NASONEX SUMMARY
Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11(beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2 furoate) monohydrate, and the following chemical structure:
NASONEX Nasal Spray, 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. NASONEX Nasal Spray, 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older. In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation of prophylaxis with NASONEX Nasal Spray, 50 mcg is recommended 2 to 4 weeks prior to the anticipated start of the pollen season. Safety and effectiveness of NASONEX Nasal Spray, 50 mcg in pediatric patients less than 2 years of age have not been established.
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NEWS HIGHLIGHTSMedia Articles Related to Nasonex (Mometasone Nasal)
Treatment Of Allergic Rhinitis Improves Coexisting Diseases
Source: Allergy News From Medical News Today [2009.11.09]
The treatment of allergic rhinitis is shown to improve co-existing conditions including conjunctivitis, asthma, sinusitis, otitis media with effusion (fluid in the middle ear) and sleep disorders according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.
Allergy drug tackles nasal congestion: study (Reuters)
Source: Y! Health Allergy News [2009.11.12]
Reuters - The "second generation" allergy drug desloratadine (brand name Clarinex) significantly reduces both the runny nose and congestion of seasonal and persistent allergic rhinitis, a study shows.
ACAAI: Drug Combo Effective in Allergic Eye Symptoms (CME/CE)
Source: MedPage Today Allergy & Immunology [2009.11.11]
MIAMI BEACH (MedPage Today) -- A combination of two standard drugs delivered together was safe and effective in treating the itchy and watery eyes associated with seasonal allergic rhinitis, a researcher said.
Published Studies Related to Nasonex (Mometasone Nasal)
Once-Daily Evening Dosing of Mometasone Furoate Administered Via a Dry Powder Inhaler Does Not Adversely Affect the Hypothalamic-Pituitary-Adrenal Axis. [2009.09.14]
BACKGROUND: Inhaled corticosteroids can suppress the hypothalamic-pituitary-adrenal (HPA) axis with long-term exposure. This study reports the effects of moderate-dose (400 mug) mometasone furoate administered via dry powder inhaler (MF-DPI) once daily in the evening on the HPA axis in adults with mild to moderate asthma... CONCLUSIONS: Once-evening moderate dosing (400 mug) MF-DPI does not suppress HPA- axis function in adults with mild to moderate asthma.
Mometasone furoate 0.1% and salicylic acid 5% vs. mometasone furoate 0.1% as sequential local therapy in psoriasis vulgaris. [2009.08]
BACKGROUND AND OBJECTIV:E Treatment in psoriasis vulgaris continues to unmet needs in terms of efficacy, quality of life and costs. Patients with moderate forms of psoriasis are using topical corticosteroids as first-line therapy and patients with severe forms also use this therapy. Optimization of this treatment is made by the use of combination drugs or by the sequential or rotational therapies. A multicentric clinical study was performed to measure the efficiency of mometasone furoate 0.1% and salicylic acid 5% and mometasone furoate 0.1% as sequential local therapy in psoriasis... CONCLUSION: The sequential treatment mometasone furoate 0.1% and salicylic acid 5% followed by mometasone furoate 0.1% proves to be efficient, safe and an excellent option for the following sequence: in-patient and out-patient.
Effect of the inhaled corticosteroid mometasone on small airway patency in patients with asthma. [2009.05]
The inflammation in asthma involves both the large and the small airways. This study was designed to examine whether mometasone delivered from a dry powder inhaler would improve those parameters thought to reflect patency and obstruction of the small airways (diameter <2 mm)... Mometasone delivered by a dry powder inhaler improved asthma control and pulmonary function in tests reflecting both large and small airways.
Mometasone furoate nasal spray is safe and effective for 1-year treatment of children with perennial allergic rhinitis. [2009.05]
OBJECTIVE: Perennial allergic rhinitis (PAR) affects children at a young age. Current guidelines recommend intranasal corticosteroids as the first-line treatment in patients with moderate-to-severe or persistent disease or in those who have congestion. In this study, the long-term safety and efficacy of mometasone furoate nasal spray (MFNS) were assessed in children with PAR... CONCLUSIONS: Treatment with MFNS 100 microg once daily for 1 year was well tolerated in children 6-11 years old, with negligible systemic exposure and no evidence of suppression of the hypothalamic-pituitary-adrenal axis or ocular changes.
Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. [2009.03]
OBJECTIVE: To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS)... CONCLUSIONS: Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00731185.
Clinical Trials Related to Nasonex (Mometasone Nasal)
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between the Ages of 6 and Less Than 18 Years Old (Study P04292AM1) [Active, not recruiting]
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (MFNS) in the
treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years
old. Safety will be the primary focus of this study.
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) [Completed]
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy
of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice
daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind
treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during
the run-in period. Efficacy will be measured by mean area under curve (AUC) of the change
from Baseline to Week 12 in FEV1.
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1) [Active, not recruiting]
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,
parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate
(MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind
Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to
3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to
Week 12 in area under the forced expiratory volume in one second concentration time curve
from 0 to 12 hours (FEV1 AUC[0-12 hr]).
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1) [Active, not recruiting]
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,
parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate
(MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind
Treatment Period, subjects will receive open-label MF MDI 100 mcg twice daily (BID) for 2 to
3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to
Week 12 in area under the forced expiratory volume in one second concentration time curve
from 0 to 12 hours (FEV1 AUC[0-12 hr]).
Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED) [Terminated]
This study will hope to show that the treatment of the patient's perennial allergic rhinitis
(PAR) using Nasonex® (mometasone furoate nasal spray) will result in improvement of the nasal
symptoms of PAR and of nighttime sleep-disordered breathing, thereby resulting in improved
sleep quality, less daytime sleepiness, improved daytime functioning, and improved quality of
life.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Nasonex has an overall score of 8.50. The effectiveness score is 8.67 and the side effect score is 8.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Nasonex review by 41 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | congestion |
| Dosage & duration: | | 2 sprays 2 times a day (dosage frequency: 2times every day) for the period of 6 months |
| Other conditions: | | sneezing |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Able to breath at night, less sneezing. I woke up with less nasal stufiness and felt clear headed. I also appreciated the moisturizing glycerin in Nasonex. I have a extremely dry nasal mucosa so there was definitely a benefit to that. |
| Side effects: | | Did not have any side effects and I felt extremely good during the allergy season. I actually enjoyed the moisterizing glycerin in my nose. |
| Comments: | | Use in the morning and evening in the spring allergy season. Continue to use even if symptoms disapear and 2 to 4 weeks prior to full blown allergy symptoms. |
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| | Nasonex review by 41 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | congested sinuses |
| Dosage & duration: | | metered spray (dosage frequency: 2 sprays per nostril, 2 times per day) for the period of 1 year |
| Other conditions: | | none |
| Other drugs taken: | | decongestants | | |
Reported Results |
| Benefits: | | Traeatment with Nasonex was effective at controlling some of my congestion before sinus surgery and all of it after surgery. The treatment also controlled my allergies to cats and dogs as a bonus! I stayed 4 days at a freinds house with a dog and was without sneezing and stuffiness, however my asthma was still an issue. |
| Side effects: | | Immediate side effects that I noticed were with my immune system. I got sick (colds and upper respiratory infections) more easily and I had one bug bite that became infected and took a long time to heal. I also noticed that I put on a few pounds (2-3) but am not sure if that is related or not. |
| Comments: | | Began treatment with spray before sinus surgery and continued after surgery. 6 months after surgery, the spray was stopped. |
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| | Nasonex review by 49 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | sinus polyps |
| Dosage & duration: | | 2 sprays each nostril (dosage frequency: twice daily) for the period of 3+ years |
| Other conditions: | | asthma |
| Other drugs taken: | | Flovent, Allegra-D | | |
Reported Results |
| Benefits: | | After polypectomy, kept polyps from reforming to a large degree though I've never regained my sense of smell except for periodic whiffs of gasoline, etc. |
| Side effects: | | I had no reportable side effects though I might sneeze a couple of times after treatment and sometimes have mild sinus drainage, I assume of the drug itself. |
| Comments: | | Treatment is simple. I only spray in nostrils twice a day. |
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Page last updated: 2009-11-12
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