Version May 2024
Dosage guidance:
Clinical considerations: Fluticasone furoate has a higher binding affinity for the lung glucocorticoid receptor compared to fluticasone propionate. The resulting enhanced affinity is reflected in the lower dose of fluticasone furoate compared to fluticasone propionate (Ref). Further studies are needed to elucidate a clinical effect.
Asthma , maintenance/controller (alternative agent): Note: Product selection: Individualize daily fluticasone dose based on severity of symptoms, typically as follows: low doses for mild persistent asthma, low to medium doses for moderate persistent asthma, and medium to high doses for severe persistent asthma. Select a product with a favorable dosage per actuation to improve convenience and adherence (Ref).
|
Low dose |
Medium dose |
High dose | |
|---|---|---|---|
|
Fluticasone furoate |
100 mcg/day |
100 mcg/day |
200 mcg/day |
|
Fluticasone propionate |
100 to 250 mcg/day |
>250 to 500 mcg/day |
>500 mcg/day |
Usual dosage ranges, mild to severe:
Fluticasone furoate breath activated aerosol powder inhaler (Arnuity Ellipta): Dry powder inhaler (50 mcg/actuation, 100 mcg/actuation, or 200 mcg/actuation): Oral inhalation: 100 to 200 mcg once daily; maximum dose: 200 mcg/day. Note: Some experts may use the pediatric 50 mcg inhaler (off label) to administer a dose of 50 mcg once daily for mild persistent asthma (Ref).
Fluticasone propionate breath activated aerosol powder inhalers:
ArmonAir Digihaler, ArmonAir RespiClick, Aermony Respiclick [Canadian product]: Dry powder inhaler (55 mcg/actuation, 113 mcg/actuation, or 232 mcg/actuation): Oral inhalation: 55 to 232 mcg twice daily; maximum dose: 464 mcg/day.
Flovent Diskus: Dry powder inhaler (50 mcg/actuation, 100 mcg/actuation, or 250 mcg/actuation): Oral inhalation: 50 to 1,000 mcg twice daily; maximum dose: 2,000 mcg/day. Note: There is limited evidence for additional improvement with dose increases >1,000 mcg/day (Ref).
Fluticasone propionate aerosol inhalation:
Flovent HFA: Metered-dose inhaler (US product: 44 mcg/actuation, 110 mcg/actuation, or 220 mcg/actuation): Oral inhalation: 88 to 440 mcg twice daily; maximum dose: 1,760 mcg/day. Note: There is limited evidence for additional improvement with dose increases >1,000 mcg/day (Ref).
Flovent HFA: Metered-dose inhaler (Canadian product: 50 mcg/actuation, 125 mcg/actuation, or 250 mcg/actuation): Oral inhalation: 50 to 1,000 mcg twice daily; maximum dose: 2,000 mcg/day. Note: There is limited evidence for additional improvement with dose increases >1,000 mcg/day (Ref).
Titration: For patients whose symptoms are not adequately controlled after 2 to 4 weeks of therapy, may increase controller therapy in a step-wise fashion. For patients whose symptoms are well controlled for 3 to 6 months on a stable regimen, may reduce controller therapy in a step-wise fashion (Ref).
Bronchiolitis obliterans, post–hematopoietic cell transplantation (off-label use):
Note: For patients with extrapulmonary graft-versus-host disease, administer as part of an appropriate immunosuppressive regimen (Ref).
Flovent HFA: Fluticasone propionate aerosol inhalation: Oral inhalation: 440 mcg twice daily. Note: If airway obstruction is symptomatic, administer with an inhaled long-acting beta agonist (LABA) or switch to an inhaled corticosteroid (ICS)/LABA combination inhaler (Ref).
Chronic obstructive pulmonary disease, maintenance (off-label use):
Note: In patients with persistent exacerbations on dual long-acting bronchodilator therapy or elevated eosinophil count (Group E), consider triple therapy (inhaled corticosteroid, long-acting beta agonist, and long-acting muscarinic antagonist). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Arnuity Ellipta: Fluticasone furoate breath-activated aerosol powder: Oral inhalation: 100 mcg once daily as a component of dual or triple combination therapy (Ref). Note : Some clinical trials used agents in combination with fluticasone furoate that are not currently commercially available. A triple-ingredient inhaler containing fluticasone furoate, umeclidinium, and vilanterol is commercially available.
Flovent Diskus: Fluticasone propionate breath-activated aerosol powder: Oral inhalation: 250 mcg twice daily as a component of dual or triple combination therapy; may increase up to 500 mcg twice daily based on response and concomitant disease states (eg, asthma); maximum daily dose: 1,000 mcg/day (Ref).
