be considered.
    Adrenal function and adrenal reserve usually remain within the normal range on recommended doses of fluticasone propionate therapy. The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids. However, the possibility of adverse effects in patients, resulting from prior or
    intermittent administration of oral steroids, may persist for some time. The extent of the adrenal impairment may require specialist advice before elective procedures.
    There was an increased reporting of pneumonia in studies of patients with COPD receiving FP 500 micrograms. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap.
    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.
    Fluticasone propionate should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.
    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.


    Side Effects

    Very common: Candidiasis of mouth and throat.
    Common: Pneumonia (in COPD patients), Hoarseness, Contusions.
    See prescribing information for full details.


    Drug interactions

    Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450
    3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
    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 intranasal or inhaled 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.
    Studies have shown that other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and minor (ketoconazole) increases in systemic exposure to fluticasone propionate without notable reductions in serum cortisol concentrations. Nevertheless, care is advised when co-administering potent cytochrome P450 3A4 inhibitors (e.g. ketoconazole) as there is potential for increased systemic exposure to fluticasone propionate.


    Pregnancy and Lactation

    Pregnancy: There are limited data in pregnant women. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
    Breast-feeding: The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone propionate in the breast milk. However, plasma levels in patients following inhaled application of fluticasone propionate at recommended doses are likely to be low.
    Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
    See prescribing information for full details.


    Overdose

    Symptoms and signs: Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action, as normal adrenal function typically recovers within a few days.
    If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis occurring in children exposed to higher than approved doses (typically 1000 micrograms daily and above), over prolonged periods (several months or years); observed features included hypoglycaemia and sequelae of decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma,
    surgery, infection or any rapid reduction in dosage.
    Treatment: Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.


    Important notes

    Storage: Do not store above 30°C. Protect from frost and direct sunlight.


    Manufacturer
    Glaxo Wellcome SA, SPAIN
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