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fluticasone propionate
Overview
What is XHANCE?
The active component of XHANCE is fluticasone propionate, a corticosteroid, having the chemical name -(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 CHFOS. 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 intranasal 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 intranasal 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, 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 [].
After priming, each spray delivers 93 mcg of fluticasone propionate in 106 mg of 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 removable orange cap covers both the nosepiece and mouthpiece.
What does XHANCE look like?
What are the available doses of XHANCE?
Nasal spray: 93 mcg of fluticasone propionate in each 106-mg spray. ()
What should I talk to my health care provider before I take XHANCE?
How should I use XHANCE?
XHANCE™ nasal spray is indicated for the treatment of nasal polyps in patients 18 years of age or older.
Adults (18 years and older): The recommended dosage of XHANCE nasal spray is 1 spray (93 mcg of fluticasone propionate per spray) in each nostril twice daily (total daily dose, 372 mcg). A dose of 2 sprays (93 mcg of fluticasone propionate per spray) in each nostril twice daily may also be effective in some patients (total daily dose, 744 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril twice daily (total daily dose, 744 mcg).
Patients should use XHANCE at regular intervals since its effectiveness depends on regular use. Individual patients will experience a variable time to onset and different degrees of symptom relief.
The safety and efficacy of XHANCE when administered in excess of recommended doses have not been established.
What interacts with XHANCE?
Sorry No Records found
What are the warnings of XHANCE?
Sorry No Records found
What are the precautions of XHANCE?
Sorry No Records found
What are the side effects of XHANCE?
Sorry No records found
What should I look out for while using XHANCE?
XHANCE is contraindicated in patients with hypersensitivity to any of the ingredients [].
What might happen if I take too much XHANCE?
Chronic overdosage may result in signs/symptoms of hypercorticism []. An intranasal dose of 2 mg (2.7 to 5.4 times the recommended daily dose) of fluticasone propionate twice daily for 7 days was administered to healthy human volunteers. Adverse events reported with fluticasone propionate were similar to placebo, and no clinically significant abnormalities in laboratory safety tests were observed. Single oral doses up to 16 mg have been studied in human volunteers with no acute toxic effects reported. Oral inhalation by healthy volunteers of a single dose of 1.76 or 3.52 mg of fluticasone propionate was well tolerated. Fluticasone propionate given by pulmonary inhalation administration at dosages of 1.32 mg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.
How should I store and handle XHANCE?
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].XHANCE (fluticasone propionate) nasal spray is supplied as a non-removable amber glass bottle fitted with a metered-dose manual spray pump unit inside the white XHANCE device with a nasal applicator, valve mechanism, asymmetrical cone-shaped nosepiece, flexible mouthpiece, and orange cap in a box of 1 (NDC 71143-375-01) with FDA‑approved Patient Labeling [for proper use, see patient ].Each bottle contains a net fill content of 16 mL, and after priming will provide 120 metered sprays. Each metered spray delivers 93 mcg of fluticasone propionate in 106 mg of aqueous suspension through the cone‑shaped nosepiece. The correct amount of medication in each metered spray cannot be assured after 120 metered sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of metered sprays has been used.Store at room temperature (between 15°C and 25°C; 59°F and 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Avoid exposure to extreme heat, cold or light. Shake XHANCE before each use.XHANCE (fluticasone propionate) nasal spray is supplied as a non-removable amber glass bottle fitted with a metered-dose manual spray pump unit inside the white XHANCE device with a nasal applicator, valve mechanism, asymmetrical cone-shaped nosepiece, flexible mouthpiece, and orange cap in a box of 1 (NDC 71143-375-01) with FDA‑approved Patient Labeling [for proper use, see patient ].Each bottle contains a net fill content of 16 mL, and after priming will provide 120 metered sprays. Each metered spray delivers 93 mcg of fluticasone propionate in 106 mg of aqueous suspension through the cone‑shaped nosepiece. The correct amount of medication in each metered spray cannot be assured after 120 metered sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of metered sprays has been used.Store at room temperature (between 15°C and 25°C; 59°F and 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Avoid exposure to extreme heat, cold or light. Shake XHANCE before each use.XHANCE (fluticasone propionate) nasal spray is supplied as a non-removable amber glass bottle fitted with a metered-dose manual spray pump unit inside the white XHANCE device with a nasal applicator, valve mechanism, asymmetrical cone-shaped nosepiece, flexible mouthpiece, and orange cap in a box of 1 (NDC 71143-375-01) with FDA‑approved Patient Labeling [for proper use, see patient ].Each bottle contains a net fill content of 16 mL, and after priming will provide 120 metered sprays. Each metered spray delivers 93 mcg of fluticasone propionate in 106 mg of aqueous suspension through the cone‑shaped nosepiece. The correct amount of medication in each metered spray cannot be assured after 120 metered sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of metered sprays has been used.Store at room temperature (between 15°C and 25°C; 59°F and 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Avoid exposure to extreme heat, cold or light. Shake XHANCE before each use.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
The precise mechanism through which fluticasone propionate affects nasal polyps and associated inflammatory symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. The anti-inflammatory action of corticosteroids contributes to their efficacy. In 7 trials in adults, fluticasone propionate nasal spray decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo). In addition, studies suggest that carbon dioxide, which is present in the exhaled breath delivered into the nose through the device, may influence inflammatory mediator activity and neuropeptide activity, possibly through mechanisms of action that also include removal of nitric oxide, change in pH, or positive pressure. The direct relationship of these findings to long-term symptom relief is not known.
Non-Clinical Toxicology
XHANCE is contraindicated in patients with hypersensitivity to any of the ingredients [].The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
Epistaxis, Nasal Erosions and Ulcerations
In placebo-controlled clinical trials of 16 weeks duration, epistaxis, nasal erosions, and nasal ulcerations were reported more frequently in patients treated with XHANCE than those who received placebo [].
Nasal Septal Perforation
Nasal septal perforations have been reported in patients following the intranasal application of XHANCE. In placebo-controlled clinical trials of 16 weeks duration, nasal septal perforations were reported in 1 (0.3%) patient treated with XHANCE compared with none treated with placebo. The patient had a prior history of nasal/sinus surgery. Three (0.3%) patients treated with XHANCE in uncontrolled, open-label trials of 3 to 12 months duration developed nasal septal perforations.
As with any long term topical treatment of the nasal cavity, patients using XHANCE over several months or longer should be examined periodically for possible changes in the nasal mucosa. If a septal perforation is noted, discontinue XHANCE. Avoid spraying XHANCE directly on the septum.
Candida
In clinical trials with XHANCE, localized infections with have been observed. Eight (0.9%) patients in uncontrolled, open-label trials of 3 to 12 months duration developed infections (nasal, pharyngeal, esophageal or intestinal). If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of XHANCE. Patients using XHANCE should be examined periodically for evidence of infection in the nasal and oropharyngeal mucosa.
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should avoid using XHANCE until healing has occurred.
Systemic and local corticosteroid use may result in the following:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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