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ASMANEX

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Overview

What is ASMANEX?

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 CHClO, 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 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 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).



What does ASMANEX look like?



What are the available doses of ASMANEX?

ASMANEX TWISTHALER is a dry powder for inhalation that is available in 2 strengths.

ASMANEX TWISTHALER 220 mcg delivers 200 mcg mometasone furoate per actuation from the mouthpiece.

ASMANEX TWISTHALER 110 mcg delivers 100 mcg mometasone furoate per actuation from the mouthpiece.

What should I talk to my health care provider before I take ASMANEX?

How should I use ASMANEX?

ASMANEX TWISTHALER is a corticosteroid indicated for:

ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm (, ) or in children less than 4 years of age (, ).

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.


What interacts with ASMANEX?

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What are the warnings of ASMANEX?

Sorry No Records found


What are the precautions of ASMANEX?

Sorry No Records found


What are the side effects of ASMANEX?

Sorry No records found


What should I look out for while using ASMANEX?

Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. ()

Patients with a hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER. ()


What might happen if I take too much ASMANEX?

Chronic overdosage may result in signs/symptoms of hypercorticismBecause of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies, acute overdose is unlikely to require any treatment other than observation. Single daily doses as high as 1200 mcg per day for 28 days were well tolerated and did not cause a significant reduction in plasma cortisol AUC (94% of placebo AUC). Single oral doses up to 8000 mcg have been studied on human volunteers with no adverse reactions reported.


How should I store and handle ASMANEX?

Topiramate extended-release capsules should be stored in well-closed containers at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from moisture and light.Topiramate extended-release capsules should be stored in well-closed containers at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from moisture and light.The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER 110 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER product is available as:ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01).ASMANEX TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02).Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER 110 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER product is available as:ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01).ASMANEX TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02).Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER 110 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER product is available as:ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01).ASMANEX TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02).Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER 110 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER product is available as:ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01).ASMANEX TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02).Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER 110 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER product is available as:ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01).ASMANEX TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02).Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER 110 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is gray with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").The ASMANEX TWISTHALER product is available as:ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece: 14 inhalation units (Institutional Use Only; NDC# 0085-1341-06); 30 inhalation units (NDC# 0085-1341-07); 60 inhalation units (for more than 1 inhalation daily; NDC# 0085-1341-02); or 120 inhalation units (for more than 2 inhalations daily; NDC# 0085-1341-01).ASMANEX TWISTHALER 110 mcg, which delivers 100 mcg mometasone furoate from the mouthpiece: 7 inhalation units (Institutional Use Only; NDC# 0085-1461-07); 30 inhalation units (NDC# 0085-1461-02).Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation and in the asthmatic response. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Mometasone furoate has been shown to exhibit a binding affinity for the human glucocorticoid receptor, which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. The clinical significance of these findings is unknown.

Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Non-Clinical Toxicology
Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. ()

Patients with a hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER. ()

Apraclonidine should not be used in patients receiving MAO inhibitors (see ). Although no specific drug interactions with topical glaucoma drugs or systemic medications were identified in clinical studies of apraclonidine ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, anesthetics) should be considered. Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with apraclonidine can lead to a reduction in IOP lowering effect. No data on the level of circulating catecholamines after apraclonidine withdrawal are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

An additive hypotensive effect has been reported with the combination of systemic clonidine and neuroleptic therapy. Systemic clonidine may inhibit the production of catecholamines in response to insulin-induced hypoglycemia and mask the signs and symptoms of hypoglycemia.

Since apraclonidine may reduce pulse and blood pressure, caution in using drugs such as beta-blockers (ophthalmic and systemic), antihypertensives, and cardiac glycosides is advised. Patients using cardiovascular drugs concurrently with apraclonidine ophthalmic solution should have pulse and blood pressure frequently monitored. Caution should be exercised with simultaneous use of clonidine and other similar pharmacologic agents.

In clinical trials, the development of localized infections of the mouth and pharynx with occurred in 195 of 3007 patients treated with ASMANEX TWISTHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX TWISTHALER therapy, but at times therapy with the ASMANEX TWISTHALER may need to be interrupted. Advise patients to rinse the mouth after inhalation of ASMANEX TWISTHALER.

Systemic and local corticosteroid use may result in the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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