Fluticasone propionate (FLUTIAIR) Nasal Spray 500 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering atomizing spray pump.
It is necessary to prime the pump before first use or after a period of non-use (1 week or more). After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each bottle contains a net fill of 10 mL and will provide 100 actuations.
The correct amount of medication in each spray cannot be assured after 100 sprays even though the bottle is completely empty. The bottle should be discarded when the labeled number of actuations has been used.
Each mL contains Fluticasone Propionate 500 mcg.
Excipients/Inactive Ingredients: Preservatives: Benzalkonium Chloride Solution 0.02% w/v; Phenylethyl Alcohol 0.25% w/v; Purified Water q.s..
Pharmacology: Pharmacodynamics: Mechanism of Action: Fluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity.
Fluticasone propionate was 3-fold to 5-fold more potent than dexamethasone in these assays.
Pharmacokinetics: Fluticasone propionate is poorly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism; oral bioavailability is reported to be only about 1%.
Fluticasone propionate is indicated for the management of nasal symptoms of seasonal and perennial allergic and non-allergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness in children below 4 years of age have not been adequately established.
Fluticasone propionate (FLUTIAIR) is for administration by intranasal route only.
Adults and children over 12 years of age for the prevention and treatment of seasonal allergic rhinitis (including hayfever) and perennial allergic rhinitis: Two sprays into each nostril once a day, preferably in the morning. The maximum daily dose should not exceed two sprays into each nostril.
Children 4-12 years of age for the prevention and treatment of seasonal allergic rhinitis (including hayfever) and perennial allergic rhinitis: One spray into each nostril once a day, preferably in the morning. The maximum daily dose should not exceed two sprays into each nostril.
Maintenance Dose: 1 spray in each nostril once a day.
Not recommended for use in Children below 4 years.
ELDERLY: The normal adult dosage is applicable.
For full therapeutic benefit regular use is essential. The absence of an immediate effect should be explained to the patient as maximum relief may not be obtained until 3 to 4 days of treatment. Do not use continuously for more than 6 months without consulting doctor.
Chronic overdose may result in signs/symptoms of hypercorticism, intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days to healthy human volunteers was well tolerated.
In signs/symptoms of hypercorticism, intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days to healthy human volunteers was well tolerated.
Contraindicated in the patients with hypersensitivity to any of its ingredients.
The replacement of a systemic corticosteroid with topical corticosteroids can be accompanied by signs of adrenal insufficiency, and in addition, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression.
General: 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 (FLUTIAIR) 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. Larger than recommended doses of Fluticasone Propionate (FLUTIAIR) Nasal Spray should be avoided. When used at higher than recommended doses or in rare individuals at recommended doses, systemic individuals at recommended doses, systemic corticosteroids effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of Fluticasone Propionate (FLUTIAIR) Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral corticosteroid therapy.
Patient using Fluticasone Propionate (FLUTIAIR) Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Special Precaution: Not for acute attacks. Caution when transferring patients from systemic steroid treatment. Avoid abrupt withdrawal. May unmask underlying eosinophilic conditions eg. Churg Strauss syndrome. Active or quiescent pulmonary TB.
Pregnancy. Monitor height of children for long-term treatment.
Use with caution during pregnancy.
Co-administration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. Person/Patient who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids.
SHAKE WELL BEFORE USE. FOR INTRANASAL USE ONLY.
Store at a temperature not exceeding 30°C. Protect from light. Do not freeze.
Shelf-life: 24 months.
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Flutiair nasal spray 500 mcg/mL
10 mL x 1's
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