Version May 2024
Dosage guidance:
Clinical considerations: For patients with mucous crusting, rinsing with saline nasal spray before fluticasone administration can remove mucous crusting and improve nasal coating (deShazo 2021). If nasal obstruction is so severe that sprays cannot penetrate, consider concomitant use of an intranasal decongestant for up to 5 days (AAAAI/ACAAI [Dykewicz 2020]).
Allergic rhinitis:
Note: May be used as monotherapy or as part of an appropriate combination regimen. Scheduled administration is more efficacious and generally recommended (AAAAI/ACAAI [Dykewicz 2017]). However, for mild or episodic symptoms, may administer as needed (deShazo 2021).
Fluticasone furoate (27.5 mcg/spray): Intranasal: Initial: 2 sprays in each nostril once daily, scheduled or as needed; if symptoms are controlled after 1 week, consider reducing to 1 spray in each nostril once daily, scheduled or as needed (maximum dose: 2 sprays per nostril per day).
Fluticasone propionate (50 mcg/spray): Intranasal: Initial: 2 sprays in each nostril once daily or 1 spray in each nostril twice daily, scheduled or as needed; if symptoms are controlled after 1 week, consider reducing to 1 spray in each nostril once daily, scheduled or as needed (maximum dose: 2 sprays per nostril per day).
Rhinosinusitis, chronic, with or without nasal polyps:
Note: A 1- to 3-month course of nasal corticosteroids is part of a multimodal approach to initial treatment of chronic rhinosinusitis. Patients with refractory symptoms or significant blockage by polyps may require systemic therapies or surgical intervention (Fokkens 2020; Holbrook 2021). Also used for maintenance therapy after symptom control is achieved.
Fluticasone furoate (27.5 mcg/spray) (off-label use): Intranasal: Initial: 2 sprays in each nostril once daily; once symptoms are controlled, consider reducing to 1 spray in each nostril once daily (maximum dose: 2 sprays per nostril per day) (Venkatesan 2016; manufacturer's labeling).
Fluticasone propionate (50 mcg/spray) (off-label use): Intranasal: Initial: 2 sprays in each nostril once daily or 1 spray in each nostril twice daily; once symptoms are controlled, consider reducing to 1 spray in each nostril once daily (maximum dose: 2 sprays per nostril per day) (Holbrook 2021; manufacturer's labeling).
Fluticasone propionate (93 mcg/spray): Intranasal: 1 spray in each nostril twice daily; some patients may require 2 sprays in each nostril twice daily (maximum dose: 2 sprays in each nostril twice daily).
Nonallergic rhinitis:
Note: May be used as monotherapy or as part of an appropriate combination regimen. Administer scheduled doses on a daily basis regardless of symptoms (Lieberman 2022).
Fluticasone furoate (27.5 mcg/spray) (off-label use): Intranasal: Initial: 2 sprays in each nostril once daily; once symptoms are controlled, consider reducing to 1 spray in each nostril once daily (maximum dose: 2 sprays per nostril per day) (Lieberman 2022; manufacturer's labeling).
Fluticasone propionate (50 mcg/spray): Intranasal: Initial: 2 sprays in each nostril once daily or 1 spray in each nostril twice daily; once symptoms are controlled, consider reducing to 1 spray in each nostril once daily (maximum dose: 2 sprays per nostril per day).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling; use caution in moderate to severe impairment due to extensive hepatic metabolism.
Refer to adult dosing.
(For additional information see "Fluticasone (nasal): Pediatric drug information")
Dosage guidance:
Dosage form information: Product formulations are not interchangeable; use extra caution to ensure proper salt form and dose.
Allergic r hinitis (seasonal and perennial):
Fluticasone furoate (27.5 mcg/spray) (eg, Flonase Sensimist [OTC]; Avamys [Canadian product]):
Children 2 to 11 years: Intranasal: Initial: 1 spray per nostril once daily; dose may be increased, if needed, to 2 sprays per nostril once daily; after improvement of symptoms, decrease dose to 1 spray per nostril once daily. Maximum daily dose: 2 sprays per nostril once daily (total daily dose: 110 mcg/day) (AAO-HNS [Seidman 2015]; Meltzer 2009; Zhang 2021; manufacturer's labeling).
Children ≥12 years and Adolescents: Intranasal: Initial: 2 sprays per nostril once daily; once symptoms are controlled, dosage may be reduced to 1 spray per nostril once daily. Maximum daily dose: 2 sprays per nostril once daily (total daily dose: 110 mcg/day) (AAO-HNS [Seidman 2015]; Given 2010; Han 2011; Jacobs 2009; manufacturer's labeling).
