Flonase (Fluticasone Propionate Nasal) - Summary

FLONASE SUMMARY

FLONASE®
(fluticasone propionate)
Nasal Spray, 50 mcg

For Intranasal Use Only. SHAKE GENTLY BEFORE USE.

Fluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6(alpha),9-difluoro-11(beta)-17-dihydroxy -16(alpha)-methyl-3-oxoandrosta-1,4-diene-17(beta)-carbothioate, 17-propionate.

FLONASE Nasal Spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older.

Safety and effectiveness of FLONASE Nasal Spray in children below 4 years of age have not been adequately established.

See all Flonase indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Flonase (Fluticasone Nasal)

Immunotherapy Effective in Pediatric Asthma and Rhinitis
Source: Medscape Allergy & Clinical Immunology Headlines [2013.05.13]
Subcutaneous and sublingual immunotherapy are both helpful for kids with asthma and rhinitis - and the sublingual approach has some advantages, although it doesn't have regulatory approval.
Reuters Health Information

Review Article Examines Sublingual Immunotherapy For Treatment Of Allergic Rhinitis And Asthma
Source: Allergy News From Medical News Today [2013.03.28]
In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by the U.S. Food and Drug Administration, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to an article in the March 27 issue of JAMA...

Chronic Rhinitis and Post-Nasal Drip
Source: MedicineNet Rhinoplasty Specialty [2008.07.21]
Title: Chronic Rhinitis and Post-Nasal Drip
Category: Diseases and Conditions
Created: 7/13/1998 12:00:00 AM
Last Editorial Review: 7/21/2008 12:00:00 AM

News From The Annals Of Internal Medicine: Feb. 19, 2013
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2013.02.20]
1. Acupuncture May be an Effective Alternative for Treating Seasonal Allergies Patients receiving acupuncture treatments for seasonal allergic rhinitis reported statistically significant improvements in symptoms and decreased use of medication compared to patients having standard treatment or sham acupuncture, but the clinical significance of the observed improvements is uncertain...

more news >>

Published Studies Related to Flonase (Fluticasone Nasal)

MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. [2012]
Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR)...

Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial. [2011.10.06]
ABSTRACT: BACKGROUND: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma... CONCLUSIONS: FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma. TRIAL REGISTRATION: NCT00398645.

Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. [2011.09]
BACKGROUND: COPD is associated with increased arterial stiffness which may in part explain the cardiovascular morbidity observed in the disease. A causal relationship between arterial stiffness and cardiovascular events has not been established, though their strong association raises the possibility that therapies that reduce arterial stiffness may improve cardiovascular outcomes. Prior studies suggest that fluticasone propionate/salmeterol (FSC) may improve cardiovascular outcomes in COPD and we hypothesized that FSC would reduce arterial stiffness in these patients... CONCLUSION: FSC does not reduce aPWV in all patients with moderate to severe COPD, but may have effects in those with elevated arterial stiffness. Additional studies are required to determine if aPWV could serve as a surrogate for cardiovascular events in COPD. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

[Cost effectiveness of treatment with salmeterol/fluticasone compared to montelukast for the control of persistent asthma in children]. [2011.07]
OBJECTIVE: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children... CONCLUSIONS: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Long-term monotherapy with suplatast tosilate in patients with mild atopic asthma: a pilot comparison with low-dose inhaled fluticasone. [2011.06]
BACKGROUND AND OBJECTIVE: Suplatast tosilate is a Th2 cytokine inhibitor that is effective for controlling persistent asthma. However, the long-term efficacy of suplatast is unknown. We compared the clinical efficacy of long-term monotherapy with suplatast tosilate with a low dose of inhaled steroids in patients with mild atopic asthma... CONCLUSIONS: Long-term treatment with suplatast significantly improved symptoms and inflammatory indices in patients with mild atopic asthma. Along with fluticasone, suplatast is considered a useful drug for the management of mild atopic asthma.

more studies >>

Clinical Trials Related to Flonase (Fluticasone Nasal)

A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 Mcg Twice Daily In Symptomatic Patients With Asthma [Active, not recruiting]
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 Mcg BID In Symptomatic Subjects With Asthma [Active, not recruiting]
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays [Recruiting]
The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i. e. FLU alone in the MP29-02 vehicle; REF).

The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product, Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics [Recruiting]
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics [Completed]
A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.

more trials >>

Reports of Suspected Flonase (Fluticasone Nasal) Side Effects

Drug Ineffective (24),  Epistaxis (12),  Nasal Discomfort (8),  Headache (8),  Tendonitis (7),  Pneumonia (7),  Back Pain (6),  Plantar Fasciitis (6),  Peripheral Coldness (5),  Palmar Fasciitis (5), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Flonase review by 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		allergies
Dosage & duration:		2 sprays in each nostril (dosage frequency: as needed) for the period of still taking it
Other conditions:		Mostly sinus pressure
Other drugs taken:		Claratin
		Reported Results
Benefits:		This spray clears the nasal passages to promote free breathing. I've tried over the counter remedies but they are harsh and you end up practically addicted to them. This works much the same way but is non-addictive and need only be used when symptoms hit. I have used this same product when I've had a head cold and achieved the same results. I'm pretty sure that's not what it's intended for but whenever I've got sinus pressure, I take this product.
Side effects:		I've experienced no side effects.
Comments:		Simply shake the bottle, and use 2 sprays in each nostril daily.

Flonase review by 30 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		sinus allergy
Dosage & duration:		2 sprays daily (dosage frequency: daily) for the period of 2 weeks
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Relief for my nasal clogging and breaht normally. Works great!
Side effects:		I've experienced no side effects, although there was some mild headache during the first day of use- this could have been due to other reasons.
Comments:		Moved to a new area with a lot of trees / greenry and experiecing temporary allergies while there. got prescribed flonase with dosage described above, and felt much better.

Flonase review by 20 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		allergies
Dosage & duration:		50 mcg twice per nostril (dosage frequency: once a day) for the period of 2 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Effective inrelieving runny or clogged nose due to allergies, stops itchy,swelling and watering eyes.
Side effects:		Only lasted for 8 hours max, I was given specific instructions not to use more than once a day, so I still had to rely on over-the-counter pills after the 8 hours were up. Caused asthma in cold, dry weather and a very, very scratchy throat, as in physically having to scratch at my throat to relieve it. Worsened a pre-existing eczema condition.
Comments:		Used 2 pumps per nostril, once a day to relieve everyday allergies.