Fluticasone

Pharmacologic Category

Corticosteroid, Nasal

Dosing: Adult

Allergic rhinitis (fluticasone furoate): Intranasal:

Veramyst (Rx): Initial: Two sprays (27.5 mcg/spray) per nostril once daily (110 mcg/day); once symptoms are controlled, may reduce dosage to 1 spray per nostril once daily (55 mcg/day) for maintenance therapy.

Avamys (Rx) [Canadian product]: Two sprays (27.5 mcg/spray) per nostril once daily (110 mcg/day). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg/day).

Nasal polyps (fluticasone propionate): Intranasal: Xhance (Rx): One spray (93 mcg/spray) per nostril twice daily (372 mcg/day); some patients may require 2 sprays per nostril twice daily (744 mcg/day); maximum dose: 2 sprays per nostril twice daily (744 mcg/day).

Nonallergic rhinitis (fluticasone propionate): Intranasal: Flonase (Rx): Initial: Two sprays (50 mcg/spray) per nostril once daily (200 mcg/day); alternatively, the same total daily dosage may be divided and given as 1 spray per nostril twice daily (200 mcg/day). After the first few days, dosage may be reduced to 1 spray per nostril once daily for maintenance therapy (100 mcg/day) (maximum: 2 sprays in each nostril [200 mcg]/day).

Upper respiratory allergies (OTC): Intranasal:

ClariSpray, Flonase Allergy Relief, Good Sense Nasoflow (fluticasone propionate): Initial: Two sprays (50 mcg/spray) per nostril once daily (200 mcg/day); after 1 week, may adjust to 1 or 2 sprays per nostril once daily (100 to 200 mcg/day). Do not use for more than 6 months unless instructed by health care provider.

Flonase Sensimist (fluticasone furoate): Initial: Two sprays (27.5 mcg/spray) per nostril once daily (110 mcg/day); after 1 week, may adjust to 1 or 2 sprays per nostril once daily (55 to 110 mcg/day). Do not use for more than 6 months unless instructed by healthcare provider.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

Xhance: There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment is likely not necessary. Following nasal administration, bioavailability and renal elimination are minimal.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use caution in moderate to severe impairment due to extensive hepatic metabolism.

Dosing: Pediatric

Note: Product formulations are not interchangeable; use extra caution to ensure proper salt form and dose.

Rhinitis, nonallergic: Flonase (fluticasone propionate, 50 mcg/spray): Children ≥4 years and Adolescents: Intranasal: Initial: 1 spray per nostril once daily (total daily dose: 100 mcg/day). If response is inadequate, increase to 2 sprays per nostril once daily (total daily dose: 200 mcg/day). Once symptoms are controlled, reduce dose to 1 spray per nostril once daily (total daily dose: 100 mcg/day). Maximum daily dose: 2 sprays per nostril once daily (total daily dose: 200 mcg/day). Note: For optimal effects, nasal spray should be used at regular intervals.

Rhinitis, allergic (seasonal and perennial):

Fluticasone furoate (27.5 mcg/spray):

Veramyst, Avamys [Canadian product]: Intranasal:

Children 2 to 11 years: Initial: 1 spray per nostril once daily (total daily dose: 55 mcg/day); if response is inadequate, increase to 2 sprays per nostril once daily (total daily dose: 110 mcg/day); once symptoms have been controlled, the dosage may be reduced to 1 spray per nostril once daily (total daily dose: 55 mcg/day). Maximum daily dose: 2 sprays per nostril once daily (total daily dose: 110 mcg/day)

Children ≥12 years and Adolescents: Initial: 2 sprays per nostril once daily (total daily dose: 110 mcg/day); once symptoms are controlled, dosage may be reduced to 1 spray per nostril once daily (total daily dose: 55 mcg/day)

Fluticasone propionate (50 mcg/spray):

Canadian labeling: Flonase (fluticasone propionate 50 mcg/spray): Intranasal:

Children 4 to 11 years: 1 to 2 sprays per nostril once daily (total daily dose: 100 to 200 mcg/day); maximum daily dose: 2 sprays per nostril once daily (total daily dose: 200 mcg/day). Once symptoms are controlled, reduce dose to 1 spray per nostril once daily (total daily dose: 100 mcg/day).

Children ≥12 years and Adolescents ≤17 years: 2 sprays per nostril once daily (total daily dose: 200 mcg/day); patients with severe rhinitis may benefit from 2 sprays in each nostril twice daily (total daily dose: 400 mcg/day); maximum daily dose: 4 sprays per nostril once daily (total daily dose: 400 mcg/day)

Upper respiratory allergies (OTC):

Fluticasone furoate (27.5 mcg/spray) (eg, Flonase Sensimist): Intranasal:

Children 2 to 11 years: 1 spray per nostril once daily (total daily dose: 55 mcg/day)

Children ≥12 years and Adolescents: 2 sprays per nostril once daily (total daily dose: 110 mcg/day) for 1 week; then may adjust to 1 or 2 sprays per nostril once daily (total daily dose range: 55 to 110 mcg/day)

Fluticasone propionate (50 mcg/spray) (eg, Flonase allergy relief, ClariSpray): Intranasal:

Children 4 to 11 years: 1 spray per nostril once daily (total daily dose: 100 mcg/day)

Children ≥12 years and Adolescents: 2 sprays per nostril once daily (total daily dose: 200 mcg/day) for 1 week; then may adjust to 1 or 2 sprays per nostril once daily (total daily dose range: 100 to 200 mcg/day)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.

Dosing: Hepatic Impairment: Pediatric

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.

Use: Labeled Indications

Rx products:

Allergic rhinitis (Veramyst, Avamys [Canadian product], Flonase [Canadian product]): Management of seasonal and perennial allergic rhinitis in adults and children ≥2 years of age (Veramyst, Avamys) and in patients 4 to 17 years of age (Flonase)

Nasal polyps (Xhance): Treatment of nasal polyps in patients ≥18 years of age

Nonallergic rhinitis (Flonase): Management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients ≥4 years of age

OTC products:

Upper respiratory allergies: Relief of hay fever or other upper respiratory allergies (eg, itchy and watery eyes, nasal congestion, runny nose, sneezing, itchy nose) in adults and children ≥4 years of age (Clarispray, Flonase Allergy Relief, Good Sense Nasoflow) or children ≥2 years of age (Flonase Sensimist)

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

​Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment)Level of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults and the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, fluticasone (nasal), among other intranasal corticosteroids, is effective and recommended as an adjunctive treatment to antibiotic therapy for the management of ABRS, primarily when a history of allergic rhinitis exists (according to IDSA guidelines).

​Chronic rhinosinusitisLevel of Evidence [G]

Based on the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, fluticasone (nasal), among other intranasal corticosteroids, is effective and recommended (with or without nasal saline irrigation) for the symptomatic relief of chronic rhinosinusitis.

​Viral rhinosinusitis symptomatic reliefLevel of Evidence [G]

Based on the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, topical intranasal steroids (including fluticasone), analgesics, and/or nasal saline irrigation may be recommended for symptomatic relief of viral rhinosinusitis Ref.

Level of Evidence Definitions

​Level of Evidence Scale

Class and Related Monographs

Intranasal Steroids

Clinical Practice Guidelines

AAAAI and ACAAI, “Treatment of Seasonal Allergic Rhinitis,” 2017 Update

AAO-HNS , “Clinical Practice Guideline (Update): Adult Sinusitis,” 2015

AAO-HNS, “Clinical Practice Guideline: Allergic Rhinitis,” 2015

IDSA, “Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” 2012

Administration: Intranasal

For use in nostril only; do not spray in eyes or mouth. Administer at regular intervals. Shake bottle gently before using. Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. 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.

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.

Veramyst, Avamys [Canadian product]: 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. After each use, nozzle should be wiped with a clean, dry tissue. Once weekly, inside of cap should be cleaned with a clean, dry tissue.

Flonase Sensimist: Shake bottle vigorously before using. Prime pump. Sniff gently after each spray. Wipe spray nozzle after each use with clean, dry tissue and replace cap.

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.

Administration: Pediatric

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, ClariSpray: Prime pump (press 6 times until fine spray appears) prior to first use or if spray unused for ≥7 days.

Flonase Sensimist: Shake bottle vigorously before using. 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.

Veramyst, Avamys [Canadian product]: 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. After each use, nozzle should be wiped with a clean, dry tissue. Once weekly, inside of cap should be cleaned with a clean, dry tissue.

Storage/Stability

ClariSpray, Flonase, Flonase Allergy Relief, Good Sense Nasoflow: Store between 4°C to 30°C (39°F to 86°F).

Veramyst, Flonase Sensimist: Store between 15°C to 30°C (59°F to 86°F); do not refrigerate or freeze. Store Veramyst in upright position with cap on.

Xhance: Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Avoid exposure to extreme heat, cold, or light.

Avamys [Canadian product]: Store between 4°C to 30°C (39°F to 86°F); do not refrigerate or freeze. Store in upright position with cap on.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to ease allergy signs.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Nausea

• Vomiting

• Cough

• Stinging

• Sneezing

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss.

• Severe stuffy nose

• Nasal sores

• Severe nosebleeds

• Wheezing

• Thrush

• Abnormal nasal discharge

• Severe face pain

• Runny nose

• Nasal crusting

• Bone pain

• Chills

• Severe sore throat

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Medication Safety Issues

​Sound-alike/look-alike issues:

​International issues:

Contraindications

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 (Clarispray, Flonase Allergy Relief, Good Sense Nasoflow) 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.

Documentation of allergenic cross-reactivity for intranasal steroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Flonase: Untreated fungal, bacterial, or tuberculosis infections of the respiratory tract

Warnings/Precautions

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 active or quiescent tuberculosis infections 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 you 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.

• Withdrawal: Symptoms of corticosteroid withdrawal (eg, joint pain, muscle pain, lassitude, depression) may occur when transferring from a systemic corticosteroid to a topical corticosteroid.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

No differences in safety have been observed in the elderly when compared to younger patients. Based on current data, no dosage adjustment is needed based on age. Evaluate the patient's or caregiver's ability to safely administer the correct dose of nasal medication.

Warnings: Additional Pediatric Considerations

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.

Pregnancy Considerations

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]).

Breast-Feeding Considerations

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]).

Briggs' Drugs in Pregnancy & Lactation

• Fluticasone

Adverse Reactions

>10%: Central nervous system: Headache (4% to 16%)

1% to 10%:

Central nervous system: Body pain (1% to 3%), dizziness (1% to 3%), generalized ache (1% to 3%)

Endocrine & metabolic: Weight gain (1% to <3%)

Gastrointestinal: Nausea and vomiting (3% to 5%), abdominal pain (1% to 3%), diarrhea (1% to 3%), abdominal distress (1% to <3%), toothache (1% to <3%)

Local: Local irritation (nose: 4% to 6%)

Ophthalmic: Increased intraocular pressure (1% to <3%)

Respiratory: Epistaxis (6% to 12%), nasal mucosa ulcer (3% to 8%; includes nasal septal ulceration), pharyngitis (3% to 8%), nasopharyngitis (8%), acute asthma (7%), nasal congestion (6%), acute sinusitis (5%), cough (4%), blood in nasal mucosa (1% to 3%), bronchitis (1% to 3%), flu-like symptoms (1% to 3%), rhinorrhea (1% to 3%), dry nose (1% to <3%), oropharyngeal pain (1% to <3%), sinusitis (1% to <3%)

Miscellaneous: Fever (1% to 3%)

<1%, postmarketing, and/or case reports: Altered sense of smell, anaphylactoid reaction, anaphylaxis, angioedema, blurred vision, bronchospasm, cataract, conjunctivitis, contact dermatitis, dry eye syndrome, dry throat, dysgeusia, dyspnea, esophageal candidiasis, eye irritation, facial edema, glaucoma, growth suppression, hoarseness, hypersensitivity reaction, intestinal candidiasis, nasal candidiasis, nasal septum perforation, pharyngeal candidiasis, pruritus, skin rash, sore throat, throat irritation, tongue edema, urticaria, voice disorder, wheezing

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Corticosteroid Allergy

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions Open Interactions

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Nasal). Risk X: Avoid combination

Desmopressin: Corticosteroids (Nasal) may enhance the hyponatremic effect of Desmopressin. 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

Monitoring Parameters

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

Advanced Practitioners Physical Assessment/Monitoring

Monitor growth with long-term use in pediatric patients. Assess for signs and symptoms of HPA axis suppression/adrenal insufficiency. Assess for ocular changes. Assess for signs of nasal ulceration or septal perforation. Assess for sign and symptoms of Candida infection with long-term use.

Nursing Physical Assessment/Monitoring

Instruct patient on proper administration. Educate patient regarding risk for developing nasal ulcerations, epistaxis, or discomfort.

Dosage Forms Considerations

Flonase 16 g bottles and Veramyst 10 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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

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, 6.6 mL, 9.1 mL) [contains benzalkonium chloride, edetate disodium, polysorbate 80]

Veramyst: 27.5 mcg/spray (10 g [DSC]) [contains benzalkonium chloride]

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]

GoodSense Nasoflow: 50 mcg/actuation (15.8 mL [DSC]) [contains alcohol, usp, benzalkonium chloride, polysorbate 80]

Generic: 50 mcg/actuation (16 g, 9.9 mL, 15.8 mL)

Therapy Pack, Nasal, as propionate:

Ticaspray: 50 mcg/actuation (1 ea [DSC]) [contains benzalkonium chloride, polysorbate 80]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Nasal, as furoate:

Avamys: 27.5 mcg/spray (10 g) [contains benzalkonium chloride, edetate disodium, polysorbate 80]

Suspension, Nasal, as propionate:

Flonase: 50 mcg/actuation ([DSC]) [contains benzalkonium chloride, polysorbate 80]

Generic: 50 mcg/actuation (6 g, 16 g)

Anatomic Therapeutic Chemical (ATC) Classification

• R01AD08

Generic Available (US)

May be product dependent

Pricing: US

Exhaler Suspension (Xhance Nasal)

93 mcg/ACT (per mL): $38.60

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): $4.70 - $5.33

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.

Mechanism of Action

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

Pharmacodynamics/Kinetics

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)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Accumulation of fluticasone in plasma may occur in patients with hepatic impairment.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Pharmacotherapy Pearls

Effects of intranasal steroids on growth have been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The product labeling notes that intranasal administration was not associated with a statistically-significant reduction in growth velocity (based on a small study conducted over 1 year).

When used short term as adjunctive therapy in acute bacterial rhinosinusitis (ABRS), intranasal steroids show modest symptomatic improvement and few adverse effects, primarily due to increased sinus drainage. Use should be considered optional in ABRS; however, intranasal corticosteroids should be prescribed to ABRS patients who have a history of or concurrent allergic rhinitis.

Index Terms

ClariSpray; Flonase Sensimist; Fluticasone Furoate; Fluticasone Propionate

FDA Approval Date

October 19, 1994

References

Alhussien AH, Alhedaithy RA, Alsaleh SA. Safety of intranasal corticosteroid sprays during pregnancy: an updated review. Eur Arch Otorhinolaryngol. 2018;275(2):325-333. doi:10.1007/s00405-017-4785-3[PubMed 29164323]

Avamys (fluticasone) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; November 2018.

Battista MC, Boutin M, Venne P, et al. Maternal inhaled fluticasone propionate intake during pregnancy is detected in neonatal cord blood. Bioanalysis. 2016 Jun 28. [Epub ahead of print][PubMed 27349687]

Children's Flonase Allergy Relief (fluticasone) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; received September 2017.

Chow AW, Benninger MS, Brook I, et al, “IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” Clin Infect Dis, 2012, 54(8):e72-112.[PubMed 22438350]

ClariSpray (fluticasone propionate) [prescribing information]. Morristown, NJ: Bayer; May 2016.[PubMed 22438350]

ClariSpray (fluticasone propionate) [prescribing information]. Morristown, NJ: Bayer; September 2018.[PubMed 22438350]

Flonase (fluticasone) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; January 2019.

Flonase Allergy Relief (fluticasone) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; received June 2020.

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Flonase Sensimist (fluticasone) [prescribing information]. Warren, NJ; GlaxoSmithKline; July 2016.

Flonase Sensimist (fluticasone) [prescribing information]. Warren, NJ; GlaxoSmithKline; November 2018

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Brand Names: International

Alenys (AR); Alisade (EE, MT); Allegro (IL); Allermist (JP); Avamys (AE, AT, AU, BE, BH, BR, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, ET, FR, GB, GR, GT, HK, HN, HR, ID, IE, IL, IS, IT, JO, KR, KW, LB, LK, LT, LU, LV, MT, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, SV, TH, TR, TW, UY, VN, ZW); Avaspray (BD); Clefan (MY); Dalmam AQ (HK); Flixonas (PK); Flixonase (AR, AT, AU, BE, BG, BH, BR, CL, CN, CY, CZ, DK, DO, EC, EE, EG, ES, FI, FR, GB, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JM, JO, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NL, NZ, PA, PE, PH, PL, PY, QA, RO, RU, SA, SG, SI, SK, SV, TH, TR, TT, TW, UY, VE, VN); Flixonase Nasule (IL); Flomist (MY, ZW); Flusort (PH); Flutaide (PT); Flutica (BD, DE); Fluticone (LK); Flutide (NO, SE); Flutimate (MY); Flutinasal (GR); Flutinase (CH); Flutinide (MY); Flutitrim (SG); Lutisone (HK); Nasofan (HK); Nasoflo (PH); Novex (CO); Perinase (BD)

Last Updated 10/10/20