Fluticasone Propionate

What it is and how it works

Mechanism of Action Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown. Inflammation is an important component in the pathogenesis of asthma.

Indications

Fluticasone propionate inhalation aerosol 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 inhalation aerosol is not indicated for the relief of acute bronchospasm. Fluticasone propionate inhalation aerosol is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of use: Not indicated for relief of acute bronchospasm.

Dosage and administration (summary)

• For oral inhalation only. • Starting dosage is based on prior asthma therapy and disease severity. • Adult and adolescent patients aged 12 years and older: 88 mcg twice daily up to a maximum dosage of 880 mcg twice daily. • Pediatric patients aged 4 to 11 years: 88 mcg twice daily. Administration Information Fluticasone propionate inhalation aerosol 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 inhalation aerosol to young patients.

Contraindications

Fluticasone propionate inhalation aerosol is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required . • Hypersensitivity to any of the ingredients . • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. • Hypersensitivity to any ingredient.

Warnings and precautions

• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. • Risk of impaired adrenal function when transferring from systemic corticosteroids.

Pregnancy

Pregnancy Risk Summary There are insufficient data on the use of fluticasone propionate inhalation aerosol in pregnant women. There are clinical considerations with the use of fluticasone propionate inhalation aerosol in pregnant women.

Storage and supply

Fluticasone Propionate Inhalation Aerosol USP is supplied in the following box of 1 as a pressurized aluminum canister with a white plastic actuator with a dose counter and maroon cap: • Fluticasone Propionate Inhalation Aerosol USP, 44 mcg: 10.6-g canister containing 120 actuations (NDC 68462-937-20).

Source: Fluticasone Propionate (Fluticasone Propionate) — US FDA prescribing information, 2026-03-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.