Eosinophilic esophagitis (off-label use):
Note: May be used in combination with nonpharmacologic measures and acid suppression therapy. Administer fluticasone by spraying the aerosol inhaler (without a spacer) into the throat; patient should not inhale when dose is being delivered; instead, patient should swallow the accumulated liquid. Instruct patient to not eat or drink for 30 minutes after administration (Ref).
Flovent HFA: Fluticasone propionate aerosol inhalation: Oral: Induction therapy: 440 to 880 mcg swallowed (not inhaled) twice daily (Ref). Duration of induction therapy is 4 to 8 weeks. Once clinical remission is achieved, the dose may be gradually decreased to the lowest dose that provides symptom control; maximum dose: 1,760 mcg/day (Ref).
Nonasthmatic eosinophilic bronchitis: Fluticasone propionate aerosol inhalation: Oral: 44 to 110 mcg twice daily (Ref). Doses as high as 500 mcg twice daily have been studied (using a 250 mcg/actuation product [not available in the US]) (Ref). Continue treatment for at least 2 months to decrease risk of relapse (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Arnuity Ellipta: No dosage adjustment necessary.
ArmonAir Digihaler, ArmonAir RespiClick, Flovent Diskus, and Flovent HFA: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, fluticasone is primarily cleared in the liver and plasma levels may be increased in patients with hepatic impairment; closely monitor.
Arnuity Ellipta:
Mild impairment: No dosage adjustment necessary.
Moderate to severe impairment: Systemic exposure is increased up to 3-fold; use with caution and closely monitor.
Refer to adult dosing.
(For additional information see "Fluticasone (oral inhalation): Pediatric drug information")
Asthma , maintenance therapy: Note: Initial dose is based on previous asthma therapy, current control, and risk of exacerbation. If adequate response is not seen after 2 weeks of initial dosage, increase dosage; once adequate control achieved, doses should be titrated to the lowest effective dose.
Flovent HFA (Fluticasone propionate):
US labeling: Metered-dose inhaler: Oral inhalation:
Children 4 to 11 years: 88 mcg twice daily.
Children ≥12 years and Adolescents: Initial: 88 mcg twice daily; may start doses above 88 mcg twice daily in poorly-controlled patients or in those who previously required higher doses of inhaled corticosteroids; maximum dose: 880 mcg twice daily.
Canadian labeling: Metered-dose inhaler: Oral inhalation:
Children <4 years: 100 mcg twice daily.
Children ≥4 years and Adolescents <16 years: 100 mcg twice daily; if lower or high doses are required, Flovent Diskus should be used to ensure the dose is 2 inhalations twice daily.
Adolescents ≥16 years:
Mild asthma: 100 to 250 mcg twice daily.
Moderate asthma: 250 to 500 mcg twice daily.
Severe asthma: 500 mcg twice daily; may increase up to 1,000 mcg twice daily in very severe patients.
Asthma guidelines:
National Asthma Education and Prevention Program guidelines (Ref): Fluticasone propionate (HFA): Metered-dose inhaler: Note: Administer in divided doses twice daily:
"Low" dose:
Infants and Children ≤4 years: 176 mcg/day.
Children 5 to 11 years: 88 to 176 mcg/day.
Children ≥12 years and Adolescents: 88 to 264 mcg/day.
"Medium" dose:
Infants and Children ≤11 years: >176 to 352 mcg/day.
Children ≥12 years and Adolescents: >264 to 440 mcg/day.
"High" dose:
Infants and Children ≤11 years: >352 mcg/day.
Children ≥12 years and Adolescents: >440 mcg/day.
Global Initiative for Asthma Guidelines (Ref): Fluticasone propionate (HFA): Metered-dose inhaler:
Children 4 to 5 years: "Low" dose: 100 mcg/day.
Children 6 to 11 years:
"Low" dose: 100 to 200 mcg/day.
"Medium" dose: >200 to 500 mcg/day.
"High" dose: >500 mcg/day.
Children ≥12 years and Adolescents:
"Low" dose: 100 to 250 mcg/day.
"Medium" dose: >250 to 500 mcg/day.
"High" dose: >500 mcg/day.
Flovent Diskus (Fluticasone propionate):
US labeling: Dry powder inhaler: Oral inhalation:
Children 4 to 11 years: Initial: 50 mcg twice daily; doses above 50 mcg twice daily may be considered in patients poorly controlled or in those who previously required higher doses of inhaled corticosteroids; maximum dose: 100 mcg twice daily.
Children ≥12 years and Adolescents: Initial: 100 mcg twice daily; doses above 100 mcg twice daily may be considered in poorly controlled patients or in those who previously required higher doses of inhaled corticosteroids; maximum dose: 1,000 mcg twice daily.
