Fluvent^®

Fluvent^® nasal spray is an aqueous suspension of micronised Fluticasone Propionate for topical administration to nasal mucosa by means of a metering atomizing spray pump. Fluticasone Propionate is a synthetic corticosteroid which is a glucocorticoid receptor agonist with mainly potent anti-inflammatory activity.

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Fluvent^® nasal spray is indicated for the prophylaxis & treatment of seasonal allergic rhinitis (including hay fever) and perennial rhinitis in adult and paediatric patients 4 years of age and older. It has potent anti-inflammatory activity on the nasal mucosa without detectable systemic activity. It is also indicated to prevent the reoccurrence of nasal polyps following surgical removal.

Adults & children over 12 years of age: The starting dose is two sprays (100 micrograms) in each nostril once daily, preferably in the morning, increased to maximum twice daily if required.Once symptoms are under control, reduce to one spray (50 micrograms) into each nostril once daily.

Children 4 to 11 years of age: One spray (50 micrograms) into each nostril once daily preferably in the morning, increased to maximum twice daily if required. The maximum daily dose should not exceed two sprays in each nostril.

Pregnancy category C.There are no adequate & well controlled studies in pregnant women. Fluticasone Propionate should be used during pregnancy, if the potential benefit justifies the potential risks to fetus.
It is not known whether Fluticasone Propionate is excreted in breast milk.As other corticosteroids are excreted in human milk, caution should be exercised when Fluticasone Propionate nasal spray is administered to a lactating mother.

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Intranasal corticosteroids may cause a reduction in growth velocity when adminis­tered to pediatric patients. Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of Fluticasone Propionate nasal spray. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone propionate. Although systemic effects have been minimal with recommended doses of Fluticasone Propionate nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Propionate should be avoided.

The most common side effects reported are nasal irritation & stinging. Rare instances of nasal septum perforation have been reported following intranasal administration. As with other nasal sprays, dryness of nose and throat, unpleasant taste & smell and epistaxis have been reported rarely.

Fluticasone Propionate is contraindicated in those patients with a known history of hypersensitivity to any of the components of the preparation.

Fluticasone Propionate is a substrate of cytochrome P450 3A4. Caution should be exercised when co-administrating known strong cytochrome P450 3A4 inhibitors (e.g. Ketoconazole, Ritonavir) as there is potential for increased systemic exposure to Fluticasone Propionate.

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Store in a cool & dry place protected from light. Keep away from the reach of children.

Fluvent^® nasal spray: Each actuation delivers Fluticasone Propionate BP 50 micrograms.

Fluvent^® nasal spray : Each container contains Fluticasone Propionate BP for 120 metered sprays.