Fluvate 120 metered sprays

Each actuation delivered through a atomizing nasal applicator contains 50 µgm of Fluticasone Propionate

Fluticasone Propionate Nasal Spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of this Nasal Spray in children below 4 years of age have not been adequately established.

Fluocinolone & Combined Preparations, Nasal Steroid Preparations

Pharmacology

Fluticasone utilises a fluorocarbothioate ester linkage at the 17 carbon position. It has potent vasoconstrictive and anti-inflammatory activity, but weak hypothalamic-pituitary-adrenal (HPA) inhibitory effect when applied topically.

Adults:

• Recommended usual dosage: 02 sprays (50 µgm/spray) in each nostril once daily, preferably in the morning. In some cases, 02 sprays in each nostril twice daily may be required.
• Total daily doses of 200 µgm (04 sprays) should not generally be exceeded.

Children (4 to 11 years of age):

• Usual dose: 01  spray in each nostril once daily. In some cases, 01 spray in each nostril twice daily may be required.
• Total daily doses of 100 µgm (02 sprays) should not generally be exceeded.

No drug interaction studies have been conducted with Fluticasone Propionate nasal spray; however care should be exercised when this drug is coadministered with long term Ketoconazole and other known cytochrome P 450 inhibitors.

Contraindicated in patients with a history of hypersensitivity to any of its components.

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.

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 is excreted in breast milk. As other corticosteroids are excreted in human milk, caution should be exercised when Fluticasone nasal spray is administered to a lactating mother.

Infection of the nasal airways should be appropriately treated but do not constitute a specific contraindication to treatment with steroids. Care must be taken while transferring patients from systemic steroid to Fluticasone nasal spray if there is any reason to suppose that their adrenal function is impaired. Although Fluticasone nasal spray will control seasonal and perennial 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.

Symptoms: Suppression of adrenal function (inhalation); hypercortisolism (topical).

Management: Gradually reduce the dose.

Store at a temperature not exceeding 30˚C. Protect from light & moisture. Keep out of the reach of children.