Metered dose inhaler: 125 & 250 mcg/dose
Indication & Usage
Fluticasone propionate given by inhalation offers prophylactic treatment for asthma.
Mild asthma: Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular daily basis.
Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.
Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. On introduction of inhaled fluticasone propionate many of these patients may be able to reduce significantly, or to eliminate, their requirement for oral corticosteroids.
Any child who requires prophylactic medication, including patients not controlled on currently available prophylactic medication
Dosage & Administration
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 within 4 to 7 days.
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.
Fluticasone propionate inhaler is for oral inhalation use only. Fluticasone propionate inhaler may be used with a spacer device by patients who find it difficult to synchronize aerosol actuation with inspiration of breath.
Adults and children over 16 years:
100 to 1,000 micrograms twice daily, usually as two twice daily inhalations.
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 200 mcg dose of beclomethasone dipropionate (CFC containing) or budesonide. Due to the risk of systemic effects, doses above 500 micrograms twice daily should be prescribed only for adult patients with severe asthma where additional clinical benefit is expected, demonstrated by either an improvement in pulmonary function and/or symptom control, or by a reduction in oral corticosteroid therapy.
Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate to the severity of their disease.
The dose may be increased until control is achieved or reduced to the minimum effective dose, according to the individual response.
Typical Adult Starting Doses:
For patients with mild asthma, a typical starting dose is 100 micrograms twice daily. In moderate and more severe asthma, starting doses may need to be 250 to 500 micrograms twice daily. Where additional clinical benefit is expected, doses of up to 1000 micrograms twice daily may be used.
Initiation of such doses should be prescribed only by a specialist in the management of asthma (such as a consultant physician or general practitioner with appropriate experience).
The dose should be titrated down to the lowest dose at which effective control of asthma is maintained
Typical starting doses for children over 4years of age:
50 to 100 micrograms twice daily.
Many children's asthma will be well controlled using the 50 to 100 micrograms twice daily dosing regimen. For those patients, whose asthma is not sufficiently controlled, additional benefit may be obtained by increasing the dose up to 200 micrograms twice daily.
The maximum licensed dose in children is 200 micrograms twice daily.
Flohale 125 and 250 mcg inhaler are not recommended for children below 16 years of age.
The starting dose should be appropriate to the severity of the disease. The dose should be titrated down to the lowest dose at which effective control of asthma is maintained.
Administration of doses above 1000 micrograms (500 micrograms twice daily) should be via a spacer device to help reduce side-effects in the mouth and throat.
Special patient groups:
There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment.
Use of a spacer device with Flohale inhaler is recommended in patients who have, or are likely to have difficulties to coordinate actuation with inspiration.
Frequencies are defined as:
Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥
1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data) including isolated reports.
Very common: Candidiasis of the mouth and throat.
Common: Pneumonia (in COPD patients), Hoarseness/dysphonia, Contusions.
Uncommon: Cutaneous hypersensitivity reactions.
Rare: Esophageal candidiasis.
Very rare: Angioedema (mainly facial and oropharyngeal edema), Respiratory symptoms (dyspnea and/ or bronchospasm), Anaphylactic reactions, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract, glaucoma, Hyperglycemia, Anxiety, sleep disorders, behavioral changes, including hyperactivity and irritability (predominantly in children), Paradoxical bronchospasm, Dyspepsia, Arthralgia.
Not known: Depression, aggression (predominantly in children), Epistaxis.
Hypersensitivity to the active substance or any of the excipients.
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.
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations. Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. Cases of Cushing's syndrome and adrenal suppression have been reported. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone. Co-treatment with other potent CYP3A inhibitors, such as ltraconazole, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic side-effects. Caution is recommended and long-term treatment with such drugs should, if possible, be avoided.
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.
Warnings & Precautions
The management of asthma should follow a stepwise program, and patient response should be monitored clinically and by lung function tests.
Patients' inhaler technique should be checked regularly to make sure that inhaler actuation is synchronized with inspiration to ensure optimum delivery to the lungs. During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in a vertical position.
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.
Fluticasone propionate inhaler is not designed to relieve acute symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available.
Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death. Increasing use of short-acting inhaled β2-agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way.
There have been very rare reports of increases in blood glucose levels, in patients with or without a history of diabetes mellitus. This should be considered in particular when prescribing to patients with a history of diabetes mellitus.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. Fluticasone propionate inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged 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 behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important therefore that the dose of inhaled corticosteroid is reviewed regularly and reduced to the lowest dose at which effective control of asthma is maintained.
Prolonged treatment with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Children aged < 16 years taking higher than licensed doses of fluticasone (typically ≥ 1000mcg/day) may be at particular risk. Situations, which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, hypoglycemia, and seizures.
Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. 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 pediatric respiratory specialist.
Certain individuals can show greater susceptibility to the effects of inhaled corticosteroid than do most patients.
Administration of high doses, above 1000 mcg daily is recommended through a spacer to reduce side effects in the mouth and throat. However, as systemic absorption is largely through the lungs, the use of a spacer plus metered dose inhaler may increase drug delivery to the lungs. It should be noted that this could potentially lead to an increase in the risk of systemic adverse effects. A lower dose may be required.
The benefits of inhaled fluticasone propionate should minimize the need for oral steroids. However, patients transferred from oral steroids, remain at risk of impaired adrenal reserve for a considerable time after transferring to inhaled fluticasone propionate. The possibility of adverse effects may persist for some time. These patients may require specialized advice to determine the extent of adrenal impairment before elective procedures. The possibility of residual impaired adrenal response should always be considered in emergency (medical or surgical) and elective situations likely to produce stress, and appropriate corticosteroid treatment considered.
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.
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.
As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.
Treatment with fluticasone propionate inhaler should not be stopped abruptly.
Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects. There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors.
Pregnancy & Lactation
There is inadequate evidence of safety of fluticasone propionate in human pregnancy. Data on a limited number (200) of exposed pregnancies indicate no adverse effects of fluticasone propionate inhaler on pregnancy or the health of the fetus/new born child.
Because fluticasone propionate inhaler delivers fluticasone propionate directly to the lungs by the inhaled route it avoids the high level of exposure that occurs when corticosteroids are given by systemic routes.
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.
The secretion of fluticasone propionate in human breast milk has not been investigated.
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.
Do not store above 30°C.
Do not refrigerate or freeze. Protect from frost and direct sunlight.
As with most medicines in pressurized canisters, the therapeutic effect of this medication may decrease when the canister is cold.
The canister should not be punctured, broken or burnt even when apparently empty.
Keep out of reach of children.
Each pack contains 1 inhaler, 120 metered doses each.
Cipla Ltd/ India
Marketing Authorization Holder