Flixonase輔舒良

Flixonase

fluticasone

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Fluticasone propionate.
Description
Each 100 mg of spray delivered by the nasal adaptor contains 50 micrograms of fluticasone propionate.
FLIXONASE Aqueous Nasal Spray (0.05% w/w) is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomising spray pump.
Indications/Uses
FLIXONASE Aqueous Nasal Spray is indicated for the prophylaxis and treatment of seasonal allergic rhinitis including hayfever and perennial rhinitis. Fluticasone propionate has potent anti-inflammatory activity but when used topically on the nasal mucosa has no detectable systemic activity.
Dosage/Direction for Use
For full therapeutic benefit regular usage is essential. Clinical relevant improvement in symptoms occurs approximately 12 hours after the initial dose. The absence of an immediate effect should be explained to the patient as maximum relief may not be obtained until after three to four days of treatment.
FLIXONASE Aqueous Nasal Spray is for administration by the intranasal route only.
For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis: Adults and children over 12 years of age: 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. The maximum daily dose should not exceed four sprays into each nostril.
Children aged 4 to 11 years: One spray into each nostril once a day, preferably in the morning. 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.
Elderly: The normal adult dosage is applicable.
Overdosage
There are no data from patients available on the effects of acute or chronic overdosage with intranasal fluticasone propionate. In healthy volunteers, intranasal administration of 2 mg fluticasone propionate twice daily for seven days had no effect on hypothalamic-pituitary-adrenal (HPA) axis function.
Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.
In these patients, treatment with fluticasone propionate should be continued at a dose sufficient to control symptoms; adrenal function will recover in a few days and can be monitored by measuring plasma cortisol.
Contraindications
FLIXONASE Aqueous Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
Special Precautions
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.
Systemic effects with nasal corticosteroids have been reported, 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.
Reduced growth velocity has been observed in children treated with intranasal corticosteroids. Therefore, children should be maintained on the lowest dose which achieves adequate symptom control.
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).
The full benefit of FLIXONASE Aqueous Nasal Spray may not be achieved until treatment has been administered for several days.
Although FLIXONASE 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.
Effects on ability to drive and use machines: Fluticasone propionate is unlikely to produce an effect.
Use In Pregnancy & Lactation
As with other drugs, the use of intranasal fluticasone propionate during pregnancy and lactation requires that the benefits be weighed against possible risks associated with the product or with any alternative therapy.
There is inadequate evidence of safety in human pregnancy. In animal reproduction studies adverse effects typical of potent corticosteroids are only seen at high systemic exposure levels; direct intranasal application ensures minimal systemic exposure.
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 intranasal application of fluticasone propionate at recommended doses are likely to be low.
Adverse Reactions
Adverse events are listed as follows by system organ class and frequency. 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) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account, since these rates were generally comparable to those in the active treatment group.
Immune system disorders: Very rare: Hypersensitivity reactions, anaphylaxis/anaphylactic reactions, bronchospasm, skin rash, oedema of the face or tongue.
Nervous system disorders: Common: Headache, unpleasant taste, unpleasant smell.
As with other nasal sprays, unpleasant taste and smell and headache have been reported.
Eye disorders: Very rare: Glaucoma, raised intraocular pressure, cataract.
A very small number of spontaneous reports have been identified following prolonged treatment. However, clinical trials of up to one year duration have shown that intranasal fluticasone propionate is not associated with an increased incidence of ocular events including cataract, increased intraocular pressure or glaucoma.
Respiratory, thoracic and mediastinal disorders: Very common: Epistaxis.
Common: Nasal dryness, nasal irritation, throat dryness, throat irritation.
As with other intranasal products, dryness and irritation of the nose and throat, and epistaxis have been reported.
Very rare: Nasal septal perforation. Nasal septal perforation has been reported following the use of intranasal corticosteroids.
Drug Interactions
Under normal circumstances, very 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.
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.
Patient Counseling Information
Instructions for Use/Handling: The spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray. A new spray (or one that has not been used for a few days), may not work first time so you will need to prepare the nasal spray following the instructions as follows.
Preparing the nasal spray: You must prepare the nasal spray: Before you use it for the first time.
If you have not used it for a few days.
If you have just cleaned it following the instructions under 'Cleaning the nasal spray'.
Preparing the nasal spray helps to make sure you always get the full dose of medicine. Follow these steps: Shake the nasal spray and remove the dust cap by gently squeezing the ribbed sides with your forefinger and thumb and pulling it straight off. Do not twist it off.
Hold the nasal spray upright and point the nozzle away from you.
Put your forefinger and middle finger on the collar either side of the nozzle and put your thumb underneath the bottle.
Keep your thumb still, and press down firmly on the collar with your fingers to release a fine spray into the air.
The nasal spray is now ready for use.
If you think the nozzle may be blocked, don't use a pin or anything sharp to clear it.
Try to clean it by following the instructions under "Cleaning the nasal spray".
Using the Spray: 1. Shake the nasal spray and remove the dust cap.
2. Blow your nose to clear your nostrils.
3. Close one nostril with your finger and carefully place the nozzle in the other nostril. Tilt your head forward a little bit and hold the nasal spray upright.
4. As you breathe in through your nose, press down firmly on the collar with your fingers.
5. Breathe out through your mouth.
6. Repeat steps 3 to 4 for your other nostril.
7. After using your spray, wipe the nozzle carefully with a clean tissue or handkerchief.
8. Replace the dust cap.
Cleaning the Spray: You must clean your nasal spray at least once a week to stop the nozzle from blocking up. Follow these steps: Remove the dust cap.
Remove the nozzle by pulling upwards on the collar.
Soak the nozzle and dust cap in warm water for a few minutes.
Then rinse under a running tap.
Shake off the excess water and let them dry in a warm place.
Put the nozzle back on the spray.
ATC Classification
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Aqueous nasal spray 0.05% x 150 metered sprays.
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