fluticasone propionate - Medications

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: ■ nasal congestion ■ itchy nose ■ runny nose ■ itchy, watery eyes ■ sneezing

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Wixela Inhub ® 100/50, Wixela Inhub ® 250/50, and Wixela Inhub ® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub ® is fluticasone propionate, a corticosteroid having the chemical name S -Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure: Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub ® is salmeterol xinafoate, a beta 2 -adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α 1 -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]- m -xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure: Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C 25 H 37 NO 4 •C 11 H 8 O 3 . It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub ® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub ® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub ® 100/50, Wixela Inhub ® 250/50, and Wixela Inhub ® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2. Fluticasone Propionate Structural Formula Salmeterol Zinofoate Structural Formula

Wixela Inhub ® 100/50, Wixela Inhub ® 250/50, and Wixela Inhub ® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub ® is fluticasone propionate, a corticosteroid having the chemical name S -Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure: Fluticasone propionate, USP is a white to almost white powder with a molecular weight of 500.6, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of Wixela Inhub ® is salmeterol xinafoate, a beta 2 -adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name (±)-4-Hydroxy-α 1 -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]- m -xylene-α,α'-diol 1-hydroxy-2-naphthoate (salt) and the following chemical structure: Salmeterol xinafoate, USP is a white to almost white powder with a molecular weight of 603.8, and the empirical formula is C 25 H 37 NO 4 •C 11 H 8 O 3 . It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Wixela Inhub ® is a grey colored plastic inhaler containing two foil sealed discs, each disc containing 30 pre-metered doses. Each of the 60 doses contains a white to off white powder mix of micronized fluticasone propionate (100, 250, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Wixela Inhub ® delivers 93, 233, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per dose from Wixela Inhub ® 100/50, Wixela Inhub ® 250/50, and Wixela Inhub ® 500/50, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Meets USP Aerodynamic Particle Size Distribution Test 2.

The active component of XHANCE is fluticasone propionate, a corticosteroid, having the chemical name S -(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3oxoandrosta-1,4-diene-17β-carbothioate, 17‑propionate and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.57, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and dichloromethane, and slightly soluble in 96% ethanol. XHANCE (fluticasone propionate) nasal spray, 93 mcg, for nasal administration, with an Optinose exhalation delivery system that delivers an aqueous suspension of microfine fluticasone propionate having a particle size distribution in the range of 0 to 5 microns for topical nasal administration by means of a metering, atomizing spray pump and exhaled breath. XHANCE also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, benzalkonium chloride, polysorbate 80, edetate disodium dihydrate, sodium hydroxide and hydrochloric acid (to adjust pH), and purified water, and has a pH between 5 and 7. Before initial use, prime XHANCE by gently shaking and then pressing the amber glass bottle 7 times or until a fine mist appears. Once primed, XHANCE contains 120 metered sprays. When XHANCE has not been used for ≥ 7 days, prime again by releasing 2 sprays into the air, away from the face [see Dosage and Administration ( 2.2 ) and Instructions for Use ] . After priming, each spray delivers 93 mcg of fluticasone propionate in an aqueous suspension through the cone-shaped nosepiece. The system also has a flexible mouthpiece. Within the device is a non‑removable amber glass bottle with a metering spray pump, an applicator, and a valve that prevents release of breath until the bottle is pressed. A base covers the bottom of the bottle, and a removable orange cap covers both the nosepiece and mouthpiece. Chemical Structure

The active component of XHANCE is fluticasone propionate, a corticosteroid, having the chemical name S -(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3oxoandrosta-1,4-diene-17β-carbothioate, 17‑propionate and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.57, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and dichloromethane, and slightly soluble in 96% ethanol. XHANCE (fluticasone propionate) nasal spray, 93 mcg, for nasal administration, with an exhalation delivery system that delivers an aqueous suspension of microfine fluticasone propionate having a particle size distribution in the range of 0 to 5 microns for topical nasal administration by means of a metering, atomizing spray pump and exhaled breath. XHANCE also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, benzalkonium chloride, polysorbate 80, edetate disodium dihydrate, sodium hydroxide and hydrochloric acid (to adjust pH), and purified water, and has a pH between 5 and 7. Before initial use, prime XHANCE by gently shaking and then pressing the amber glass bottle 7 times or until a fine mist appears. When XHANCE has not been used for ≥ 7 days, prime again by releasing 2 sprays into the air, away from the face [see Dosage and Administration ( 2.2 ) and Instructions for Use ] . After priming, each spray delivers 93 mcg of fluticasone propionate in an aqueous suspension through the cone-shaped nosepiece. The system also has a flexible mouthpiece. Within the device is a non‑removable amber glass bottle with a metering spray pump, an applicator, and a valve that prevents release of breath until the bottle is pressed. A base covers the bottom of the bottle, and a removable orange cap covers both the nosepiece and mouthpiece. Chemical Structure