Fluticasone Furoate and Vilanterol 100 ug/1
fluticasone furoate and vilanterol · POWDER · Prasco Laboratories
Fluticasone Furoate and Vilanterol is a powder containing fluticasone furoate and vilanterol at 100 ug/1, taken respiratory (inhalation). Manufactured by Prasco Laboratories.
Key Facts
- Brand Name
- Fluticasone Furoate and Vilanterol
- Generic Name
- fluticasone furoate and vilanterol
- NDC Code (Product)
66993-135- Manufacturer
- Prasco Laboratories
- Strength
- 100 ug/1
- Dosage Form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA204275
- Marketing Start
- 05/23/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) • the maintenance treatment of asthma in patients aged 5 years and older. ( 1.2 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1.3 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older. 1.3 Limitations of Use Fluticasone Furoate/Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.3 ) • Maintenance treatment of COPD: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily administered by oral inhalation. ( 2.1 ) • Maintenance treatment of asthma in adult patients aged 18 years and older: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg or Fluticasone Furoate/Vilanterol ELLIPTA 200/25 mcg once daily administered by oral inhalation. ( 2.2 ) • Maintenance treatment of asthma in pediatric patients aged 12 to 17 years: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily administered by oral inhalation. ( 2.2 ) • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of fluticasone furoate/vilanterol ELLIPTA 50/25 mcg once daily administered by oral inhalation. ( 2.2 ) 2.1 Recommended Dosage for Maintenance Treatment of Chronic Obstructive Pulmonary Disease The recommended dosage of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg (containing fluticasone furoate 100 mcg and vilanterol 25 mcg) is 1 actuation once daily by oral inhalation. If shortness of breath occurs in the period between doses, an inhaled, short-a…
Contraindications
4 CONTRAINDICATIONS Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions ( 5.11 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins or any ingredients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects. ( 7.1 ) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on cardiovascular system. ( 7.2 ) • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.3 ) • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate and vilanterol are both substrates of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol. Caution should be exercised when considering the coadministration of Fluticasone Furoate/Vilanterol ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.9 ), Clinical Pharmacology ( 12.3 )] . 7.2 Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging D…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Serious Asthma-Related Events – Hospitalizations, Intubations, Death [see Warnings and Precautions ( 5.1 )] • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.4 )] • Pneumonia [see Warnings and Precautions ( 5.5 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.6 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.8 )] • Paradoxical Bronchospasm [see Warnings and Precautions ( 5.10 )] • Cardiovascular Effects [see Warnings and Precautions ( 5.12 )] • Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.13 )] • Growth Effects [see Warnings and Precautions ( 5.14 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.15 )] 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. • COPD: Most common adverse reactions (incidence ≥3%) are nasopharyngitis, upper respiratory tract inf…
Frequently Asked Questions
What is Fluticasone Furoate and Vilanterol used for?
Fluticasone Furoate and Vilanterol contains fluticasone furoate and vilanterol. It is a powder taken respiratory (inhalation). Consult your doctor for specific uses.
Is Fluticasone Furoate and Vilanterol a controlled substance?
Fluticasone Furoate and Vilanterol is not classified as a controlled substance by the DEA.
What is the generic name for Fluticasone Furoate and Vilanterol?
The generic name for Fluticasone Furoate and Vilanterol is fluticasone furoate and vilanterol. There are 3 other brand versions of fluticasone furoate and vilanterol.
What is the NDC code for Fluticasone Furoate and Vilanterol 100 ug/1?
The NDC (National Drug Code) for Fluticasone Furoate and Vilanterol 100 ug/1 is 66993-135, listed by Prasco Laboratories.