Canadian labeling: Dry powder inhaler: Oral inhalation:
Children ≥4 years and Adolescents <16 years: Initial: 100 mcg twice daily; may increase up to 200 mcg twice daily if necessary.
Adolescents ≥16 years:
Mild asthma: 100 to 250 mcg twice daily.
Moderate asthma: 250 to 500 mcg twice daily.
Severe asthma: 500 mcg twice daily; may increase up to 1,000 mcg twice daily in very severe patients.
Asthma guidelines:
National Asthma Education and Prevention Program Guidelines (Ref): Dry powder inhaler: Note: Administer in divided doses twice daily:
Children 5 to 11 years:
"Low" dose: 100 to 200 mcg/day.
"Medium" dose: >200 to 400 mcg/day.
"High" dose: >400 mcg/day.
Children ≥12 years and Adolescents:
"Low" dose: 100 to 300 mcg/day.
"Medium" dose: >300 to 500 mcg/day.
"High" dose: >500 mcg/day.
Global Initiative for Asthma Guidelines (Ref): Dry powder inhaler:
Children 6 to 11 years:
"Low" dose: 100 to 200 mcg/day.
"Medium" dose: >200 to 400 mcg/day.
“High" dose: >400 mcg/day.
Children ≥12 years and Adolescents:
"Low" dose: 100 to 250 mcg/day.
"Medium" dose: >250 to 500 mcg/day.
"High" dose: >500 mcg/day.
Arnuity Ellipta (fluticasone furoate): Dry powder inhaler: Oral inhalation:
Children 5 to 11 years: 50 mcg once daily.
Children ≥12 years and Adolescents: Initial: 100 mcg once daily; doses above 100 mcg once daily may be considered in poorly-controlled patients or in those who previously required higher doses of inhaled corticosteroids. Maximum dose: 200 mcg once daily.
Asthma guidelines: Global Initiative for Asthma Guidelines (Ref): Dry powder inhaler:
Children ≥12 years and Adolescents:
"Low" dose: 100 mcg/day.
"High" dose: 200 mcg/day.
ArmonAir Digihaler, ArmonAir RespiClick (fluticasone propionate): Dry powder inhaler: Children ≥12 years and Adolescents: Oral inhalation: Dosing based on previous asthma therapy: Note: ArmonAir RespiClick discontinued in the US for >1 year.
No prior treatment with inhaled corticosteroids: Initial: 55 mcg twice daily; maximum: 232 mcg twice daily.
Prior treatment with inhaled corticosteroid: 55 mcg to 232 mcg twice daily (base starting dosage on strength of previous inhaled corticosteroid and disease severity); maximum: 232 mcg twice daily.
Asthma; mild flare, exacerbation: Limited data available:
Children ≥12 years and Adolescents with mild to moderate asthma, no prior history of life-threatening asthma exacerbations, and with good self-management skills:
It is recommended to temporarily quadruple the inhaled corticosteroid dose early in the course of a mild flare to decrease the severity of an asthma exacerbation. After symptoms stabilize or after a maximum of 14 days of quadrupled dose, whichever occurs first, patients should be returned to their baseline dose (Ref). Quadrupling the inhaled corticosteroid dose has been shown to decrease the severity of an asthma exacerbation in select patients. In a randomized trial of adolescents ≥16 years and adults (n=1,871), temporarily quadrupling the inhaled corticosteroid dose when asthma control began to deteriorate resulted in fewer severe asthma exacerbations (ie, less treatment with systemic glucocorticoids or unscheduled appointments for asthma) compared to patients who maintained their inhaled corticosteroid dose (Ref). No data for quadrupling the dose in patients <16 years of age has been published. Quintupling the dose of inhaled corticosteroids (fluticasone) in children 5 to 11 years of age was not shown to reduce the rate of severe exacerbations and may have been associated with adverse effects (decreased linear growth, particularly in patients <8 years of age) (Ref).
Bronchopulmonary dysplasia (BPD), treatment: Limited data available: Infants: Fluticasone propionate: Oral inhalation: Some centers have used 2 to 4 puffs (44 mcg/puff) every 12 hours via a face mask and a spacer. One trial used fixed doses administered via a spacer and neonatal anesthesia bag (into ventilator, directly into nasopharyngeal endotracheal tube, or with a face mask) in 16 former preterm neonates (GA: ≤32 weeks; PNA: 28 to 60 days); chest radiograph score was improved compared to placebo; the treatment group had increased blood pressure compared to baseline; the authors conclude that the trial results do not support the use of fluticasone in oxygen-dependent patients with moderate BPD; exact dosing cannot be replicated in the US with available products (Ref).
