Flixonase 50 mcg/metered spray is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomising spray pump.
Pharmacokinetics: Following oral administration, 87-100% of the dose is excreted in the faeces, up to 75% as parent compound depending on the dose. There is one poorly active major metabolite.
Following IV administration, there is rapid plasma clearance suggestive of extensive hepatic extraction. The plasma elimination half-life is approximately 3 hrs. The volume of distribution is approximately 260 L.
Fluticasone propionate causes little or no hypothalamic-pituitary-adrenal (HPA) axis suppression following intranasal or topical (dermal) administration.
For the prophylaxis and treatment of seasonal allergic rhinitis including hay fever and perennial rhinitis. It has potent anti-inflammatory activity but when used topically on the nasal mucosa has no detectable systemic activity.
Flixonase is for administration by the intranasal route only.
Adults and Children >12 years: For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis: 2 sprays into each nostril once a day, preferably in the morning. In some cases, 2 sprays into each nostril twice daily may be required. The maximum daily dose should not exceed 4 sprays into each nostril.
Children <12 years: For the prophylaxis and treatment of seasonal allergic rhinitis: A dose of 1 spray into each nostril once daily is recommended. The maximum daily dose should not exceed 2 sprays into each nostril.
For the prophylaxis and treatment of perennial rhinitis in children, there are insufficient clinical data at present to recommend the use of Flixonase.
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 3-4 days of treatment.
Elderly: The normal adult dosage is applicable.
There are no data available on the effects of acute or chronic overdosage with Flixonase. Intranasal administration of 2 mg fluticasone propionate twice daily for 7 days to healthy human volunteers had no effect on hypothalamo-pituitary-adrenal axis function.
Hypersensitivity to any of the ingredients of Flixonase.
Local Infection: Infections of the nasal airways should be appropriately treated but do not constitute a specific contraindication to treatment with Flixonase.
The full benefit of Flixonase may not be achieved until treatment has been administered for several days.
Care must be taken while transferring patients from systemic steroid treatment to Flixonase, if there is any reason to suppose that their adrenal function is impaired.
Although Flixonase will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances, necessitate appropriate additional therapy, particularly to control eye symptoms.
Use in pregnancy: 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 systemic exposure. However, as with other drugs, the use of Flixonase during human pregnancy requires that the benefits be weighed against the possible risk associated with Flixonase or with any alternative therapy.
Use in lactation: It is not known whether fluticasone propionate is excreted in human breast milk, nor are there any data available from animal studies. However, following intranasal administration to primates, no drug was detected in the plasma, and it is therefore unlikely that the drug would be detectable in milk.
Use in pregnancy: 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 systemic exposure. However, as with other drugs, the use of Flixonase during human pregnancy requires that the benefits be weighed against the possible risk associated with Flixonase or with any alternative therapy.
Use in lactation: It is not known whether fluticasone propionate is excreted in human breast milk, nor are there any data available from animal studies. However, following intranasal administration to primates, no drug was detected in the plasma, and it is therefore unlikely that the drug would be detectable in milk.
No major side effects attributed to Flixonase have been reported. As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.
Store for 2 years below 30°C.
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Flixonase Hỗn dịch xịt mũi 0.05%
60 dose x 1's
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