Fluticasone is a medicine sold in the U.S. under 13 brand and generic names, for perennial allergic rhinitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Arnuity Ellipta (application NDA205625). Other fluticasone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For oral inhalation only. ( 2.1 ) • Maintenance treatment of asthma in adult and pediatric patients aged 12 years and older: The starting dosage, 1 actuation of Fluticasone Furoate ELLIPTA 100 mcg or Fluticasone Furoate ELLIPTA 200 mcg once daily, is based on prior asthma therapy and disease severity. ( 2.2 ) • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of Fluticasone Furoate ELLIPTA 50 mcg once daily. ( 2.2 ) 2.1 Administration • Administer 1 actuation of Fluticasone Furoate ELLIPTA once daily by oral inhalation. • After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. • Fluticasone Furoate ELLIPTA should be used at the same time every day. Do not use Fluticasone Furoate ELLIPTA more than 1 time every 24 hours. • The maximum benefit may not be achieved for up to 2 weeks or longer after starting treatment. Individual patients may experience a variable time to onset and degree of symptom relief. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with mild hepatic impairment [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage Adult and Pediatric Patients Aged 12 Years and Older The recommended starting dosage for adult and pediatric patients aged 12 years and…
Systemic and local corticosteroid use may result in the following: • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] • Reduction in BMD [see Warnings and Precautions ( 5.9 )] • Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. ( 6.1 ) Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult and Pediatric Subjects Aged 12 Years and Older The safety of fluticasone furoate ELLIPTA was evaluated in 10 double-blind,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Spray/Inhaler | — | — | View → | |
| 2 | 72/100 | Over-the-counter | Spray/Inhaler | — | — |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Fluticasone Furoate ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions ( 5.8 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins ( 4 ) • Demonstrated hypersensitivity to any ingredients. ( 4 )
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when considering the coadministration of Fluticasone Furoate ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 )] .
| 3 | 70/100 | Prescription | Powder | — | — | View → |
| 4 | 70/100 | Prescription | Topical | — | — | View → |
| 5 | 70/100 | Prescription | Spray/Inhaler | — | — | View → |
| 6 | 46/100 | Prescription | Powder | — | — | View → |
| 7 | 46/100 | Prescription | Powder | — | — | View → |
| 8 | Not yet rated | Prescription | Powder | — | — | View → |
| 9 | Not yet rated | Prescription | Powder | — | — | View → |
| 10 | Not yet rated | Prescription | Powder | — | — | View → |