Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older. Fluticasone Nasal Spray Dosage and AdministrationAdminister fluticasone propionate nasal spray by the intranasal route only. Prime fluticasone propionate nasal spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake fluticasone propionate nasal spray gently before each use.Patients should use fluticasone propionate nasal spray at regular intervals since its effectiveness depends on its regular use.
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Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief. AdultsThe recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg).
The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. And 8 p.m.) is also effective.
After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective. Adolescents and Children (Aged 4 Years and Older)The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). Once adequate control is achieved, the dosage should be decreased to 1 spray in each nostril once daily.The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).
There is no evidence that exceeding the recommended dose is more effective. Dosage Forms and StrengthsFluticasone propionate nasal spray USP is an aqueous suspension. Each 100 mg spray delivers 50 mcg of fluticasone propionate USP. ContraindicationsFluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients,.
Warnings and Precautions Local Nasal EffectsEpistaxis: In clinical trials of 2 to 26 weeks’ duration, epistaxis was observed more frequently in subjects treated with fluticasone propionate nasal spray than those who received placebo.Nasal Ulceration: Postmarketing cases of nasal ulceration have been reported in patients treated with fluticasone propionate nasal spray.Candida Infection: In clinical trials with fluticasone propionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of fluticasone propionate nasal spray. Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6 and the molecular formula is C 25H 31F 3O 5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.Fluticasone propionate nasal spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone propionate nasal spray also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol and polysorbate 80 and has a pH between 5 and 7.After initial priming, each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Fluticasone Nasal Spray - Clinical Pharmacology Mechanism of ActionFluticasone 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 rhinitis 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. In 7 trials in adults, fluticasone propionate nasal spray has decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo).
The direct relationship of these findings to long-term symptom relief is not known. PharmacodynamicsHPA Axis Effect: The potential systemic effects of fluticasone propionate nasal spray on the HPA axis were evaluated.
Fluticasone propionate nasal spray given as 200 mcg once daily or 400 mcg twice daily was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. Fluticasone propionate nasal spray at either dosage for 4 weeks did not affect the adrenal response to 6-hour cosyntropin stimulation, while both dosages of oral prednisone significantly reduced the response to cosyntropin.Cardiac Electrophysiology: A study specifically designed to evaluate the effect of fluticasone propionate nasal spray on the QT interval has not been conducted.
PharmacokineticsThe activity of fluticasone propionate nasal spray is due to the parent drug, fluticasone propionate. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration.Absorption: Indirect calculations indicate that fluticasone propionate delivered by the intranasal route has an absolute bioavailability averaging less than 2%. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (.
Figure 5Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. Before you throw the bottle away, you should talk to your healthcare provider to see if a refill is needed.
Do not take extra doses or stop taking fluticasone propionate nasal spray without talking to your healthcare provider.Cleaning your fluticasone propionate nasal spray:Your nasal spray should be cleaned at least 1 time each week.1. Remove the dust cap and then gently pull upwards to free the nasal applicator.2. Wash the applicator and dust cap under warm tap water. Allow to dry at room temperature.3. Place the applicator and dust cap back on the bottle.4. If the nasal applicator becomes blocked, it can be removed and left to soak in warm water.
Rinse the nasal applicator with cold tap water. Dry the nasal applicator and place it back on the bottle. Do not try to unblock the nasal applicator by inserting a pin or other sharp object.Storing your fluticasone propionate nasal spray:. Store between 39° and 86°F (4° and 30°C). Do not use your fluticasone propionate nasal spray after the date shown as “EXP” on the label or box.This Patient Information and Instructions for Use has been approved by the U.S.
Food and Drug Administration.Distr. By: West-WardPharmaceuticals Corp.Eatontown, NJ 064/09Revised January 2019 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL.