Fluticasone (Nasal) (Lexi-Drugs)

Pronunciation

(floo TIK a sone)

Brand Names: US

Flonase Allergy Relief [OTC]; Flonase Sensimist [OTC]; GoodSense Nasoflow [OTC] [DSC]; Ticaspray; Veramyst [DSC]; Xhance

Brand Names: Canada

APO-Fluticasone; Avamys; Flonase [DSC]; RATIO-Fluticasone; TEVA-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.

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 nostrilonce 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)

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)

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
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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, cough, stinging, or sneezing. Have patient report immediately to prescriber signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), severe rhinitis, nasal sores, severe nosebleeds, wheezing, thrush, abnormal nasal discharge, severe face pain, rhinorrhea, nasal crusting, bone pain, chills, severe pharyngitis, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.

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). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.

Intranasal corticosteroids, including fluticasone, may be acceptable for the treatment of rhinitis during pregnancy when used at recommended doses (Lal 2016; Wallace 2008). Pregnant females adequately controlled on fluticasone may continue therapy; if initiating treatment during pregnancy, use of an agent with more data during pregnancy may be preferred (Namazy 2016; Wallace 2008).

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.

Briggs’ Drugs in Pregnancy & Lactation
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

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

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

Drug 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

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Risk C: Monitor therapy

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 disodium dihydrate, polysorbate 80]

Suspension, Nasal, as furoate:

Flonase Sensimist: 27.5 mcg/spray (5.9 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, 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) [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 (10gm) [contains BENZALKONIUM CHLORIDE, EDETATE DISODIUM, POLYSORBATE 80]

Suspension, Nasal, as propionate:

Flonase: 50 mcg/actuation (9gm[DSC], 16gm[DSC]) [contains BENZALKONIUM CHLORIDE, POLYSORBATE 80]

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

Anatomic Therapeutic Chemical (ATC) Classification
  • R01AD08
Generic Available (US)

May be product dependent

Pricing: US

Exhaler Suspension (Xhance Nasal)

93 mcg/ACT (per mL): $35.11

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

Therapy Pack (Ticaspray Nasal)

50MCG/ACT 0.9% (per each): $3,783.22

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

Index Terms

ClariSpray; Flonase Sensimist; Fluticasone Furoate; Fluticasone Propionate

FDA Approval Date
October 19, 1994
References

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]

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]

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

Flonase Allergy Relief (fluticasone) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; received January 2018.

Flonase (fluticasone) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; August 2016.

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

Good Sense Nasoflow (fluticasone propionate) [prescribing information]. Allegan, MI: L. Perrigo Co; June 2016.[PubMed 22438350]

Lal D, Jategaonkar AA, Borish L, et al. Management of rhinosinusitis during pregnancy: systematic review and expert panel recommendations. Rhinology. 2016;54(2):99-104.[PubMed 26800862]

Namazy J, Schatz M. The treatment of allergic respiratory disease during pregnancy. J Investig Allergol Clin Immunol. 2016;26(1):1-7.[PubMed 27012010]

Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 Suppl):S1-S39.[PubMed 25832968]

Veramyst (fluticasone) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; July 2016.

Wallace DV, Dykewicz MS, Bernstein DI, et al, “The Diagnosis and Management of Rhinitis: An Updated Practice Parameter,” J Allergy Clin Immunol, 2008, 122(2 Suppl):S1-84.[PubMed 18662584]

Xhance (fluticasone propionate) [prescribing information]. Yardley, PA: OptiNose US Inc; September 2017.

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)

Fluticasone (Nasal) (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(floo TIK a sone)

Brand Names: US

Flonase Allergy Relief [OTC]; Flonase Sensimist [OTC]; GoodSense Nasoflow [OTC] [DSC]; Ticaspray; Veramyst [DSC]; Xhance

