Dosing & Uses
Dosage Forms & Strengths
aerosol for inhalation (Flovent HFA)
- 44mcg/actuation
- 110mcg/actuation
- 220mcg/actuation
powder for inhalation (Flovent Diskus)
- 50mcg/actuation
- 100mcg/actuation
- 250mcg/actuation
powder for inhalation (ArmonAir Digihaler)
- 55mcg/actuation
- 113mcg/actuation
- 232mcg/actuation
Asthma
Maintenance treatmentas prophylactic therapy; not indicated for relief of acute bronchospasm
Starting dosage is based on prior asthma therapy and disease severity
Inhaled aerosol (Flovent HFA)
- Prior bronchodilator use: 88 mcg (2 actuations of 44 mcg) inhaled PO q12hr; not to exceed 440 mcg q12hr
- Prior inhaled corticosteroid use: 88-220 mcg inhaled PO q12hr; not to exceed 440 mcg q12hr
- Prior PO corticosteroid use: 440 mcg inhaled PO q12hr; not to exceed 880 mcg q12hr
Inhaled powder (Flovent Diskus)
- Prior bronchodilator use: 100 mcg inhaled PO q12hr; not to exceed 500 mcg q12hr
- Prior inhaled corticosteroid use: 100-250 mcg inhaled PO q12hr; not to exceed 500 mcg q12hr
- Prior PO corticosteroid use: 500-1000 mcg inhaled PO q12hr; not to exceed 1000 mcg q12hr
Inhaled powder (ArmonAir RespiClick)
- Starting dose for patients not on inhaled corticosteroids: 55 mcg inhaled PO q12hr
- For patients who do not respond after 2 weeks, increase to a higher dose or add additional controller therapies
- Do not exceed 232 mg q12hr
Eosinophilic Esophagitis (Orphan)
Not FDA-approved for orphan indication
Orphan sponsor
- Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807
Dosing Considerations
Starting dosages >100 mcg q12hr may be considered in patients who have poorer asthma control or previously required higher-than-usual dosages of inhaled corticosteroids
Patients on long-term PO corticosteroid therapy: Do not reduce prednisone faster than 2.5-5 mg/day on weekly basis, beginning after >1 week of therapy with inhaled powder; monitor carefully
Prior PO corticosteroid use: Starting dose should be determined on basis of individual patient assessment
Esophagitis (Orphan)
Orphan designation for treatment of eosinophilic esophagitis
Sponsors
- Aptalis Pharma US, Inc, 100 Somerset Corporate Blvd, Bridgewater, NJ 08807
- Banner Life Sciences, LLC; 4125 Premier Drive; High Point, North Carolina 27265
Dosage Forms & Strengths
aerosol for inhalation (Flovent HFA)
- 44mcg/actuation
- 110mcg/actuation
- 220mcg/actuation
powder for inhalation (Flovent Diskus)
- 50mcg/actuation
- 100mcg/actuation
- 250mcg/actuation
powder for inhalation (ArmonAir Digihaler)
- 55mcg/actuation
- 113mcg/actuation
- 232mcg/actuation
Asthma
Maintenance treatment as prophylactic therapy; not indicated for relief of acute bronchospasm
Starting dosage is based on prior asthma therapy and disease severity
Inhaled aerosol (Flovent HFA)
- <4 years: Safety and efficacy not established
- 4-12 years: 88 mcg (2 actuations of 44 mcg) PO q12hr
- >12 years (prior inhaled corticosteroid use): 88-220 mcg PO q12hr; not to exceed 440 mcg q12hr
- >12 years (prior PO corticosteroid use): 440 mcg PO q12hr; not to exceed 880 mcg q12hr
Inhaled powder (Flovent Diskus)
- <4 years: Safety and efficacy not established
- 4-12 years: 50-100 mcg PO q12hr
- >12 years (prior bronchodilator use): 100 mcg PO q12hr; not to exceed 500 mcg q12hr
- >12 years (prior inhaled corticosteroid use): 100-250 mcg PO q12hr; not to exceed 500 mcg q12hr
- >12 years (prior PO corticosteroid use): 500-1000 mcg PO q12hr; not to exceed 1000 mcg q12hr
Inhaled powder (ArmonAir Digihaler)
- Not on inhaled corticosteroids: 55 mcg inhaled PO q12hr
- For patients who do not respond after 2 weeks, increase to a higher dose or add additional controller therapies
- Do not exceed 232 mg q12hr
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Oral candidiasis (<31%)
Throat irritation (3-22%)
Upper respiratory tract infection (16-18%)
Fatigue or malaise (16%)
Nasal congestion (16%)
Rhinitis (≤13%)
Musculoskeletal pain (2-12%)
Headache (5-11%)
1-10%
Nasal congestion (8%)
Sinusitis or sinus infection (4-7%)
Cough (4-6%)
Bronchitis (2-6%)
Hoarseness or dysphonia (2-6%)
Allergic rhinitis (5%)
Nasal discharge (5%)
Upper respiratory inflammation (2-5%)
Muscle injury (≤5%)
Gastrointestinal (GI) discomfort or pain (1-4%)
Frequency Not Defined
Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria)
Respiratory: Rhinitis, rhinorrhea or postnasal drip, nasal sinus disorders, laryngitis
GI: Diarrhea, loss of taste, viral infections, dyspeptic symptoms, discomfort, pain, hyposalivation
Muscular: Musculoskeletal pain, stiffness, tightness, rigidity, injuries, soreness
Other: Dizziness, migraine, fever, viral infection, pain, chest symptoms, viral skin infections, soft tissue injuries, urinary infections
Postmarketing Reports
Special senses: Aphonia, facial and oropharyngeal edema, throat soreness, irritation, cataracts
Endocrine: Cushingoid features, growth velocity reduction in children and adolescents, hyperglycemia, osteoporosis, weight gain
GI: Dental caries, tooth discoloration, esophageal candidiasis
Psychiatry: Agitation, aggression, anxiety, depression, restlessness; behavioral changes, including hyperactivity and irritability (rarely and primarily in children)
Immunologic: Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, angioedema, bronchospasm
Respiratory: Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, wheezing
Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, pruritus
Rare cases of systemic eosinophilic conditions (some with features of vasculitis consistent with Churg-Strauss syndrome, which is often treated with systemic corticosteroids)
Eye: Cataracts, blurred vision, and central serous chorioretinopathy
Nervous system disorders: Tremor
Warnings
Contraindications
Hypersensitivity to drug, components or milk proteins, which may result in anaphylaxis, angioedema, rash, and urticaria
Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
Cautions
Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex; care must be taken to avoid exposure
Nasal septum perforation, epistaxis, wheezing
