Asmanex
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.
Important Limitations of Use
ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm.
ASMANEX TWISTHALER is NOT indicated in children less than 4 years of age.
History
There is currently no drug history available for this drug.
Other Information
Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure:
Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons.
The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins).
Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).
Sources
Asmanex Manufacturers
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Physicians Total Care, Inc.
![Asmanex (Mometasone Furoate) Inhalant [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Asmanex | Physicians Total Care, Inc.
Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. Advise patients to rinse the mouth after inhalation. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.
2.1 Recommended Dosages in Patients 4 Years of Age and OlderThe recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.
TABLE 1: Recommended Dosages for ASMANEX TWISTHALER Treatment Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose * When administered once daily, ASMANEX TWISTHALER should be taken only in the evening. † The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily. ‡ For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [ see Warnings and Precautions (5.4)]. § Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy. Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening* 440 mcg† Patients ≥12 years who received inhaled corticosteroids 220 mcg once daily in the evening* 440 mcg† Patients ≥12 years who received oral corticosteroids‡ 440 mcg twice daily 880 mcg Children 4 – 11 years of age§ 110 mcg once daily in the evening* 110 mcg* -
Merck Sharp & Dohme Corp.
Asmanex | Merck Sharp & Dohme Corp.
Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. Advise patients to rinse the mouth after inhalation. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.
2.1 Recommended Dosages in Patients 4 Years of Age and OlderThe recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.
Table 1: Recommended Dosages for ASMANEX TWISTHALER Treatment Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose * When administered once daily, ASMANEX TWISTHALER should be taken only in the evening. † The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily. ‡ For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.5)]. § Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy. Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening* 440 mcg† Patients ≥12 years who received inhaled corticosteroids 220 mcg once daily in the evening* 440 mcg† Patients ≥12 years who received oral corticosteroids‡ 440 mcg twice daily 880 mcg Children 4-11 years of age§ 110 mcg once daily in the evening* 110 mcg*
![Asmanex (Mometasone Furoate) Inhalant [Merck Sharp & Dohme Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1ec2b62b-6bf5-4d70-8824-9d90e2d87a68&name=asmanex-09.jpg)
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