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Nasonex (Mometasone Furoate Nasal) - Summary

 
 



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 HIGHLIGHTS

Published Studies Related to Nasonex (Mometasone Nasal)

Effects of inhaled mometasone furoate on growth velocity and adrenal function: a placebo-controlled trial in children 4-9 years old with mild persistent asthma. [2011.10]
OBJECTIVE: To assess the effects of long-term mometasone furoate delivered via a dry powder inhaler (MF-DPI) on growth velocity and hypothalamic-pituitary-adrenal axis function in children with asthma... CONCLUSIONS: One year of treatment with a total daily dose of 100 mug of MF-DPI in the morning resulted in no significant difference, whereas a total daily dose of 200 mug of MF-DPI was associated with some changes in growth velocity when compared with placebo. The differences in growth velocity, and the absence of drug-related cortisol effects, support the use of a total daily dose of 100 mug of MF-DPI in children aged 4-9 years with mild persistent asthma.

Dysphagia and quality of life may improve with mometasone treatment in patients with eosinophilic esophagitis: a pilot study. [2011.10]
OBJECTIVE: The treatment of adult patients with eosinophilic esophagitis remains challenging. The aim was to assess dysphagia and health-related quality of life (HRQL) using validated scales and questionnaires before and after treatment with mometasone furoate... CONCLUSION: The dysphagia and impaired HRQL found in untreated patients with eosinophilic esophagitis improved significantly after 2 months of mometasone furoate treatment. A randomized placebo-controlled trial is warranted to assess causality. The scales and questionnaires used are sensitive instruments appropriate for symptom surveillance in individuals with eosinophilic esophagitis.

Application of mometasone spray to reduce sore throat after tracheal intubation. [2011.08]
CONCLUSION: Application of mometasone spray reduces postoperative sore throat after tracheal intubation.

The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. [2011.06]
BACKGROUND: The efficacy of oral montelukast in chronic asthma is well established. Montelukast is also an effective adjunctive therapy to inhaled corticosteroids (ICS) in asthma uncontrolled on ICS alone. Inhaled montelukast was recently shown to provide significant bronchodilation compared with placebo in patients with chronic asthma. The purpose of this study was to evaluate the efficacy of inhaled montelukast added to inhaled mometasone... CONCLUSION: Inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone in improving FEV(1), symptoms, asthma control, and blood eosinophil count.

Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. [2011.04.01]
CONCLUSION: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo. Copyright (c) 2011 Elsevier Inc. All rights reserved.

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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]).

Acute Effect of Mometasone Furoate DPI on Beta-adrenergic Airway and Airway Vascular Relaxation in Moderately Severe Asthma [Not yet recruiting]
Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation transporters expressed by non-neuronal cells, thereby interfering with the inactivation of the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations, and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor sites on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by the ICS' effect on the glucocorticosteroid-sensitive organic cation transporters. The investigators have shown in human airway vascular smooth muscle cells that the glucocorticosteroid action on organic cation uptake occurs within minutes, does not involve gene transcription or protein synthesis, is not mediated through classical steroid receptors, and is cell membrane-linked.

In the present proposal, the investigators wish to use different single doses of mometasone, a clinically effective ICS, administered with or at different times before albuterol inhalation in subjects with moderate persistent asthma who are obstructed at the time of study.

With this approach the investigators will test the hypothesis that a single inhalation of mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic bronchodilation.

If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic bronchodilation is correct, the results would have a significant impact on treatment strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.

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Reports of Suspected Nasonex (Mometasone Nasal) Side Effects

Drug Dose Omission (20)Product Quality Issue (16)Epistaxis (14)Dyspnoea (14)Cataract (14)NO Adverse Event (14)Malaise (13)Glaucoma (12)Headache (11)Drug Ineffective (9)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 12 ratings/reviews, Nasonex has an overall score of 7.92. The effectiveness score is 8.67 and the side effect score is 7.83. 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.

 

Nasonex review by 42 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   sinusitis
Dosage & duration:   Aqueous Nasal Spray 0.05% (dosage frequency: twice a day) for the period of 4 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Relieved symptoms of itchy runny nose providing relief from discomfort
Side effects:   None
Comments:   Use inhaler twice a day once in the morning and once in the evening for a period of four weeks. It took approximately five days to week before lasting relief was obtained. Continuous use prevented the condition from recurring. Condition occurred on a seasonal basis in the mid fall and mid spring period. No symptons in Winter or Summer.

 

Nasonex review by 64 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   swollen passages from allergies
Dosage & duration:   1puff in ea nostril ,2x daily (dosage frequency: 1 puff in ea nostril 2x dialy) for the period of two years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   drug helped alleviate stuffy feeling without much notice of any side effects.
Side effects:   in the past year i have been having reoccurring pink eye/blifuritis bouts. around the same tine i have been plagued with repeated episodes of itching, strange rashes all over my body and my hands are full of unsightly cracks,sores and redness. now the episodes are getting closer and closer and worse each time.
Comments:   topical and internal steroid meds and antibiotics to avert infection, all help just until the next outbreak which after the last bout was about a week or so.

See all Nasonex reviews / ratings >>

Page last updated: 2011-12-09

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