| Asmanex [mometasone furoate inhalation powder] |
| WHAT IS Asmanex? The Asmanex Twisthaler 220 mcg ( Mometasone furoate inhalation powder ) delivers anti-inflammatory medication for asthma through a dry powder delivery system. Asmanex is a cap-activated inhalation-driven multi-dose dry powder inhaler containing mometasone furoate and anhydrous lactose (which contains milk proteins). Each actuation of the Asmanex Twisthaler 220 mcg inhaler provides a measured dose of 1.5 mg mometasone furoate inhalation powder, containing 220 mcg of mometasone furoate.Asmanex(R) Twisthaler(R) 220mcg is for the first-line maintenance treatment of asthma as preventive therapy in patients 12 years of age and older. HOW DOES ASMANEX WORK? The active ingredient in Asmanex is mometasone furoate. Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. Inflammation is an important factor for asthma. The binding affinity of mometasone furoate for the human glucocorticoid receptor is about 12 times that of dexamethasone, 7 times that of triamcinolone acetonide and 5 times that of budesonide. Asmanex helps manage symptoms. Clinical studies with Asmanex have shown improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings and improvements in daytime symptoms such as coughing and wheezing. STATISTICS ABOUT ASMANEX Genetics, environment, and immune system factors can all contribute. Asthma triggers can include tobacco smoke and allergens such as dust mites, animal dander, and cockroaches. Currently, about 20 million people suffer from asthma. ASMANEX SIDE-EFFECTS The most common side effects of Asmanex include: headache, allergic rhinitis, pharyngitis, upper respiratory infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, dyspepsia, myalgia, abdominal pain, and nausea. RECENT CLINICAL FINDINGS ON ASMANEX (Mometasone furoate inhalation powder) BIOAVAILABILITY (ABSORPTION) Fluticasone propionate and mometasone furoate have similar and very low systemic bioavailability when administered intranasally using a high-dose regimen [of Asmanex]. [B1] Mometasone furoate (MF) and fluticasone propionate (FP) are high potency inhaled corticosteroids. The systemic bioavailability of MF is claimed to be negligible, leading to a minimal potential for systemic adverse effects. [B2] CONTRAINDICATIONS Asmanex Twisthaler therapy is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. SAFETY AND EFFECTIVENESS OF ASMANEX Mometasone furoate microemulsion is a safe and effective therapy in the treatment of symptomatic erosive-ulcerative oral lichen planus [B3]. Mometasone furoate does not affect mucociliary clearance in patients with perennial allergic rhinitis. [B4] Mometasone furoate DPI, 400 microg every evening, provided comparable efficacy as fluticasone propionate MDI, two 125-microg puffs twice daily, in subjects with moderate persistent asthma previously treated with fluticasone propionate. [B5] TASTE Compared with fluticasone propionate and mometasone furoate, triamcinolone acetonide aqueous was associated with significantly less odor, less taste, less dryness of nose/throat, less aftertaste, and greater overall liking. [B6] ABOUT ASTHMA As many as 20 million Americans have asthma, leading to 2 million emergeny room visits and more than 5000 deaths annually. [1] NEWS The FDA is planning to restrict use of Glaxo's Advair (another asthma treatment) as Advair may make some asthma episodes more severe and shouldn't be used as a first-choice treatment. Advair, a combo of Serevent and a steroid, is sold as Seretide in some markets. Thus, Merck's Singulair and Schering-Plough's Asmanex may takes its market share. [2] References for Asmanex Twisthaler : Once-Daily Asthma Medicine Approved, WebMD Medical News, March 31, 2005 - Asmanex Twisthaler Once-Daily Asthma Inhaler Approved Forbes.com. March 31, 2005 Product label, April 3, 2005 - Asmanex Twisthaler [1] Once-Daily Asthma Inhaler Approved, womenshealth.gov Online Publication, November 25, 2005. [2] Glaxo Shares Fall on U.S. Plan to Restrict Advair Use (Update 5) Bloomberg.com, Nov 21, 2005 S1 FDA Staff Recommends Updated Warning For Asmanex > SGP wsj.com JUNE 19, 2009, 10:18 A.M. ET [B1] Daley-Yates et al, Eur J Clin Pharmacol. 2004 Jun;60(4):265-8. Epub 2004 Apr 28 [B2] Fardon TC et al, Adrenal suppression with dry powder formulations of fluticasone propionate and mometasone furoate, Am J Respir Crit Care Med. 2004 Nov 1;170(9):960-6. Epub 2004 Jun 7. [B3] Aguirre JM, Efficacy of mometasone furoate microemulsion in the treatment of erosive-ulcerative oral lichen planus: pilot study. J Oral Pathol Med. 2004 Aug;33(7):381-5. [B4] Pata YS et al, The effect of mometasone furoate on mucociliary clearance in patients with perennial allergic rhinitis, Kulak Burun Bogaz Ihtis Derg. 2003 Oct;11(4):97-9.[B5] Wardlaw A Efficacy and safety of mometasone furoate dry powder inhaler vs fluticasone propionate metered-dose inhaler in asthma subjects previously using fluticasone propionate. Ann Allergy Asthma Immunol. 2004 Jul;93(1):49-55 [B6] Stokes M et al, Evaluation of patients' preferences for triamcinolone acetonide aqueous, fluticasone propionate, and mometasone furoate nasal sprays in patients with allergic rhinitis. Otolaryngol Head Neck Surg. 2004 Sep;131(3):225-31 |
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ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
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In a memo posted to FDA's Web site July 3, 2009, agency staff said a review of Asmanex
adverse event reports didn't identify events "unique to the pediatric population." However, FDA
staff recommended that the warnings section of Asmanex' label be expanded to discuss
"immediate hypersensitivity events", or allergic reactions. The memo noted that such a warning
is included for other asthma drugs including GlaxoSmithKline's (GSK) Advair and AstraZeneca's
(AZN) Symbicort. [S1]
adverse event reports didn't identify events "unique to the pediatric population." However, FDA
staff recommended that the warnings section of Asmanex' label be expanded to discuss
"immediate hypersensitivity events", or allergic reactions. The memo noted that such a warning
is included for other asthma drugs including GlaxoSmithKline's (GSK) Advair and AstraZeneca's
(AZN) Symbicort. [S1]