Fluticasone Propionate eentPronunciation
VA Class: NT200
Molecular Formula: C25H31F3O5S
CAS Number: 80474-14-2
Uses for Fluticasone Propionate
Seasonal and Perennial Rhinitis
Symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or is not tolerated.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123
Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing, postnasal drip, and nasal itching;1 2 7 16 19 27 33 34 46 51 55 59 122 123 124 generally does not relieve signs and symptoms of conjunctivitis, although improvement in ophthalmic manifestations may occur.19 62 110 113
Relieves symptoms in both allergic1 2 7 16 19 27 33 34 46 51 54 55 71 73 74 76 78 110 113 122 123 and nonallergic1 57 113 rhinitis, although experience is more extensive with allergic rhinitis.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123
Fluticasone Propionate Dosage and Administration
Avoid contact with the eyes.1
Although regular dosing generally provides optimal benefit, as needed (prn) dosing may be adequate in some patients with seasonal allergic rhinitis.1
Nasal inhaler delivers about 50 mcg of fluticasone propionate per metered spray and about 120 metered sprays per 16-g container.1
Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate.1 6 13 16 27 46 48 51 52 115 This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen.1
Generally assess response to the initial dosage 4–7 days after starting therapy; a reduction in maintenance dosage may be possible at that time.1
Adolescents and children ≥4 years of age: 1 spray (50 mcg) in each nostril once daily (total dose: 100 mcg/day).1 Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.1
Reduce dosage to 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.
Some patients ≥12 years of age with seasonal allergic rhinitis may find as needed (prn) use of 200 mcg (100 mcg in each nostril) doses (no more frequently than once daily) to be effective in controlling symptoms.1 Greater symptom control may be achieved with regular dosing.1
Adolescents and children ≥4 years of age: 1 spray (50 mcg) in each nostril daily (total dose: 100 mcg/day).1 Increase dosage to 2 sprays (100 mcg) in each nostril daily (total dose: 200 mcg/day) if response is inadequate.1
Maintenance dose is 1 spray in each nostril (total dose: 100 mcg/day) once adequate symptom control is achieved.
Some patients with seasonal allergic rhinitis may find as needed (prn) use of 200-mcg (100 mcg in each nostril) doses (no more frequently than once daily) to be effective in controlling symptoms.1 Greater symptom control may be achieved with regular dosing.1
Maintenance dose is 2 sprays (100 mcg) in each nostril daily (200 mcg total).121
Perennial RhinitisIntranasal Inhalation
Usual initial dose is 2 sprays (100 mcg) in each nostril once daily (total dose: 200 mcg/day).1 Alternatively, 1 spray (50 mcg) in each nostril twice daily (total 200 mcg/day).1 16 17 18 19 27 46 51 55
Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing’s syndrome).1
Adolescents and children ≥4 years of age: Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1
Adolescents and children ≥4 years of age: Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1
Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1
Maximum 100 mcg (2 sprays) in each nostril (200 mcg total) daily.1
No specific dosage recommendations for hepatic impairment.1
No specific dosage recommendations for renal impairment.1
No specific geriatric dosage recommendations.1
Cautions for Fluticasone Propionate
Withdrawal of Systemic Corticosteroid Therapy
Patients being switched from prolonged systemic corticosteroids to intranasal therapy should be monitored carefully since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.1 115
Infection, Trauma, or Surgery
Use cautiously, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; ocular herpes simplex infections; or septal ulcers, trauma, or surgery in the nasal region.1
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression
Avoid higher than recommended dosages since suppression of HPA function may occur.1
Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.1 Avoid exposure to varicella and measles in previously unexposed patients.1
Possible immediate hypersensitivity reactions (e.g., wheezing, contact dermatitis, rash, dyspnea, anaphylaxis/anaphylactoid reactions, pruritus, urticaria, angioedema, edema of the face and tongue, and bronchospasm).1 112
Systemic Corticosteroid Effects
Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., Cushing’s syndrome, adrenal suppression).1
Temporary or permanent loss of smell may occur.1
Avoid use until healing occurs in patients with recurrent epistaxis, recent nasal septal ulcers, nasal surgery, or nasal trauma.1
Possible increased IOP.1
Temporary or permanent loss of taste may occur.1
May cause adverse effects (e.g., growth suppression) in nursing infants if distributed into milk.1
May be a useful therapeutic alternative to oral corticosteroids in children ≥4 years of age with seasonal or perennial allergic rhinitis since intranasal administration is associated with a decreased risk of adverse systemic effects.
Intranasal corticosteroids may reduce growth velocity in pediatric patients.1 Children 3–9 years of age receiving 200 mcg of fluticasone propionate daily for 1 year did not show evidence of reduction in normal growth velocity.1 No clinically relevant changes in HPA axis or bone mineral density (as assessed by dual X-ray absorptiometry) observed.1
Adverse effect profile similar to profile in younger adults.1
Common Adverse Effects
Mild, transient nasal burning and stinging,1 3 16 17 21 27 46 51 54 55 aftertaste1 , epistaxis,13 16 17 19 21 22 46 51 54 55 112 124 headache,1 112 124 nausea and vomiting,1 21 abdominal bloating,1 pharyngitis,1 16 17 27 112 cough1 124 and asthma symptoms1 124 are most common.
Interactions for Fluticasone Propionate
Metabolized by CYP3A4.
Drugs Affecting Hepatic Microsomal Enzymes
Potential pharmacodynamic interaction (increased the risk of hypercorticism, suppression of the HPA axis, decreased growth rate in children) with concomitant use of other inhaled and/or systemically absorbed corticosteroids1 38 79 84
Concomitant use not recommended
Does not affect the pharmacokinetics of fluticasone1
Possible increase in mean plasma fluticasone concentrations and toxicity1
Increases plasma fluticasone concentrations, resulting in decreased plasma cortisol AUC1
Cushing’s syndrome and adrenal suppression reported1
Concomitant use not recommended unless potential benefit outweighs the risk of adverse effects1
Fluticasone Propionate Pharmacokinetics
Placental distribution in humans is unknown, but fluticasone crosses the placenta in animals.1
Distribution into milk unknown, but other corticosteroids are distributed.1
Plasma Protein Binding
Discard the nasal pump spray after 120 sprays.1
Reduces the number of mediator cells (basophils,2 5 7 13 17 27 35 46 51 55 57 58 eosinophils,2 4 5 7 9 13 17 27 35 46 50 51 55 57 58 60 61 63 116 helper-inducer [CD4+, T4+] T-cells,4 60 116 mast cells,7 50 60 61 116 and neutrophils)2 7 13 35 in the nasal mucosa. Also reduces nasal reactivity to allergens and release of inflammatory mediators63 and proteolytic enzymes.63
Advice to Patients
Proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.1
Importance of not administering the entire dose (i.e., 2–4 sprays) into a single nostril.1
Give patients a copy of the manufacturer’s patient instructions.1
Importance of shaking containers of nasal spray gently prior to each use.b
Importance of taking as directed and not exceeding prescribed dosage.1
Importance of informing clinician if symptoms fail to improve or if symptoms worsen.1
Importance of not increasing dosage unless directed by a clinician.1
Importance of advising clinician if sneezing or nasal irritation occurs.1
Advise that concomitant nasal decongestants and/or oral antihistamines may be needed until effects of fluticasone are optimal.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Suspension, for intranasal use only
50 mcg/metered spray
Flonase Nasal Spray (with benzalkonium chloride and phenylethyl alcohol)
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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