Classes
DEA Class; Rx
Common Brand Names; Arnuity Ellipta
- Corticosteroids, Inhalants
fluticasone intranasal (Rx, OTC)
- Classes: Corticosteroids, Intranasal
fluticasone topical (Rx)
- Classes: Corticosteroids, Topical
fluticasone inhaled (Rx)
- Classes: Corticosteroids, Inhalants
Description
Synthetic fluorinated corticosteroid; available in products used topically, nasally, and by oral inhalation
Topical products are mostly of medium potency and used for corticosteroid-responsive dermatoses in adult and pediatric patients; a few products are of higher potency
Used via oral inhalation for maintenance treatment of asthma or COPD; nasal products used for allergic/non-allergic rhinitis and for nasal polyps
Indications
Indicated for maintenance treatment of asthma as prophylactic therapy
Contraindications
Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to drug
Adverse Effects
- Nasopharyngitis (8-13%)
- Headache (6-13%)
- Bronchitis (4-7%)
- Sinusitis (4-7%)
- Influenza (4-7%)
- Pharyngitis (3-6%)
- URT infection (2-6%)
- Oropharyngeal pain (3-4%)
- Toothache (3%)
- Back pain (3%)
- Viral gastroenteritis (3%)
- Abdominal pain (3%)
- Cough (3%)
- Pruritus (2.9%)
- Dryness (1.2%)
- Skin irritation: (3%)
- Eczema (1%)
- Telangiectasia (2-5%)
- Numbness of fingers (1%)
- Oral candidiasis (<31%)
- Throat irritation (3-22%)
- Upper respiratory tract infection (16-18%)
- Fatigue or malaise (16%)
- Nasal congestion (16%)
- Rhinitis (≤13%)
Warnings
Localized infections of the mouth and pharynx with Candida albicans reported with inhaled corticosteroids; treat with appropriate local or systemic (eg, oral) antifungal therapy while treatment continues; at times therapy may need to be interrupted
Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex; more serious or even fatal course of chickenpox or measles in susceptible patients; use caution because of potential for worsening of these infections; if exposed to chickenpox, prophylaxis with varicella-zoster immune globulin or pooled IV immunoglobulin may be indicated; if a patient is exposed to measles, prophylaxis with pooled IM immunoglobulin (IG) may be indicated
Caution when withdrawing from systemic corticosteroids and transferring to inhaled corticosteroids; taper systemic corticosteroids gradually and monitor for symptoms of HPA axis suppression and adrenal insufficiency; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy
Pregnancy and Lactation
Insufficient data on use in pregnant women
No information is available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production
Maximum Dosage
In general, corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease, route and product of administration, and on patient age and response. For some products maximum dosage limits have not been specified.
Topical: Twice daily application for cream/ointment; once daily application for lotion.
Intranasal: 110 mcg/day intranasally for fluticasone furoate (e.g., Flonase Sensimist); 200 mcg/day intranasally for fluticasone propionate (e.g., Flonase, Flonase Allergy); 744 mcg/day intranasally for fluticasone propionate for nasal polyps (Xhance).
Inhaler maximum dosages: 2,000 mcg/day via fluticasone propionate dry powder inhaler (DPI) (Flovent Diskus); 464 mcg/day via fluticasone propionate DPI (Armonair Digihaler); 200 mcg/day via fluticasone furoate DPI (Arnuity Ellipta); 1,760 mcg/day via fluticasone propionate MDI (Flovent HFA).
Topical: Twice daily application for cream/ointment; once daily application for lotion.
Intranasal: 110 mcg/day intranasally for fluticasone furoate (e.g., Flonase Sensimist); 200 mcg/day intranasally for fluticasone propionate (e.g., Flonase, Flonase Allergy); 744 mcg/day intranasally for fluticasone propionate for nasal polyps (Xhance).
Inhaler maximum dosages: 2,000 mcg/day via fluticasone propionate dry powder inhaler (DPI) (Flovent Diskus); 464 mcg/day via fluticasone propionate DPI (Armonair Digihaler); 200 mcg/day via fluticasone furoate DPI (Arnuity Ellipta); 1,760 mcg/day via fluticasone propionate MDI (Flovent HFA).
