Fluticasone Propionate HFA 44 ug/1

fluticasone propionate · AEROSOL, METERED · A-S Medication Solutions

No Recall HistoryCurrently in Shortage

Plain English

Fluticasone propionate is an inhaled corticosteroid used to control and prevent asthma symptoms. You inhale this medication through your mouth using a metered-dose aerosol inhaler.

Key Facts

Brand Name: Fluticasone Propionate HFA
Generic Name: fluticasone propionate
NDC Code (Product): 50090-6053
Manufacturer: A-S Medication Solutions
Strength: 44 ug/1
Dosage Form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA021433
Marketing Start: 05/23/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea2,355 reports

drug ineffective2,313 reports

headache2,199 reports

fatigue2,071 reports

off label use1,836 reports

pain1,823 reports

nausea1,796 reports

cough1,674 reports

asthma1,621 reports

diarrhoea1,567 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate HFA is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. ( 1 ) Limitations of use: 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 ) • Adult and adolescent patients aged 12 years and older: 88 mcg twice daily up to a maximum dosage of 880 mcg twice daily. ( 2.2 ) • Pediatric patients aged 4 to 11 years: 88 mcg twice daily. ( 2.2 ) 2.1 Administration Information Fluticasone Propionate HFA should be administered by the orally inhaled route only. After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. A valved holding chamber and mask may be used to deliver Fluticasone Propionate HFA to young patients. Priming Prime Fluticasone Propionate HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face. Avoid spraying in eyes. 2.2 Recommended Dosage Adult and Adolescent Patients Aged 12 Years and Older The recommended starting dosage for patients…

Contraindications

4 CONTRAINDICATIONS Fluticasone Propionate HFA 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 )] . • Hypersensitivity to any of the ingredients [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 ) • Hypersensitivity to any ingredient. ( 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 HFA 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 propion…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Oropharyngeal candidiasis infection [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 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%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, 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 comm…

Frequently Asked Questions

What is Fluticasone Propionate HFA used for?

Fluticasone propionate is an inhaled corticosteroid used to control and prevent asthma symptoms. You inhale this medication through your mouth using a metered-dose aerosol inhaler.

Is Fluticasone Propionate HFA a controlled substance?

Fluticasone Propionate HFA is not classified as a controlled substance by the DEA.

What is the generic name for Fluticasone Propionate HFA?

The generic name for Fluticasone Propionate HFA is fluticasone propionate. There are 12 other brand versions of fluticasone propionate.

What is the NDC code for Fluticasone Propionate HFA 44 ug/1?

The NDC (National Drug Code) for Fluticasone Propionate HFA 44 ug/1 is 50090-6053, listed by A-S Medication Solutions.

Product NDC

50090-6053

Package NDC

50090-6053-0

Other Fluticasone Brands

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