Body weight:
0.5 to 1.2 kg: 125 mcg every 12 hours for 3 weeks, followed by 125 mcg once daily for the 4th week.
≥1.2 kg: 250 mcg every 12 hours for 3 weeks, followed by 250 mcg once daily for the 4th week.
Eosinophilic esophagitis (EoE): Limited data available:
Note: Patients use an oral inhaler without a spacer and swallow the medication. Optimal dose and dosing regimen are not established (Ref). Dose should be individualized to the lowest effective dose based upon clinical response; tapering should be considered due to risk of adrenal suppression and has been reported in some clinical trials (Ref). Studies performed using fluticasone propionate.
Induction and maintenance (short-term):
Twice-daily dosing: Oral (swallowed):
Children ≥3 years and Adolescents: Initial: 440 to 880 mcg twice daily; titrate to response; 3 months is reported usual duration of initial therapy (Ref). Dosing based on small randomized, double-blind, placebo-controlled trials and retrospective reviews (Ref). In a double-blind, placebo-controlled trial, patients with active EoE were randomized to receive fluticasone 880 mcg twice daily (n=28, mean age: 12.2 years [range: 3.54 to 26.9 years]) or placebo; after 3 months of therapy, 65% to 77% (significant) of fluticasone-treated patients achieved full or partial response compared to none in the placebo arm; in complete responders, the dose was reduced to 880 mcg once daily for 3 additional months. In those who did not respond, the starting dose was continued for another 3 months; however, there was no additional benefit observed in this group of patients (Ref). In another double-blind, placebo-controlled trial, patients with EoE received fluticasone 440 mcg twice daily (n=21, mean age: 8.5 years [range: 3 to 16 years] or placebo (n=15, mean age: 11.2 years [range: 3 to 18 years]); remission occurred in 50% of patients receiving fluticasone compared to 9% who received placebo (Ref).
Four-times-daily dosing (Ref): Oral (swallowed):
Children ≤10 years: 110 mcg/spray: Initial: 220 mcg 4 times daily for 4 weeks, then taper over the next 8 weeks as follows: 220 mcg 3 times daily for 3 weeks, 220 mcg twice daily for 3 weeks, 220 mcg daily for 2 weeks.
Children ≥11 years and Adolescents: 220 mcg/spray: Initial: 440 mcg 4 times daily for 4 weeks, then taper over the next 8 weeks as follows: 440 mcg 3 times daily for 3 weeks, 440 mcg twice daily for 3 weeks, 440 mcg daily for 2 weeks.
Maintenance (long-term):
Twice-daily dosing (Ref): Oral (swallowed):
Children 2 to 4 years: 44 mcg/spray: 88 mcg twice daily.
Children 5 to 10 years: 110 mcg/spray: 220 mcg twice daily.
Children ≥11 years and Adolescents: 220 mcg/spray: 440 mcg twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Inhalation:
Arnuity Ellipta (Fluticasone furoate): Children ≥5 years and Adolescents: No dosage adjustment necessary.
ArmonAir Digihaler, ArmonAir RespiClick, Flovent Diskus, and Flovent HFA (Fluticasone propionate): There are no dosage adjustment provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, fluticasone is primarily eliminated in the liver and serum concentrations may be elevated in patients with hepatic impairment. Use with caution and closely monitor.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: Oral candidiasis (2% to 31%)
Nervous system: Fatigue (≤16%), headache (5% to 14%), malaise (≤16%)
Neuromuscular & skeletal: Arthralgia (17%), musculoskeletal pain (3% to 12%)
Respiratory: Nasal congestion (16%), rhinitis (3% to 13%), sinusitis (≤33%), throat irritation (≤22%), upper respiratory tract infection (6% to 31%)
1% to 10%:
Cardiovascular: Hypertension (<3%)
Dermatologic: Pruritus (6%), skin rash (8%)
Gastrointestinal: Gastrointestinal distress (≤4%), gastrointestinal pain (≤4%), nausea and vomiting (8% to 9%), toothache (3%), viral gastroenteritis (3%), viral gastrointestinal infection (3% to 5%)
Genitourinary: Malignant neoplasm of breast (≤1%)
Infection: Abscess (≤1%), influenza (<3%), viral infection (5%)
Nervous system: Dizziness (<3%), pain (10%), subarachnoid hemorrhage (≤1%), voice disorder (≤9%)
Neuromuscular & skeletal: Limb pain (<3%), muscle injury (2% to 5%), muscle spasm (<3%), sprain (<3%)
Respiratory: Bronchitis (2% to 8%), cough (5% to 9%), epistaxis (<3%), hoarseness (≤9%), nasopharyngitis (5% to 8%), oropharyngeal candidiasis (3%), oropharyngeal pain (3%), pharyngitis (4%), respiratory tract infection (<3%), upper respiratory tract inflammation (2% to 5%), viral respiratory tract infection (5% to 9%)
Miscellaneous: Accidental injury (2% to 5%), fever (≤7%)
Frequency not defined:
Cardiovascular: Edema, palpitations
Dermatologic: Acne vulgaris, dermatitis, dermatologic disorder, eczema, folliculitis, photodermatitis, viral skin infection