Brand Names: Canada

Avamys; Flonase

What is this drug used for?
  • It is used to ease allergy signs.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to fluticasone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not use this drug to treat asthma. Talk with the doctor.
  • This drug may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • This drug may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Talk with your doctor if you come into contact with anyone who has chickenpox or measles and you have not had chickenpox, measles, or the vaccines for them.
  • If you have come into contact with anyone who has tuberculosis (TB), talk with your doctor.
  • If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
  • When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Different brands of this drug may be for use in different ages of children. Talk with the doctor before giving this drug to a child.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
What are some side effects that I need to call my doctor about right away?
  • 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:
  • 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.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Bad nose irritation.
  • Nose sores.
  • Bad nosebleeds.
  • Whistling sound when you breathe.
  • Redness or white patches in mouth or throat.
  • Change in eyesight.
  • Nose discharge that is not normal.
  • Very bad face pain.
  • Crusting in the nose.
  • Runny nose.
  • Bone pain.
  • Fever or chills.
  • Very bad sore throat.
What are some other side effects of this drug?
  • 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:
  • All products:
  • Headache.
  • Nose or throat irritation.
  • Nosebleed.
  • Cough.
  • Upset stomach or throwing up.
  • Nasal spray (Xhance):
  • Stuffy nose.
  • All products other than Xhance:
  • Stinging or sneezing may happen for a few seconds after you use this drug. Talk with your doctor if this bothers you.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Do not take this drug by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
  • Follow how to use as you have been told by the doctor or read the package insert.
  • To gain the most benefit, do not miss doses.
  • Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Some products may have different ways to prime the pump. Some pumps may also need to be primed if not used for different periods of time. Follow how and when to prime as you have been told.
  • Spray up the nose only. Do not spray onto the wall joining the two nostrils.
  • Shake well before use.
  • Blow your nose before use.
  • Check your spray use with your doctor at each visit. Read and follow the facts on how to use the spray. Make sure you use the spray the right way.
What do I do if I miss a dose?
  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature. Throw away any part not used after labeled number of doses are used.
  • Protect from heat, cold, and light.
  • Store upright with the cap on.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Fluticasone (Nasal) (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(floo TIK a sone)

Brand Names: US

Flonase Allergy Relief [OTC]; Flonase Sensimist [OTC]; GoodSense Nasoflow [OTC] [DSC]; Ticaspray; Veramyst [DSC]; Xhance

Brand Names: Canada

Avamys; Flonase

What is this drug used for?
  • It is used to ease allergy signs.
  • Nasal spray (Xhance):
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any of these drugs: Atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Do not use this drug to treat asthma. Talk with the doctor.
  • Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
  • Get your child an eye exam as you have been told by the doctor.
  • Have your child get a bone density test as you have been told by your child’s doctor.
  • Talk with the doctor if your child comes into contact with anyone who has chickenpox or measles and your child has not had chickenpox, measles, or the vaccines for them.
  • If your child has come into contact with anyone who has tuberculosis (TB), talk with the doctor.
  • If your child has had any recent nose surgery, injury, ulcers, or sores, talk with the doctor.
  • When changing from an oral steroid to another form of steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call the doctor right away if your child has any of these signs. If your child has a bad injury, has surgery, or any type of infection, he/she may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Have your child wear medical alert ID (identification).
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Different brands of this drug may be for use in different ages of children. Talk with the doctor before giving this drug to a child.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • 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 child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • 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.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Bad nose irritation.
  • Nose sores.
  • Bad nosebleeds.
  • Whistling sound when your child breathes.
  • Redness or white patches in mouth or throat.
  • Change in eyesight.
  • Nose discharge that is not normal.
  • Very bad face pain.
  • Crusting in the nose.
  • Runny nose.
  • Bone pain.
  • Fever or chills.
  • Very bad sore throat.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Nose or throat irritation.
  • Nosebleed.
  • Cough.
  • Upset stomach or throwing up.
  • Stinging or sneezing may happen for a few seconds after your child uses this drug. Talk with the doctor if this bothers your child.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Do not give this drug by mouth. Use in your child’s nose only. Keep out of your child’s mouth and eyes (may burn).
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Some products may have different ways to prime the pump. Some pumps may also need to be primed if not used for different periods of time. Follow how and when to prime as you have been told.
  • Spray up your child’s nose only. Do not spray onto the wall joining your child’s nostrils.
  • Shake well before use.
  • Have your child blow nose before use.
  • Check your child’s spray use with the doctor at each visit. Read and follow facts on how to use the spray. Make sure your child uses the spray the right way.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature. Throw away any part not used after labeled number of doses are used.
  • Protect from heat, cold, and light.
  • Store upright with the cap on.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.