SQUARE PHARMACEUTICALS LTD.
Fluticasone Furoate nasal spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
Nasal Steroid Preparations
Fluticasone Furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. Like other corticosteroids Fluticasone Furoate is found to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g.- histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
Adults & Children over 12 years: 2 sprays in each nostril once a day. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays. Children under 12 years (2-11 Years): 1 spray in each nostril once a day. Patients should use Fluticasone Furoate nasal spray at regular intervals as directed since its effectiveness depends on its regular use. Children (under 2 years of age): There are no data to recommend use of Fluticasone Furoate Nasal Spray for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age. How to use the Nasal Spray Shake the bottle gently and remove the dust cover. Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine mist comes out from the container. Gently blow the nose to clear the nostrils. Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white collar of nasal applicator firmly down once to release a spray. Breathe out through your mouth. Repeat the above steps in the same/other nostril for consecutive doses.
Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Fluticasone Furoate. Coadministration of ritonavir is not recommended. Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole. Special instruction: Patients should be instructed that the device must be primed: before first use, and if the cap is left off or if the device does not seem to be working or if the nasal spray has not been used for 30 days or more. In order to prime the device, the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen. Once primed, the patient must shake the nasal spray vigorously each time before use.
Fluticasone Furoate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
Eosinophilic conditions, adrenal insufficiency, growth retardation, Cushing's syndrome, decreased bone density, cataract, glaucoma. Rarely, psychological effects.
Pregnancy: Plasma Fluticasone Furoate concentrations were typically non-quantifiable and therefore potential for reproductive toxicity is expected to be very low. Lactation: The excretion of Fluticasone Furoate into human breast milk has not been investigated.
Patients taking Fluticasone Furoate nasal spray should be periodically monitored for signs of adverse effects on the nasal mucosa such as epistaxis, nasal ulceration and impaired wound healing. Avoid using the drug in patients with recent nasal ulcers, nasal surgery, or nasal trauma. Closely monitor patients with a history of increased intraocular pressure, glaucoma and hypersensitivity reactions (including anaphylaxis, angioedema, rash, and urticaria). Besides, potential worsening of existing fungal, bacterial, viral, or parasitic infections or ocular herpes simplex, hypercorticism and growth retardation may occur after the administration of Fluticasone Furoate nasal spray.
Store at a temperature not exceeding 30 8C. Do not refrigerate. Protect from light and moisture. Keep out of the reach of children.