Endocrine & metabolic: Cushingoid appearance, fluid volume disorder, weight gain
Gastrointestinal: Change in appetite, diarrhea, dyspepsia, gastrointestinal signs and symptoms, mouth pain, oral mucosa ulcer, oral mucosal erythema, oral rash, tongue disease
Genitourinary: Bacterial reproductive infection, urinary tract infection
Hematologic & oncologic: Polyp (ENT)
Infection: Bacterial infection, fungal infection
Nervous system: Migraine, mood disorder
Ophthalmic: Blepharoconjunctivitis, conjunctivitis, keratitis
Respiratory: Allergic rhinitis, constriction of the pharynx, ENT signs and symptoms, laryngitis, rhinorrhea
Miscellaneous: Soft tissue injury, swelling
Postmarketing:
Cardiovascular: Chest symptoms, chest tightness
Dermatologic: Allergic skin reaction, ecchymoses
Endocrine & metabolic: Hyperglycemia
Gastrointestinal: Dental caries, dental discomfort, esophageal candidiasis, gastrointestinal disease, mouth disease, staining of tooth
Hematologic & oncologic: Bruise
Hypersensitivity: Facial edema, hypersensitivity reaction (including anaphylaxis, angioedema), type IV hypersensitivity reaction
Nervous system: Aggressive behavior, agitation, anxiety, aphonia, behavioral changes, depression, hyperactive behavior, irritability, restlessness
Neuromuscular & skeletal: Linear skeletal growth rate below expectation, osteoporosis
Ophthalmic: Blurred vision, cataract, glaucoma, increased intraocular pressure, retinopathy (central serous)
Respiratory: Bronchospasm, dyspnea, exacerbation of asthma, oropharyngeal edema, paradoxical bronchospasm, pneumonia, wheezing
Hypersensitivity to fluticasone or any component of the formulation; severe hypersensitivity to milk proteins or lactose (ArmonAir Digihaler, ArmonAir RespiClick, Arnuity Ellipta, Flovent Diskus); primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
Canadian labeling: Additional contraindications (not in US labeling): Flovent HFA and Flovent Diskus: Untreated fungal, bacterial, or tubercular infections of the respiratory tract.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods; has also been reported in pediatric patients with use of inhaled corticosteroids administered orally (Ahmet 2016). HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled corticosteroids 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. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroids (ICS) should be given stress doses of hydrocortisone IV during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007). An eosinophilic esophagitis trial evaluated the impact of discontinuation of corticosteroid (oral budesonide or fluticasone, duration of therapy: 104.6 ± 23.7 days) in pediatric patients and showed 65.5% of subjects had adrenal suppression (AS) (diagnosed by low-dose ACTH stimulation test) and was further characterized as long-term with a median duration of 43 weeks (Ahmet 2016).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue fluticasone and institute alternative therapy.
• Hypersensitivity: Immediate hypersensitivity reactions (eg, angioedema, bronchospasm, hypotension, rash, urticaria), including anaphylaxis, may occur.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use if possible in patients with ocular herpes; tuberculosis (TB) infection (latent TB) or disease (active TB) of the respiratory tract; or viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox and measles should be avoided; 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.
• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.
• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.
Disease-related concerns:
• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute episodes of asthma requiring intensive measures.
• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, antiseizure medications or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.
• Hepatic impairment: Use with caution in patients with hepatic impairment. Impairment of liver function may lead to accumulation of fluticasone in plasma.
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.
• Pneumonia: Inhaled corticosteroids, including fluticasone, have been associated with an increased risk of pneumonia in some long-term studies (>6 months) in COPD patients (Dransfield 2013; Yang 2012). In addition, an observational study found a reduction in this risk when the inhaled corticosteroid was discontinued, particularly so with fluticasone (Suissa 2015).
Special populations:
• Pediatric: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• ArmonAir Digihaler, ArmonAir RespiClick, Arnuity Ellipta, and Flovent Diskus: May contain lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.