Glaucoma, increased intraocular pressure, and cataracts reported in patients following long-term administration of drug; monitor closely; consider referral to an ophthalmologist in patients who develop ocular symptoms or use inhaler long term
Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); if patient exposed to chickenpox, may administer prophylaxis with varicella-zoster immune globulin (VZIG); if a patient is exposed to measles, may administer prophylaxis with pooled intramuscular immunoglobulin (IG; See respective package inserts for complete VZIG and IG prescribing information); if chickenpox develops, treatment with antiviral agents may be considered; use with caution, if at all, in patients with active or quiescent tuberculosis infections of respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
Use with caution in immunocompromised patients
Risk of infections of nose and pharynx, including Candida albicans; must rinse mouth after inhalation to reduce risk; treat with appropriate local or systemic (eg, oral) antifungal therapy while treatment continues; at times therapy may need to be interrupted
Paradoxical bronchospasm may occur with immediate increase in wheezing after dosing; if bronchospasm occurs following dosing treat immediately with an inhaled, short-acting bronchodilator; discontinued therapy immediately; and institute alternative therapy
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; monitor growth of pediatric patients receiving ICS routinely (eg. via stadiometry); to minimize systemic effects of orally inhaled corticosteroids, titrate each patient’s dosage to lowest dosage that effectively controls his/her symptoms
Decreases in bone mineral density (BMD) reported with long-term administration of products containing ICS; clinical significance of small changes in BMD with regard to longterm consequences such as fracture is unknown; monitor and treat patients with established standards of care patients with major risk factors for decreased bone mineral content, 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, anticonvulsants, oral corticosteroids)
Anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported; patients with severe milk protein allergy should not use product
Therapy not to be regarded as bronchodilator and not indicated for rapid relief of bronchospasm; instruct patient to contact physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during course of treatment; during such episodes, patients may require therapy with oral corticosteroids
Eosinophilic conditions
- In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions; some patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy; these events, have been associated (not always) with reduction and/or withdrawal of oral corticosteroid therapy following introduction of fluticasone propionate
- Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting; physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients; a causal relationship between fluticasone propionate and these underlying conditions not established
Transferring patients from systemic corticosteroid therapy
- Particular care needed for patients transferred from systemically active corticosteroids to ICS; deaths due to adrenal insufficiency during and after transfer from systemic corticosteroids to less systemically available ICS
- After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function
- During periods of stress or a severe asthma attack, instruct patients who have been withdrawn from systemic corticosteroids to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction; patients should carry warning card indicating possible need for supplementary systemic steroids in such emergencies
- Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ICS; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with ICS
- Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [AM PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids
- Patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension
- Transfer of patients from systemic corticosteroid therapy to ICS may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions)
- Systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects; if effects occur, ICS dose should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and other treatments for management of asthma symptoms should be considered
Pregnancy & Lactation
Pregnancy
There are no randomized clinical studies in pregnant women; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes (eg, pre-eclampsia in the mother, prematurity, low birth weight, and small for gestational age in the neonate;)
Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
Lactation
Fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low; concentrations in human breast milk are likely to be correspondingly low
Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Anti-inflammatory corticosteroid; exact mechanism of action is unknown, but agent has been shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids)
Absorption
Bioavailability: 30%
Onset: 24 hr (maximum, 1-2 wk)
Distribution
Protein bound: 99%
Vd: 4.2 L/kg
Metabolism
Metabolized in liver by CYP3A4
Metabolites: 17-Beta carboxylic acid
Elimination
Half-life: 11-12 hr
Excretion: Feces (parent drug), urine (<5% metabolites)
Administration
Orally Inhaled Administration
Aerosol
- Prime inhaler (4 actuations into air) before first use and after prolonged (>7 days) idleness
- Valve holding chamber and face mask may be used for younger patients
Powder
- Does not require priming
- Do not use with a spacer
- Keep the inhaler in a cool dry place; never wash or put any part of the inhaler in water
- Routine maintenance is not required; if the mouthpiece needs cleaning, gently wipe with a dry cloth or tissue as needed
- Hold your breath for about 10 seconds after inhaling; then breathe out fully
- After each dose, rinse your mouth with water and spit it out; do not swallow the water
Diskus
- Always use in a level, flat position
- Make sure the lever firmly clicks into place
Images
Patient Handout
Formulary
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