Fluticasone Propionate (Flonase Allergy Relief)

1. Health Canada Product Monograph — Fluticasone Propionate

• Used to relieve nasal symptoms of seasonal allergic rhinitis, including hay fever.
• Used to relieve nasal symptoms of perennial (year-round) allergic rhinitis.
• Used to help manage sinus pain and pressure symptoms associated with allergic rhinitis.

• The safety of fluticasone propionate during pregnancy has not been established.
• If used, the expected benefit should be weighed against the potential risk to the fetus, particularly during the first trimester; the drug has shown teratogenic effects in animal studies, but only at systemic exposure levels much higher than those produced by the low absorption from nasal use.

• It is not known whether fluticasone propionate passes into human breast milk, though other glucocorticoids are known to do so, and it was not detected in milk in animal studies after intranasal-equivalent dosing.
• Use while nursing should weigh the possible benefit to the mother against any potential risk to the infant.

• Only a limited number of patients 65 years and older were studied, but the adverse events reported in this group were similar to those seen in younger patients.
• No dosage adjustment is required based on age alone, though a distinct indication for geriatric use has not been separately authorized.

• Safety and efficacy have not been established in patients younger than 18, so this product is not recommended and is not authorized for use in children or adolescents under 18 years of age.

• The usual adult (18 years and older) dose is two sprays (50 mcg each) in each nostril once daily, for a total daily dose of 200 mcg.
• Once symptoms are controlled, typically after about a week, the dose can often be reduced to one spray in each nostril once daily.
• If symptoms do not improve after 7 days of use, stop and consult a doctor, since another condition such as an infection may be responsible.
• This product should not be used continuously for more than three weeks without symptom improvement, and a doctor should be consulted before continuing use beyond three months.
• If a dose is missed, take the next dose at its regular scheduled time rather than doubling up.

• A burning sensation inside the nose may occur.
• Sore throat (pharyngitis) may occur.
• A runny nose may occur.
• Streaks of blood in nasal mucus may occur.
• Nosebleed (epistaxis) may occur.
• Sneezing may occur.
• Crusting inside the nostrils may occur.
• Nasal congestion may occur.
• A small sore (ulcer) inside the nose may occur.
• Headache may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Nasal septal perforation, a hole forming in the wall between the nostrils, has been reported with prolonged use.
• A fungal infection of the nose or throat with Candida albicans can develop and may require stopping the spray and treating the infection.
• Impaired wound healing in the nose can occur, so the spray should be avoided after recent nasal surgery, trauma, or ulcers until healing is complete.
• With higher-than-recommended or prolonged use, systemic corticosteroid effects such as Cushing's syndrome and suppression of the body's normal cortisol production can occur.
• Eye problems such as glaucoma, cataracts, or increased eye pressure have rarely been associated with nasal corticosteroids.
• Serious allergic reactions, including swelling of the face or tongue, hives, wheezing, difficulty breathing, or anaphylaxis, can occur and require immediate discontinuation.
• Very rare cases of bone death (osteonecrosis) have been reported, mainly in patients with prior or concurrent use of systemic corticosteroids.
• In children, reduced growth velocity has been observed with intranasal corticosteroids as a class, which is part of why this product is not recommended for use under 18.

• Use with caution in patients with untreated tuberculosis or other active respiratory infections, or with quiescent tuberculosis.
• Use with caution in patients taking acetylsalicylic acid (Aspirin), since corticosteroids combined with Aspirin can increase the risk of bleeding-related problems in susceptible patients.
• Use with caution in patients with liver impairment or cirrhosis, since drug clearance may be reduced and corticosteroid effects enhanced.
• Use with caution in patients with hypothyroidism, since corticosteroid effects can be enhanced in this setting.
• Use with caution in patients with asthma, since a rapid reduction in systemic steroids after starting this nasal spray can trigger a severe flare of asthma symptoms.
• Patients switching from long-term systemic corticosteroid therapy should be monitored closely, as this switch can be accompanied by withdrawal symptoms or, rarely, adrenal insufficiency.

• Contraindicated in patients with hypersensitivity to fluticasone propionate or to any other ingredient in the formulation.
• Contraindicated in patients with untreated fungal, bacterial, or tuberculosis infections of the respiratory tract.

• Fluticasone propionate is broken down mainly by the liver enzyme CYP3A4, and ritonavir, a potent inhibitor of this enzyme, can substantially raise fluticasone propionate blood levels and has been linked to Cushing's syndrome and adrenal suppression when combined; this combination should generally be avoided.
• Other CYP3A4 inhibitors such as ketoconazole can also increase systemic exposure to fluticasone propionate, so caution is advised with concurrent use, while erythromycin has only a negligible effect.
• Acetylsalicylic acid (Aspirin) should be used cautiously together with this corticosteroid in patients with a tendency toward abnormal blood clotting (hypothrombinemia).

• No food interactions are established for this nasal spray, since it acts mainly in the nose and reaches the bloodstream only in very small amounts.

• Administered intranasally once daily, at any time of day; full symptom relief typically develops over two to three days of regular use, and starting treatment before allergen exposure season begins can improve control.

• Store between 4 and 30 degrees C.
• Shake the bottle gently before each use.

• Flonase Allergy Relief is an over-the-counter nasal corticosteroid spray used once daily to relieve nasal allergy symptoms and related sinus pressure in adults and adolescents 18 and older.
• The usual dose is two sprays in each nostril once daily, which can often be reduced to one spray per nostril once daily after your symptoms are controlled.
• Common effects include nasal burning, dryness, occasional nosebleeds, sneezing, and headache.
• Contact your doctor's office if symptoms have not improved after 7 days, or if you develop ongoing or severe nosebleeds, nasal pain, vision changes, or signs of an allergic reaction such as facial swelling, hives, or difficulty breathing.
• Prime the spray before first use, aim slightly away from the nasal septum, the wall between the nostrils, while spraying, and avoid using it for more than three weeks without medical advice if symptoms have not improved.
• Store the bottle at room temperature and shake gently before each use.