Other warnings/precautions:
• Discontinuation of therapy: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms when used both as inhalation and orally (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
• Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.
Although recommended in children ≥12 years and adolescents, using higher doses (quintupled) in children <12 years of age has not shown efficacy and may be associated with a higher risk of adverse effects. A study in children 5 to 11 years of age with mild to moderate persistent asthma evaluated quintupling the dose of the inhaled corticosteroid (fluticasone) following the early signs of decreased asthma control; results showed that quintupled fluticasone dosages did not reduce the rate of severe exacerbations and may have been associated adverse effects (decreased linear growth, particularly in patients <8 years of age) (Jackson 2018).
ArmonAir RespiClick has been discontinued in the United States for >1 year.
Flovent HFA 10.6 g and 12 g canisters contain 120 inhalations.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol, Inhalation, as propionate:
Flovent HFA: 44 mcg/actuation (10.6 g [DSC]); 110 mcg/actuation (12 g [DSC]); 220 mcg/actuation (12 g [DSC])
Generic: 44 mcg/actuation (10.6 g); 110 mcg/actuation (12 g); 220 mcg/actuation (12 g)
Aerosol Powder Breath Activated, Inhalation:
ArmonAir Digihaler: 55 mcg/actuation (1 ea); 113 mcg/actuation (1 ea); 232 mcg/actuation (1 ea) [contains alpha-lactose monohydrate]
Aerosol Powder Breath Activated, Inhalation, as furoate:
Arnuity Ellipta: 50 mcg/actuation (30 ea); 100 mcg/actuation (14 ea, 30 ea); 200 mcg/actuation (14 ea, 30 ea) [contains lactose monohydrate]
Aerosol Powder Breath Activated, Inhalation, as propionate:
Flovent Diskus: 50 mcg/actuation (60 ea [DSC]); 100 mcg/actuation (28 ea [DSC], 60 ea [DSC]); 250 mcg/actuation (28 ea [DSC], 60 ea [DSC]) [contains lactose]
Generic: 50 mcg/actuation (60 ea); 100 mcg/actuation (60 ea); 250 mcg/actuation (60 ea)
Yes
Aerosol (Fluticasone Propionate HFA Inhalation)
44 mcg/ACT (per gram): $22.00
110 mcg/ACT (per gram): $26.01
220 mcg/ACT (per gram): $40.41
Aerosol powder (ArmonAir Digihaler Inhalation)
55 mcg/ACT (per each): $315.59
113 mcg/ACT (per each): $315.59
232 mcg/ACT (per each): $394.82
Aerosol powder (Arnuity Ellipta Inhalation)
50 mcg/ACT (per each): $8.34
100 mcg/ACT (per each): $8.34
200 mcg/ACT (per each): $11.17
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, Inhalation:
Flovent HFA: 50 mcg/actuation (6 g, 13 g); 125 mcg/actuation (7.5 g, 13 g); 250 mcg/actuation (7.5 g, 13 g)
Generic: 50 mcg/actuation (1 ea); 125 mcg/actuation (1 ea); 250 mcg/actuation (1 ea)
Aerosol Powder Breath Activated, Inhalation, as furoate:
Arnuity Ellipta: 100 mcg/actuation (14 ea, 30 ea); 200 mcg/actuation (14 ea, 30 ea) [contains lactose monohydrate]
Aerosol Powder Breath Activated, Inhalation, as propionate:
Aermony RespiClick: 55 mcg/actuation (1 ea); 232 mcg/actuation (1 ea); 113 mcg/actuation (1 ea) [contains lactose monohydrate]
Flovent Diskus: 100 mcg/actuation (1 ea); 250 mcg/actuation (1 ea); 500 mcg/actuation (1 ea) [contains lactose, milk protein]
Oral inhalation:
Dry powder inhaler:
ArmonAir RespiClick: Administer the dose at approximately the same time every day. Does not require priming and do not use with a spacer or volume holding chamber. Following administration, rinse mouth with water after use (do not swallow). Do not wash or place any part of inhaler in water; if mouthpiece needs cleaning, gently wipe with a dry cloth or tissue. Discard inhaler 30 days after opening the foil pouch or when the counter reads "0" (whichever comes first).
ArmonAir Digihaler: Administer the dose at approximately the same time every day. Does not require priming and do not use with a spacer or volume holding chamber. Following administration, rinse mouth with water after use (do not swallow). Do not wash or place any part of inhaler in water; if mouthpiece needs cleaning, gently wipe with a dry cloth or tissue. Discard inhaler 30 days after opening the foil pouch or when the counter reads "0" (whichever comes first).
