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Fluticasone (Nasal)

Pronunciation

(floo TIK a sone)

Index Terms

  • Flonase Sensimist
  • Fluticasone Furoate
  • Fluticasone Propionate
  • Xhance Nasal Spray

Dosage Forms

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, 9.9 mL, 15.8 mL) [contains benzalkonium chloride, edetate disodium, polysorbate 80]

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

Suspension, Nasal, as propionate:

Flonase: 50 mcg/actuation (16 g [DSC]) [contains benzalkonium chloride, polysorbate 80]

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) [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]

Brand Names: U.S.

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

Pharmacologic Category

  • Corticosteroid, Nasal

Pharmacology

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

Distribution

Fluticasone propionate: 4.2 L/kg; Fluticasone furoate: Vd,ss: 608 L

Metabolism

Hepatic via CYP3A4 to 17 beta-carboxylic acid (negligible activity)

Excretion

Oral: Feces (as parent drug and metabolites); Urine (<5% as metabolites)

Onset of Action

Maximal benefit may take several days or several months (Xhance)

Half-Life Elimination

IV: Fluticasone propionate: ~8 hours (~7.8 hours [Xhance]); Fluticasone furoate: ~15 hours

Protein Binding

99%

Special Populations: Hepatic Function Impairment

Accumulation of fluticasone in plasma may occur 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)

Off Label Uses

Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment)

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 rhinosinusitis

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 relief

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 [Rosenfeld 2015].

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

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: Pediatric

Allergic rhinitis (fluticasone furoate): Intranasal:

Veramyst (Rx):

Children 2 to 11 years: Initial: One spray (27.5 mcg/spray) per nostril once daily (55 mcg/day); patients not adequately responding may use 2 sprays per nostril once daily (110 mcg/day); once symptoms are controlled, dosage may be reduced to 1 spray per nostril once daily (55 mcg/day).

Children ≥12 years and Adolescents: Refer to adult dosing.

Avamys (Rx) [Canadian product]:

Children 2 to 11 years: Initial: One spray (27.5 mcg/spray) per nostril once daily (55 mcg/day); patients not adequately responding may use 2 sprays per nostril once daily (110 mcg/day); once symptoms are controlled, dosage should be reduced to 1 spray per nostril once daily (55 mcg/day). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg/day).

Children ≥12 years and Adolescents: Refer to adult dosing.

Flonase (Rx) [Canadian product]:

Children 4 to 11 years: Usual dose: 1 to 2 sprays (50 mcg/spray) per nostril once daily; maximum dose: 2 sprays per nostril once daily (200 mcg/day). Once symptoms are controlled, reduce dose to 1 spray per nostril once daily.

Adolescents 12 to 17 years: Usual dose: Two sprays (50 mcg/spray) per nostril once daily; patients with severe rhinitis may benefit from 2 sprays in each nostril twice daily; maximum dose: 400 mcg/day (4 sprays in each nostril).

Nonallergic rhinitis: Flonase (Rx) (fluticasone propionate): Intranasal: Children ≥4 years and Adolescents: Initial: One spray (50 mcg/spray) per nostril once daily (100 mcg/day); may increase to 2 sprays per nostril once daily (200 mcg/day) if response not adequate; once symptoms are controlled, may reduce to 1 spray per nostril once daily (100 mcg/day) (maximum: 2 sprays in each nostril [200 mcg]/day). Dosing should be at regular intervals.

Upper respiratory allergies (OTC): Intranasal:

Flonase Sensimist (fluticasone furoate):

Children 2 to 11 years: One spray (27.5 mcg/spray) per nostril once daily (55 mcg/day). Do not use for more than 2 months per year unless instructed by health care provider.

Children ≥12 years and Adolescents: Refer to adult dosing.

ClariSpray, Flonase Allergy Relief, Good Sense Nasoflow (fluticasone propionate):

Children 4 to 11 years: One spray (50 mcg/spray) per nostril once daily (100 mcg/day). Do not use for more than 2 months per year unless instructed by health care provider.

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

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

Administration

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 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.

Storage

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.

Drug Interactions

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

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

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

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. 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.

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

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP 2005; Wallace 2008).

Patient Education

• 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, stinging, sneezing, or pharyngitis. Have patient report immediately to prescriber signs of infection, 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, 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.

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