Fluticasone propionate (50 mcg/spray) (eg, Flonase Allergy Relief [OTC]):
Children 4 to 11 years: Intranasal: 1 spray per nostril once daily (total daily dose 100 mcg/day) (AAO-HNS [Seidman 2015]; Grossman 1993; Richards 1996; manufacturer's labeling).
Children ≥12 years and Adolescents: Intranasal: 2 sprays per nostril once daily for 1 week; then may adjust to 1 or 2 sprays per nostril once daily. Maximum dose: 2 sprays per nostril once daily (total daily dose: 200 mcg/day) (Banov 1994; van As 1993; manufacturer's labeling).
Nonallergic r hinitis:
Fluticasone propionate (50 mcg/spray): Children ≥4 years and Adolescents: Intranasal: Initial: 1 spray per nostril once daily. If response is inadequate, increase to 2 sprays per nostril once daily. Once symptoms are controlled, reduce dose to 1 spray per nostril once daily. Maximum daily dose: 2 sprays per nostril once daily (total daily dose: 200 mcg/day) (AAO-HNS [Seidman 2015]; Scadding 1995; Webb 2002; manufacturer's labeling). Note: For optimal effects, nasal spray should be used at regular intervals.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied. Use with caution in patients with severe hepatic impairment; systemic availability of fluticasone may be increased in patients with hepatic impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Nervous system: Headache (4% to 16%)
Respiratory: Epistaxis (6% to 12%)
1% to 10%:
Dermatologic: Localized erythema (nasal mucosal and septal: 4% to 6%)
Endocrine & metabolic: Weight gain (1% to 3%)
Gastrointestinal: Abdominal distress (1% to 3%), abdominal pain (1% to 3%), diarrhea (1% to 3%), nausea and vomiting (3% to 5%), toothache (1% to 3%)
Nervous system: Dizziness (1% to 3%), generalized ache or pain (1% to 3%)
Ophthalmic: Increased intraocular pressure (1% to 3%)
Respiratory: Blood in nasal mucosa (1% to 3%), bronchitis (1% to 3%), cough (4%), dry nose (1% to 3%), flu-like symptoms (1% to 3%), nasal congestion (6%), nasal mucosa ulcer (3% to 8%; includes nasal septal ulceration and nasal erosions), nasopharyngitis (8%), oropharyngeal pain (1% to 3%), pharyngitis (3% to 8%), pulmonary signs and symptoms (asthma symptoms: 7%), rhinorrhea (1% to 3%)
Miscellaneous: Fever (1% to 3%)
<1%:
Gastrointestinal: Esophageal candidiasis, intestinal candidiasis
Respiratory: Nasal candidiasis, nasal septum perforation, pharyngeal candidiasis
Postmarketing:
Cardiovascular: Facial edema
Dermatologic: Pruritus, skin rash, urticaria
Endocrine & metabolic: Growth retardation
Gastrointestinal: Ageusia, dysgeusia, sore throat
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, nonimmune anaphylaxis, tongue edema
Nervous system: Altered sense of smell, anosmia, voice disorder
Ophthalmic: Blurred vision, cataract (including subcapsular posterior cataract), conjunctivitis, dry eye syndrome, eye irritation, glaucoma
Respiratory: Bronchospasm, dry throat, dyspnea, hoarseness, nasal discomfort, throat irritation, wheezing
Hypersensitivity to fluticasone or any component of the formulation
OTC labeling: When used for self-medication, do not use in children <4 years of age (Flonase Allergy Relief) or children <2 years of age (Flonase Sensimist), for the treatment of asthma, or with current injury or surgery to nose that is not fully healed.
Canadian labeling: Additional contraindications (not in US labeling): Flonase: Untreated fungal, bacterial, or tuberculosis infections of the respiratory tract
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Pediatric patients may be more susceptible to systemic toxicity. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Concurrent use of ritonavir (and potentially other strong inhibitors of CYP3A4) may increase fluticasone levels and effects on HPA suppression.
• Delayed wound healing: Avoid use in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.
• Hypersensitivity: Hypersensitivity reactions (including anaphylaxis, angioedema, rash, contact dermatitis, hypotension, bronchospasm, and urticaria) have been reported; discontinue for severe reactions.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox and/or measles should be avoided, especially if not immunized; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.