Topical: Twice daily application for cream/ointment; once daily application for lotion.
Intranasal: 110 mcg/day intranasally for fluticasone furoate (e.g., Flonase Sensimist); 200 mcg/day intranasally for fluticasone propionate (e.g., Flonase, Flonase Allergy). Safety and efficacy not established for fluticasone propionate for nasal polyps (Xhance).
Inhaler maximum dosages: 2,000 mcg/day via fluticasone propionate dry powder inhaler (DPI) (Flovent Diskus); 464 mcg/day via fluticasone propionate DPI (Armonair Digihaler); 200 mcg/day via fluticasone furoate DPI (Arnuity Ellipta); 1,760 mcg/day via fluticasone propionate MDI (Flovent HFA).
12 years:
Topical: Twice daily application for cream/ointment; once daily application for lotion.
Intranasal: 110 mcg/day intranasally for fluticasone furoate (e.g., Flonase Sensimist); 200 mcg/day intranasally for fluticasone propionate (e.g., Flonase, Flonase Allergy). Safety and efficacy not established for fluticasone propionate for nasal polyps (Xhance).
Inhaler maximum dosages: 2,000 mcg/day via fluticasone propionate dry powder inhaler (DPI) (Flovent Diskus); 464 mcg/day via fluticasone propionate DPI (Armonair Digihaler); 200 mcg/day via fluticasone furoate DPI (Arnuity Ellipta); 1,760 mcg/day via fluticasone propionate MDI (Flovent HFA).
5 to 11 years:
Topical: Twice daily application for cream/ointment; once daily application for lotion.
Intranasal: 55 mcg/day intranasally for fluticasone furoate (e.g., Flonase Sensimist); 200 mcg/day intranasally for fluticasone propionate (e.g., Flonase, Flonase Allergy). Safety and efficacy not established for fluticasone propionate for nasal polyps (Xhance).
Inhaler maximum dosages: 200 mcg/day via fluticasone propionate dry powder inhaler (DPI) (Flovent Diskus), however doses of up to 400 mcg/day off-label have been used for asthma; 176 mcg/day via fluticasone propionate MDI (Flovent HFA) per FDA-approved labeling, however, doses of 352 mcg/day or more have been used off-label for asthma; 50 mcg/day via fluticasone furoate DPI (Arnuity Ellipta); 110 mcg/day via fluticasone propionate DPI (Armonair Digihaler).
4 years:
Topical: Twice daily application for cream; once daily application for lotion.
Intranasal: 55 mcg/day intranasally for fluticasone furoate (e.g., Flonase Sensimist); 200 mcg/day intranasally for fluticasone propionate (e.g., Flonase, Flonase Allergy). Safety and efficacy not established for fluticasone propionate for nasal polyps (Xhance).
Inhaler maximum dosages: 200 mcg/day via fluticasone propionate dry powder inhaler (DPI) (Flovent Diskus); 176 mcg/day via fluticasone propionate MDI (Flovent HFA) per FDA-approved labeling, however, doses of 352 mcg/day or more have been used off-label for asthma; 110 mcg/day via fluticasone propionate DPI (Armonair Digihaler). Safety and efficacy of fluticasone furoate DPI (Arnuity Ellipta) have not been established.
2 to 3 years: Twice daily application for cream; once daily application for lotion; 55 mcg/day intranasally for fluticasone furoate (Flonase Sensimist). Fluticasone propionate MDI (Flovent HFA) has been used off-label in treatment of asthma. Safety and efficacy have not been established for other formulations.
1 year: Twice daily application for cream; once daily application for lotion. Fluticasone propionate MDI (Flovent HFA) has been used off-label in treatment of asthma. Safety and efficacy have not been established for other formulations.
3 months and older: Twice daily application for cream; once daily application for lotion. Safety and efficacy have not been established for other formulations.
1 to 2 months: Safety and efficacy have not been established.
Safety and efficacy have not been established.