Arnuity Ellipta: Administer the dose at the same time every day. Do not shake inhaler. When ready to use, open and prepare mouthpiece of the inhaler and slide the cover down to activate the first dose. Exhale fully (not into mouthpiece), take one deep breath through mouth without blocking air vents and hold breath for about 3 to 4 seconds. If the cover is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in one inhalation. Following administration, rinse mouth with water after use (do not swallow). Routine cleaning of the inhaler is not required; may clean the mouthpiece if needed, using a dry tissue, before the cover is closed. Discard inhaler 6 weeks after opening the foil tray or when the counter reads "0" (device is not reusable).
Flovent Diskus: Do not use with a spacer device. Do not exhale into Diskus. Do not wash or take apart. Use in horizontal position; do not tilt. Rinse mouth with water (without swallowing) after each use. Discard after 6 weeks (50 mcg diskus) or after 2 months (100 mcg and 250 mcg diskus) once removed from protective pouch or when the dose counter reads "0", whichever comes first (device is not reusable).
Metered dose inhaler:
Flovent HFA: Shake container thoroughly for 5 seconds before each inhalation. Use inhaler on inspiration. Allow 30 seconds between inhalations. Rinse mouth with water (without swallowing) after each use. Inhaler must be primed before first use, when not used for 7 days, or if dropped. To prime the first time, release 4 sprays into air; shake well for 5 seconds before each spray and spray away from face. The counter should now read "120". If dropped or not used for 7 days, prime by shaking well for 5 seconds and releasing a single test spray. Patient should contact pharmacy for refill when the dose counter reads "020". Discard device when the dose counter reads "000". Do not use "float" test to determine contents. Clean the inhaler at least once weekly; use a cotton swab dampened with water to clean circular opening of the metal canister and wipe the inside of the mouthpiece with a tissue dampened with water. The use of a spacer may be recommended in certain patient populations (eg, young children, elderly) (Ref).
Oral (off-label use/route): For the treatment of eosinophilic esophagitis (off-label use), fluticasone is administered orally with a metered-dose inhaler without the use of a spacer. Administer as a spray into the mouth and swallow (do not inhale). Patients should not rinse, eat, or drink for 30 to 60 minutes after administration (Ref).
Oral inhalation: Rinse mouth with water (without swallowing) after inhalation to decrease chance of oral candidiasis.
Metered-dose inhaler: Flovent HFA (Fluticasone propionate): Shake canister well for 5 seconds before each spray. Inhaler must be primed before first use with 4 test sprays (spray into air away from face, shake well for 5 seconds between sprays) and primed again with 1 test spray if not used for >7 days or if dropped. Use a spacer device for children <5 years of age and consider adding a face mask for infants and children <4 years of age (Ref). Patient should contact pharmacy for refill when the dose counter reads "020." Discard device when the dose counter reads "000." Do not try to alter numbers on counter or remove the counter from the metal canister. Do not immerse canister into water (ie, do not use "float test" to determine contents). Clean the inhaler at least once weekly; use a cotton swab dampened with water to clean circular opening of the metal canister and wipe the inside of the mouthpiece with a tissue dampened with water.
Dry powder inhaler:
ArmonAir Digihaler, ArmonAir RespiClick (Fluticasone propionate): Administer the dose at approximately the same time every day. Does not require priming and do not use with a spacer or volume holding chamber. Do not wash or place any part of inhaler in water; if mouthpiece needs cleaning, gently wipe with a dry cloth or tissue. Patient should contact pharmacy for refill when the dose counter reads "020." Discard inhaler 30 days after opening the foil pouch or when the counter reads "0," whichever comes first (device is not reusable).
Arnuity Ellipta (Fluticasone furoate): Administer the dose at the same time every day. Do not shake inhaler. When ready to use, open and prepare mouthpiece of the inhaler and slide the cover down to activate the first dose. Exhale fully (not into mouthpiece), take one deep breath through mouth without blocking air vents and hold breath for about 3 to 4 seconds. If the cover is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in one inhalation. Routine cleaning of the inhaler is not required; may clean the mouthpiece if needed, using a dry tissue, before the cover is closed. Discard inhaler 6 weeks after opening the foil tray or when the counter reads "0," whichever comes first (device is not reusable).
Flovent Diskus (Fluticasone propionate): Do not use with spacer device. Do not exhale into Diskus. Do not wash or take apart. Activate and use Diskus in horizontal position; do not tilt. Discard after 6 weeks (50 mcg diskus) or after 2 months (100 mcg and 250 mcg diskus) once removed from protective pouch or when the dose counter reads “0,” whichever comes first (device is not reusable).