• Local nasal effects: Nasal septal perforation, nasal ulceration, nasal erosion, epistaxis, and localized Candida albicans infections of the nose and/or pharynx may occur. Monitor patients periodically for adverse nasal effects; discontinuation of therapy may be necessary if an infection occurs; discontinue therapy if nasal septal perforation occurs.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment (accumulation may occur); monitor patients closely.
• Infections: Use caution or avoid use in patients with tuberculosis (TB) infection (latent TB) or disease (active TB) of the respiratory tract, systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. Do not use in untreated localized infection involving the nasal mucosa; concurrent antimicrobial therapy should be administered if bacterial infection of the sinuses is suspected/confirmed.
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in long-term users or in patients who report visual changes.
Special populations:
• Pediatrics: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth). Use for the shortest amount of time necessary to achieve symptom relief.
Other warnings/precautions:
• Appropriate use: Prior to use, the dose and duration of treatment should be based on the risk vs benefit for each individual patient. In general, use the smallest effective dose for the shortest duration of time to minimize adverse events. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing inhalation therapy.
• Self-medication (OTC use): Consult a health care provider before use if taking medicine for HIV infection (eg, ritonavir), steroid for asthma, allergies, or skin rash, or ketoconazole (for a fungal infection). Discontinue use and consult a health care provider if you have come in contact with someone who has chicken pox, measles, or tuberculosis, symptoms do not get better within 7 days or new symptoms occur (eg, severe facial pain, thick nasal discharge), constant whistling sound from nose, changes in vision, or severe or frequent nosebleeds. Stinging or sneezing may occur for a few seconds after use. Consult a health care provider for use longer than 2 months in pediatric patients 4 to 11 years of age; in patients ≥12 years of age, a health care provider should be contacted after 6 months of use.
• Withdrawal: Symptoms of corticosteroid withdrawal (eg, joint pain, muscle pain, lassitude, depression) may occur when transferring from a systemic corticosteroid to a topical corticosteroid.
In a small pediatric study conducted over one year, no statistically significant effect on growth velocity or clinically relevant changes in bone mineral density or HPA axis function were observed in children 3 to 9 years of age receiving fluticasone propionate nasal spray (200 mcg/day; n=56) versus placebo (n=52); effects at higher doses or in susceptible pediatric patients cannot be ruled out.
Flonase 16 g bottles contain 120 sprays each.
Flonase Allergy Relief 9.9 mL bottles contain 60 sprays, and the 15.8 mL bottles contain 120 sprays.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Exhaler Suspension, Nasal, as propionate:
Xhance: 93 mcg/actuation (16 mL) [contains benzalkonium chloride, edetate (edta) disodium dihydrate, polysorbate 80]
Suspension, Nasal, as furoate:
Flonase Sensimist: 27.5 mcg/spray (5.9 mL) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]
Flonase Sensimist: 27.5 mcg/spray (5.9 mL, 6.6 mL, 9.1 mL) [alcohol free; contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]
Suspension, Nasal, as propionate:
Flonase Allergy Relief: 50 mcg/actuation (9.9 mL, 11.1 mL, 15.8 mL, 18.2 mL) [contains benzalkonium chloride, polysorbate 80]
FT Allergy Relief 24 HR: 50 mcg/actuation (11.1 mL) [contains benzalkonium chloride, polysorbate 80]
Generic: 50 mcg/actuation (16 g, 9.9 mL, 15.8 mL)
May be product dependent
Exhaler Suspension (Xhance Nasal)
93 mcg/ACT (per mL): $47.01
Suspension (Flonase Allergy Relief Nasal)
50 mcg/ACT (per mL): $1.44
Suspension (Flonase Sensimist Nasal)
27.5 mcg/spray (per mL): $2.74
Suspension (Fluticasone Propionate Nasal)
50 mcg/ACT (per gram): $5.33 - $11.25
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Nasal, as furoate:
Avamys: 27.5 mcg/spray (10 g) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]
Suspension, Nasal, as propionate:
Generic: 50 mcg/actuation (6 g, 16 g)
Intranasal: For intranasal use only; do not spray in eyes or mouth. Administer at regular intervals. Shake bottle gently before each use. Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright and head tilted downward, and close off the other nostril. Do not spray directly at the septum. Breathe in through nose. While inhaling, press pump to release spray. Discard after labeled number of doses has been used, even if bottle is not completely empty.
Avamys [Canadian product], Flonase Sensimist: Shake bottle vigorously before using. Prime pump (press 6 times until fine spray appears) prior to first use, if spray unused for ≥30 days, or if cap left off bottle for ≥5 days. Sniff gently after each spray. Wipe spray nozzle after each use with clean, dry tissue and replace cap. Once weekly, inside of cap should be cleaned with a clean, dry tissue.
