Drugplain

FLUTICASONE PROPIONATE DISKUS 250 ug/1

fluticasone propionate · POWDER, METERED · Prasco Laboratories

No Recall HistoryCurrently in Shortage
Plain English

Fluticasone Propionate Diskus is an inhaled corticosteroid used to control asthma and reduce airway inflammation in patients with persistent asthma. You inhale the powder directly into your lungs using the Diskus device as prescribed by your doctor.

Key Facts

Brand Name
FLUTICASONE PROPIONATE DISKUS
Generic Name
fluticasone propionate
NDC Code (Product)
66993-792
Manufacturer
Prasco Laboratories
Strength
250 ug/1
Dosage Form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA020833
Marketing Start
10/30/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea2,349 reports
drug ineffective2,307 reports
headache2,191 reports
fatigue2,062 reports
off label use1,832 reports
pain1,813 reports
nausea1,788 reports
cough1,666 reports
asthma1,610 reports
diarrhoea1,558 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Fluticasone Propionate DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use Fluticasone Propionate DISKUS is NOT indicated for the relief of acute bronchospasm. Fluticasone Propionate DISKUS is an inhaled corticosteroid (ICS) indicated for: • Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. ( 1 ) Important limitation: • Not indicated for relief of acute bronchospasm. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) • Treatment of asthma in patients aged 12 years and older: 100 mcg twice daily up to a maximum recommended dosage of 1,000 mcg twice daily. ( 2.2 ) • Treatment of asthma in patients aged 4 to 11 years: 50 mcg twice daily up to a maximum recommended dosage of 100 mcg twice daily. ( 2.2 ) 2.1 Administration Information Fluticasone Propionate DISKUS should be administered by the orally inhaled route in patients aged 4 years and older. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. 2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid (ICS) is 100 mcg twice daily, approximately 12 hours apart. For other patients, and for patients who do not r…

Contraindications

4 CONTRAINDICATIONS The use of Fluticasone Propionate DISKUS 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 propionate [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.2 ), Description ( 11 )] • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate DISKUS is not recommended because increased systemic corticosteroid adverse effects may occur. Ritonavir A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology ( 12.3 )] . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole Coadministration of orally inhaled fluticasone prop…

Adverse Reactions

6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions ( 5.1 )] • Immunosuppression [see Warnings and Precautions ( 5.3 )] • Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.5 )] • Reduction in bone mineral density [see Warnings and Precautions ( 5.7 )] • Growth effects [see Warnings and Precautions ( 5.8 )] • Glaucoma and cataracts [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence >3%) include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache. ( 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. The incidence of …

Frequently Asked Questions

What is FLUTICASONE PROPIONATE DISKUS used for?

Fluticasone Propionate Diskus is an inhaled corticosteroid used to control asthma and reduce airway inflammation in patients with persistent asthma. You inhale the powder directly into your lungs using the Diskus device as prescribed by your doctor.

Is FLUTICASONE PROPIONATE DISKUS a controlled substance?

FLUTICASONE PROPIONATE DISKUS is not classified as a controlled substance by the DEA.

What is the generic name for FLUTICASONE PROPIONATE DISKUS?

The generic name for FLUTICASONE PROPIONATE DISKUS is fluticasone propionate. There are 12 other brand versions of fluticasone propionate.

What is the NDC code for FLUTICASONE PROPIONATE DISKUS 250 ug/1?

The NDC (National Drug Code) for FLUTICASONE PROPIONATE DISKUS 250 ug/1 is 66993-792, listed by Prasco Laboratories.

Product NDC

66993-792

Package NDC

66993-792-97

Other Fluticasone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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