Oral (swallowed): Note: This method of administration is for treatment of eosinophilic esophagitis only. Use metered dose inhaler. Do not use a spacer. Shake canister well for 5 seconds before each spray. Prime inhaler as outlined above. Actuate inhaler and spray medication into pharynx; swallow the medication (rather than inhale). Do not eat, drink, or rinse mouth for 30 minutes following administration (Ref).
Asthma, maintenance/controller:
ArmonAir Digihaler, ArmonAir RespiClick, Flovent Diskus, and Flovent HFA: Maintenance treatment of asthma as prophylactic therapy in patients ≥4 years of age (Flovent Diskus and Flovent HFA) or ≥12 years of age (ArmonAir Digihaler and ArmonAir RespiClick).
Arnuity Ellipta: Maintenance treatment of asthma in patients ≥5 years of age.
Limitations of use: Not indicated for relief of acute bronchospasm.
Bronchiolitis obliterans, post–hematopoietic cell transplantation; Chronic obstructive pulmonary disease, maintenance; Eosinophilic esophagitis (oral); Nonasthmatic eosinophilic bronchitis
Arnuity Ellipta may be confused with Anoro Ellipta, Breo Ellipta, Incruse Ellipta, and Trelegy Ellipta; Ellipta is the inhaler delivery system trademark not a medication.
Flovent may be confused with Flonase
Allegro: Brand name for fluticasone [Israel], but also the brand name for frovatriptan [Germany]
Allegro [Israel] may be confused with Allegra and Allegra-D brand names for fexofenadine and fexofenadine/pseudoephedrine, respectively [US, Canada, and multiple international markets]
Flovent [US, Canada] may be confused with Flogen brand name for naproxen [Mexico]; Flogene brand name for piroxicam [Brazil]
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Fluticasone (Oral Inhalation). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Oral Inhalation). Management: Consider alternatives to this combination if possible. Coadministration of fluticasone propionate and strong CYP3A4 inhibitors is not recommended. If combined, monitor patients for systemic corticosteroid adverse effects (eg, adrenal suppression). Risk D: Consider therapy modification
Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination
Nirmatrelvir and Ritonavir: May increase the serum concentration of Fluticasone (Oral Inhalation). Risk C: Monitor therapy
Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy
Uncontrolled asthma may negatively affect fertility by increasing time to pregnancy and reducing birth rate. Fertility may be improved in patients adequately treated with inhaled corticosteroids (Couillard 2021; ERS/TSANZ [Middleton 2020]). Inhaled corticosteroids used for the treatment of asthma should not be discontinued in patients planning to become pregnant (GINA 2023). The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]).
Fluticasone can be detected in cord blood following maternal use via oral inhalation during pregnancy (Battista 2016).
Maternal use of inhaled corticosteroids (ICS) in usual doses is not associated with an increased risk of fetal malformations; a small risk of malformations was observed in one study following high maternal doses of an alternative ICS (ERS/TSANZ [Middleton 2020]).
Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2023).
ICS are recommended for the treatment of asthma during pregnancy. Due to the risk of exacerbations, stepping down or stopping ICS should not be done during pregnancy (GINA 2023). Fluticasone oral inhalation is considered compatible for use during pregnancy. Pregnant patients adequately controlled on fluticasone for asthma may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant patients may be preferred. The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).
Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.
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 continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Fluticasone oral inhalation is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).
ArmonAir Digihaler, ArmonAir RespiClick, Arnuity Ellipta, and Flovent Diskus may contain lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.
Growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; signs/symptoms of oral candidiasis; possible eosinophilic conditions (including Churg-Strauss syndrome); FEV1, peak flow, and/or other pulmonary function tests; asthma symptoms; bone mineral density; hepatic impairment; glaucoma/cataracts
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. The effectiveness of inhaled fluticasone is due to its direct local effect.
Onset of action: Maximal benefit may take 1 to 2 weeks or longer.
Absorption: Absorbed systemically primarily via lungs (Flovent Diskus: ~18%); minimal GI absorption (<1%) due to presystemic metabolism.
Distribution: 4.2 L/kg.
Protein binding: >99%.
Metabolism: Hepatic via CYP3A4 to 17β-carboxylic acid (negligible activity).
Bioavailability: Oral inhalation: 13.9%; Flovent Diskus: ~8%.
Half-life elimination: IV: ~8 hours; Oral inhalation: Fluticasone furoate: 24 hours (plasma elimination phase following repeat dosing); Fluticasone propionate: ~11.2 hours (terminal half-life).
Time to peak, plasma: 0.5 to 1 hour.
Excretion: Feces (as parent drug and metabolites); urine (<5% as metabolites).
Hepatic function impairment: Accumulation of fluticasone in plasma may occur.
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