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ASMANEX HFA
Overview
What is ASMANEX HFA?
ASMANEX HFA is a metered dose inhaler for oral inhalation only, consisting of 100 mcg and 200 mcg of mometasone furoate per actuation.
Mometasone furoate, the active component of ASMANEX HFA, is a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure:
Mometasone furoate is a white powder with an empirical formula of CHClO, and molecular weight 521.44. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone.
Each ASMANEX HFA 100 mcg and 200 mcg is a hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane) propelled pressurized metered dose inhaler containing sufficient amount of drug for 120 actuations . After priming, each actuation of the inhaler delivers 115 or 225 mcg of mometasone furoate in 69.6 mg of suspension from the valve and delivers 100 or 200 mcg of mometasone furoate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. ASMANEX HFA also contains ethanol as a cosolvent and oleic acid as a surfactant.
ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.
What does ASMANEX HFA look like?
What are the available doses of ASMANEX HFA?
ASMANEX HFA is a pressurized metered dose inhaler that is available in 2 strengths.
ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation.
ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation.
What should I talk to my health care provider before I take ASMANEX HFA?
How should I use ASMANEX HFA?
ASMANEX HFA is a corticosteroid indicated for:
Important limitations:
ASMANEX HFA should be administered only by the orally inhaled route . After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.
The cap from the mouthpiece of the actuator should be removed before using ASMANEX HFA.
ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.
The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.
What interacts with ASMANEX HFA?
Sorry No Records found
What are the warnings of ASMANEX HFA?
Sorry No Records found
What are the precautions of ASMANEX HFA?
Sorry No Records found
What are the side effects of ASMANEX HFA?
Sorry No records found
What should I look out for while using ASMANEX HFA?
Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ()
Hypersensitivity to any of the ingredients of ASMANEX HFA. ()
What might happen if I take too much ASMANEX HFA?
Chronic overdosage may result in signs/symptoms of hypercorticism . Single oral doses up to 8000 mcg of mometasone furoate have been studied on human volunteers with no adverse reactions reported.
How should I store and handle ASMANEX HFA?
The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read "0").Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].For best results, the canister should be at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.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.
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ()Hypersensitivity to any of the ingredients of ASMANEX HFA. ()
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.
ASMANEX HFA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta-agonist, not ASMANEX HFA, should be used to relieve acute symptoms such as shortness of breath. When prescribing ASMANEX HFA, the physician must also provide the patient with an inhaled, short-acting beta-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of ASMANEX HFA. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with ASMANEX HFA. During such episodes, patients may require therapy with oral corticosteroids.
Systemic and local corticosteroid use may result in the following:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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