Flonase: Prime pump (press 6 times until fine spray appears) prior to first use or if spray unused for ≥7 days. Once weekly, nasal applicator may be removed and rinsed with warm water to clean.
Xhance: Avoid spraying directly on the septum. Prior to first use, prime pump by gently shaking and press bottle 7 times until fine mist appears; if not used for ≥7 days, re-prime pump again by shaking and releasing 2 sprays into the air. Insert nosepiece deep into one nostril and form a tight seal and then place the flexible mouthpiece into the mouth; blow into the mouthpiece, and while continuing to blow, push the bottle up to actuate the spray pump; continue to blow through the mouth, but do not inhale or exhale through the nose at the time of actuation; repeat in the other nostril for a full dose.
Intranasal: Shake well prior to each use. Blow nose to clear nostrils before each use. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Do not spray into eyes. Discard after labeled number of doses has been used, even if bottle is not completely empty.
Flonase: Prime pump (press 6 times until fine spray appears) prior to first use or if spray unused for ≥7 days.
Flonase Sensimist, Avamys [Canadian Product]: Prime pump (press 6 times until fine spray appears) when using a new bottle, if bottle unused for ≥30 days, if the cap has been left off for ≥5 days, or if the device is not working properly. Wipe spray nozzle after each use with clean, dry tissue and replace cap.
Allergic rhinitis: Management of seasonal and perennial allergic rhinitis in adults and children ≥2 years of age.
Chronic rhinosinusitis with nasal polyps: Treatment of chronic rhinosinusitis with nasal polyps in patients ≥18 years of age. May be used off label for chronic rhinosinusitis without nasal polyps (Fokkens 2020).
Nonallergic rhinitis: Management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients ≥4 years of age.
Flonase may be confused with Flovent
Allegro: Brand name for fluticasone [Israel], but also the brand name for frovatriptan [Germany]
Allegro [Israel] may be confused with Allegra and Allegra-D brand names for fexofenadine and fexofenadine/pseudoephedrine, respectively, [US, Canada, and multiple international markets]
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Fluticasone (Nasal). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Nasal). Risk X: Avoid combination
Esketamine: Corticosteroids (Nasal) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal corticosteroid on an esketamine dosing day should administer the nasal corticosteroid at least 1 hour before esketamine. Risk D: Consider therapy modification
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Nirmatrelvir and Ritonavir: May increase the serum concentration of Fluticasone (Nasal). Management: Use of nasal fluticasone together with a strong CYP3A4 inhibitor is not recommended. Consider an alternative nasal corticosteroid, when possible. Risk D: Consider therapy modification
Fluticasone can be detected in cord blood following maternal use via oral inhalation during pregnancy; one woman in the study was also using intranasal fluticasone (Battista 2016).
Maternal use of intranasal corticosteroids in usual doses are not associated with an increased risk of fetal malformations or preterm birth (ERS/TSANZ [Middleton 2020]). Systemic absorption of fluticasone nasal is limited. Use of intranasal fluticasone is likely acceptable for the treatment of allergic rhinitis during pregnancy (Alhussien 2018; BSACI [Scadding 2017]; ERS/TSANZ [Middleton 2020]).
It is not known if sufficient quantities of fluticasone are absorbed following inhalation to produce detectable amounts in breast milk.
Systemic corticosteroids are present in human milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Use of intranasal fluticasone is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).
Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); ocular changes; signs/symptoms of Candida infection (long-term therapy); hepatic function
Fluticasone belongs to a group of corticosteroids which utilizes a fluorocarbothioate ester linkage at the 17 carbon position; extremely potent vasoconstrictive and anti-inflammatory activity
Onset of action: Maximal benefit may take several days or several months (Xhance)
Distribution: Fluticasone propionate: 4.2 L/kg; Fluticasone furoate: Vd,ss: 608 L
Protein binding: 99%
Metabolism: Hepatic via CYP3A4 to 17 beta-carboxylic acid (negligible activity)
Bioavailability: <2%
Half-life elimination: IV: Fluticasone propionate: ~8 hours (~7.8 hours [Xhance]); Fluticasone furoate: ~15 hours
Excretion: Oral: Feces (as parent drug and metabolites); Urine (<5% as metabolites)
Hepatic function impairment: Accumulation of fluticasone in plasma may occur in patients with hepatic impairment.
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