MOMETASONE SUMMARY
ELOCON® (mometasone furoate cream, USP) Cream 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.
ELOCON Cream 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
ELOCON (mometasone furoate cream, USP) Cream 0.1% may be used in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS - Pediatric Use section). Since safety and efficacy of ELOCON Cream 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.
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NEWS HIGHLIGHTS
Published Studies Related to Mometasone (Mometasone Topical)
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 Mometasone (Mometasone Topical)
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® 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.
Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers [Completed]
This study will compare the performance of three combination metered dose inhalation devices
and the variability of mometasone and formoterol doses delivered to the lungs in a healthy
volunteer population
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