Presentation and Status in Health Basket
Suspension for Inhalation
0.5 mg / 2 ml
Suspension for Inhalation
2 mg/ 2 ml
Adults and adolescents over 16 years: 500-2,000 micrograms twice daily. Prescribers should be aware that fluticasone propionate is as effective as other inhaled steroids approximately at half the microgram daily dose. For example, a 100mcg of fluticasone propionate is approximately equivalent to 200mcg dose of beclometasone dipropionate (CFC containing) or budesonide.
Prescribers should be aware of the risks of systemic effects when using high doses of corticosteroids.
Patients should be given a starting dose of inhaled fluticasone propionate, which is appropriate to the severity of their disease.
The dose should be titrated down to the lowest dose at which effective control of asthma is maintained.
Children and adolescents from 4 to 16 years of age: 1000 mcg twice daily
Special patient groups: There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment.
Flixotide Nebules are for inhalation use only. They should be administered as an aerosol produced by a jet nebuliser, as directed by a physician. As drug delivery from nebulisers is variable, the manufacturer’s instructions for using the nebuliser must be followed.
Use of Flixotide Nebules with ultrasonic nebulisers is not generally recommended.
Flixotide Nebules should not be injected or administered orally.
Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly. It is advisable to administer Flixotide Nebules via a mouthpiece to avoid the possibility of atrophic changes to facial skin which may occur with prolonged use with a face-mask. When a face-mask is used, the exposed skin should be protected using a barrier cream, or the face should be thoroughly washed after treatment.
In adults and adolescents over 16 years Flixotide Nebules can be used: For prophylactic management of severe chronic asthma in patients requiring high dose inhaled or oral corticosteroid therapy. On introduction of inhaled fluticasone propionate many patients currently treated with oral corticosteroids may be able to reduce significantly, or eliminate, their oral dose.
Children and adolescents from 4 to 16 years of age: Treatment of acute exacerbations of asthma. Subsequent maintenance dosing may be more conveniently accomplished using a pressurised metered dose inhaler or powder formulation. Fluticasone propionate given by inhalation has a potent glucocorticoid antiinflammatory action within the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with other prophylactic therapy. Relatively brief symptomatic episodes can generally be relieved by the use of fast-acting bronchodilators, but longer-lasting exacerbations require, in addition, the use of corticosteroid therapy as soon as possible to control the inflammation.
History of hypersensitivity to any of their components.
The management of asthma should follow a stepwise program, and patient response should be monitored clinically and by lung functions test. Patient inhaler technique should be checked regularly. Flixotide preparations are not designed to relieve acute symptoms, but for routine long term management. Lack of response or severe exacerbations should be treated by increasing the dose and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection. Increasing use of short-acting inhaled Beta 2-agonists to relieve symptoms indicates deterioration of asthma control. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. Height of children receiving prolonged treatment with inhaled corticosteroids should be regularly monitored. The possibility of impaired adrenal response should always be borne in mind. Patients transferring from oral steroid therapy to inhaled fluticasone propionate therapy should be treated with special care, and adrenocortical function regularly monitored. Replacement of systemic steroid treatment with inhaled therapy may sometimes unmask allergies previously controlled by the systemic drug.
Pregnancy and lactation: Administration during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Candidiasis of the mouth and throat, hoarseness. Paradoxical bronchospasm may occur. Rare reports of peripheral edema and cutaneous hypersensitivity reactions, facial and oropharyngeal edema. Very rare reports of dyspepsia and arthralgia. Adrenal suppression, growth retardation, decrease in bone mineral density, cataract and glaucoma.
For full details see prescribing information.
Phenytoin, barbiturates, carbamazepine, aminoglutethimide, rifampicin. Thiazide and loop diuretics, cardiac glycosides, acetazolamide. Oral hypoglycemics, insulin, antihypertensives, anabolic steroids, ophthalmic idoxuridine. NSAIDs, aspirin, other salicylates, coumarin anticoagulants, vaccines, estrogens.
For full details see prescribing information
Pregnancy and Lactation
Pregnancy: There is inadequate evidence of safety of fluticasone propionate in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Because Flixotide Nebules deliver fluticasone propionate directly to the lungs by the inhaled route the high level of exposure that occurs when corticosteroids are given by systemic routes is avoided. 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 fetus.
Lactation: The secretion of fluticasone propionate in human breast milk has not been investigated. Subcutaneous administration of fluticasone propionate to lactating laboratory rats produced measurable plasma levels and evidence of fluticasone propionate in the milk. However, plasma levels in humans after inhalation at recommended doses are likely to be low. When fluticasone propionate is used in breast-feeding mothers the therapeutic benefits must be weighed against the potential hazards to mother and baby.
Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
However if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression may result. Monitoring of adrenal reserve may be necessary. In cases of fluticasone propionate overdose, therapy may still be continued at a suitable dosage for symptom control.
Chronic: risk of adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment with inhaled fluticasone propionate should be continued at a dose sufficient to control asthma.
Treatment: Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.