Flixonase Aqueous Nasal Spray

/ GSK

Adults and children over 12 years of age: For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis. Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice daily may be required. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose should be used at which effective control of symptoms is maintained. The maximum daily dose should not exceed four sprays into each nostril.
Children aged 4 to 11 years: For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis in children aged 4-11 years a dose of one spray into each nostril once daily preferably in the morning is recommended. In some cases one spray into each nostril twice daily may be required. The maximum daily dose should not exceed two sprays into each nostril. The minimum dose should be used at which effective control of symptoms is maintained.
Flixonase Aqueous Nasal Spray should not be prescribed for children for a
period of more than 1 month.
For full therapeutic benefit regular usage is essential. The absence of an
immediate effect should be explained to the patient, as maximum relief may
not be obtained until after 3 to 4 days of treatment.
Elderly: The normal adult dosage is applicable.

Prophylaxis and treatment of seasonal allergic rhinitis including hayfever and perennial rhinitis.

Hypersensitivity to fluticasone propionate or any other of the ingredients.

Treatment should be stopped or the advice of a doctor sought if an improvement is not seen within 7 days. The advice of a doctor or pharmacist should also be sought if symptoms have improved but are not adequately controlled.
This medicine should not be used for more than 3 months continuously without consulting a doctor.
Although fluticasone propionate aqueous nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy.
Medical advice should be sought before using this medicine in the case of:
– concomitant use of other corticosteroid products, such as tablets, creams,
ointments, asthma medications, similar nasal sprays or eye/nose drops.
– fever or an infection in the nasal passages or sinuses.
– recent injury or surgery to the nose, or problems with ulceration in the nose.
Local infection: infections of the nasal airways should be appropriately treated but do not constitute a specific contraindication to treatment with intranasal fluticasone propionate.
Care must be taken when withdrawing patients from systemic steroid treatment, and commencing therapy with intranasal fluticasone propionate, particularly if there is any reason to suspect that their adrenal function is impaired.
Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Significant interactions between fluticasone propionate and potent inhibitors of the cytochrome P450 3A4 system, e.g. ketoconazole and protease inhibitors, such as ritonavir and cobicistat, may occur. This may result in increased systemic exposure to fluticasone propionate.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Flixonase Aqueous Nasal Spray contains benzalkonium chloride which may cause bronchospasm.

Very common: Epistaxis.
Common: Headache, unpleasant taste, unpleasant smell, nasal dryness, nasal irritation, throat dryness, throat irritation.
See prescribing information for full details.

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after intranasal 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.
Co-treatment with other potent CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side- effects, in which case patients should be monitored for systemic corticosteroid side- effects.
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. 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.
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. Care is advised when coadministering cytochrome P450 3A4 inhibitors, especially in long-term use and in case of potent inhibitors, as there is potential for increased systemic exposure to fluticasone propionate.

Pregnancy: There is inadequate evidence of the safety of fluticasone propionate in human pregnancy. As with other drugs the use of this medicine during human pregnancy requires that the possible benefits of the drug be weighed against the possible hazards.
Lactation: The secretion of fluticasone propionate in human breast milk has not been investigated. When this medicine is used in breast feeding mothers the therapeutic benefits must be weighed against the potential hazards to mother and baby.
The label will include a warning that medical opinion should be sought, before using this medicine, in the case of pregnancy or breast feeding.
See prescribing information for full details.

Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.
There are no data available on the effects of acute or chronic overdosage with this medicine. Intranasal administration of fluticasone propionate at 20 times the recommended starting dose in adults (2mg twice daily) for seven days to healthy human volunteers had no effect on hypothalamic-pituitary-adrenal axis function.