(floo TIK a sone)
- Flonase Sensimist
- Fluticasone Furoate
- Fluticasone Propionate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, Nasal, as furoate:
Veramyst: 27.5 mcg/spray (10 g) [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) [contains 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 [DSC]
- Corticosteroid, Nasal
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
Fluticasone propionate: 4.2 L/kg; Fluticasone furoate: Vd,ss: 608 L
Hepatic via CYP3A4 to 17 beta-carboxylic acid (negligible activity)
Oral: Feces (as parent drug and metabolites); Urine (<5% as metabolites)
Onset of Action
Maximal benefit may take several days
IV: Fluticasone propionate: ~8 hours; Fluticasone furoate: ~15 hours
Special Populations: Hepatic Function Impairment
Accumulation of fluticasone in plasma may occur in patients with hepatic impairment.
Use: Labeled Indications
Nonallergic rhinitis (Flonase): Management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients ≥4 years.
Allergic rhinitis (Veramyst, Avamys [Canadian product]): Management of seasonal and perennial allergic rhinitis in adults and pediatric patients ≥2 years
OTC labeling: Relief of hay fever or other upper respiratory allergies (eg, nasal congestion, runny nose, sneezing, itchy nose) in adults and children ≥4 years.
Adjunct to antibiotics in empiric treatment of acute bacterial rhinosinusitis (ABRS) (Chow, 2012)
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, 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
Flonase (fluticasone propionate):
US labeling: Initial: 2 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).
Canadian labeling: 2 sprays (50 mcg/spray) per nostril once daily (200 mcg/day); for severe rhinitis may administer 2 sprays in each nostril every 12 hours (maximum: 4 sprays in each nostril [400 mcg]/day).
Flonase OTC (fluticasone propionate): Initial: 2 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.
Veramyst (fluticasone furoate): Initial: 2 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 (fluticasone furoate) [Canadian product]: 2 sprays (27.5 mcg/spray) in each nostril once daily (110 mcg/day). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg/day).
Refer to adult dosing.
Flonase (fluticasone propionate):
US labeling: Children ≥4 years and Adolescents: Initial: 1 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.
Children ≥4 years to 11 years: 1 to 2 sprays (50 mcg/spray) per nostril once daily (100 to 200 mcg/day); once symptoms are controlled, 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.
Children ≥12 years and Adolescents: Refer to adult dosing.
Flonase OTC (fluticasone propionate):
Children 4 to 11 years: 1 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: Initial: 2 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.
Veramyst (fluticasone furoate):
Children 2 to 11 years: Initial: 1 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). Total daily dosage should not exceed 2 sprays in each nostril (110 mcg/day).
Children ≥12 years and Adolescents: Refer to adult dosing.
Avamys (fluticasone furoate) [Canadian product]:
Children 2 to 11 years: Initial: 1 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.
Dosing: Renal Impairment
No dosage adjustment necessary.
Dosing: Hepatic Impairment
US labeling: There are no dosage adjustments provided in the manufacturer’s labeling; use caution in moderate to severe impairment due to extensive hepatic metabolism.
Canadian labeling: No dosage adjustment is necessary; however, increased monitoring is recommended.
Nasal spray: 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: Store between 4°C to 30°C (39°F to 86°F).
Veramyst: Store between 15°C to 30°C (59°F to 86°F); do not refrigerate or freeze. Store in upright position with cap on.
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.
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Cobicistat: May increase the serum concentration of Fluticasone (Nasal). Management: Consider an alternative nasal corticosteroid when possible, particularly for longer-term concurrent use. Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Nasal). Monitor therapy
Ritonavir: May increase the serum concentration of Fluticasone (Nasal). Avoid combination
Telaprevir: May increase the serum concentration of Fluticasone (Nasal). Management: Concurrent use of telaprevir with inhaled fluticasone is not recommended, unless the risk for excessive systemic corticosteroid effects is outweighed by the potential benefits. Consider therapy modification
Tipranavir: May increase the serum concentration of Fluticasone (Nasal). Avoid combination
>10%: Central nervous system: Headache (7% to 16%)
1% to 10%:
Central nervous system: Dizziness (1% to 3%), generalized ache (1% to 3%)
Gastrointestinal: Nausea and vomiting (3% to 5%), abdominal pain (1% to 3%), diarrhea (1% to 3%)
Neuromuscular & skeletal: Back pain (1%)
Respiratory: Pharyngitis (6% to 8%), epistaxis (4% to 7%), asthma-like symptoms (3% to 7%), cough (3% to 4%), pharyngolaryngeal pain (2% to 4%), blood in nasal mucous (1% to 3%), bronchitis (1% to 3%), flu-like symptoms (1% to 3%), rhinorrhea (1% to 3%), nasal mucosa ulcer (1%)
Miscellaneous: Fever (1% to 5%)
<1% (Limited to important or life-threatening): Altered sense of smell, anaphylactoid reaction, anaphylaxis, angioedema, bronchospasm, cataract, conjunctivitis, dysgeusia, dyspnea, facial edema, glaucoma, hypersensitivity reaction, increased intraocular pressure, increased serum AST, nasal candidiasis, nasal septum perforation (rare), psychomotor agitation, second degree atrioventricular block, skin rash, tongue edema, tremor, vulvovaginal candidiasis
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercorticism 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 nasal corticosteroid 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, 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. Avoid use or use with caution in patients with latent/active tuberculosis, systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex.
• Local nasal effects: Nasal septal perforation, nasal ulceration, 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.
• 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 latent tuberculosis or in patients with untreated fungal, bacterial, or systemic viral infections. 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.
• Pediatrics: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercorticism (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).
• 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. When transitioning from systemic to intranasal fluticasone, Flonase Canadian labeling recommends a withdrawal rate of prednisone ~1 mg (or equivalent) every 4 days in closely supervised patients and every 10 days in unsupervised patients. If withdrawal symptoms appear, resume systemic steroid at previous dose for one week before attempting further dose reductions.
• Self-medication (OTC use): Discontinue use and contact healthcare provider if symptoms do not begin to improve after 7 days or new symptoms occur (eg, facial pain, thick nasal discharge, nosebleeds, whistling sound from the nose).
Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including Churg-Strauss syndrome); ocular changes; signs/symptoms of Candida infection (long-term therapy); hepatic function
Pregnancy Risk Factor
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).
• 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, pharyngitis, nausea, vomiting, or back pain. Have patient report immediately to prescriber signs of infection, severe rhinitis, nasal sores, severe nosebleeds, wheezing, redness or white patches in mouth or throat, abnormal nasal discharge, severe face pain, rhinorrhea, nasal crusting, 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.