Levalbuterol Hydrochloride Solution
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Questions & Answers
Side Effects & Adverse Reactions
Like other inhaled beta-adrenergic agonists, Levalbuterol HCl Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Levalbuterol HCl Inhalation Solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Levalbuterol HCl Inhalation Solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.
Levalbuterol HCl Inhalation Solution, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Levalbuterol HCl Inhalation Solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Levalbuterol HCl Inhalation Solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
Immediate hypersensitivity reactions may occur after administration of racemic albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Levalbuterol HCl Inhalation Solution.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Levalbuterol HCl Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
History
There is currently no drug history available for this drug.
Other Information
Levalbuterol HCl Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist (see CLINICAL PHARMACOLOGY). The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:
The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3•HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water.
Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States.
Levalbuterol HCl Inhalation Solution is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).
Sources
Levalbuterol Hydrochloride Solution Manufacturers
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Ritedose Pharmaceuticals, Llc
![Levalbuterol Hydrochloride Solution [Ritedose Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Levalbuterol Hydrochloride Solution | Ritedose Pharmaceuticals, Llc
Children 6–11 years oldThe recommended dosage of Levalbuterol HCl Inhalation Solution for patients 6–11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
Adults and Adolescents ≥12 years oldThe recommended starting dosage of Levalbuterol HCl Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Levalbuterol HCl Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.
Patients receiving the highest dose of Levalbuterol HCl Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of Levalbuterol HCl Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the expected relief, medical advice should be sought immediately, since this is often a sign of seriously worsening asthma that would require reassessment of therapy.
The drug compatibility (physical and chemical), efficacy, and safety of Levalbuterol HCl Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of Levalbuterol HCl Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of Levalbuterol HCl Inhalation Solution when administered using other nebulizer systems have not been established.
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Watson Laboratories, Inc.
Levalbuterol Hydrochloride Solution | Watson Laboratories, Inc.
Children 6–11 years old: The recommended dosage of Levalbuterol HCl Inhalation Solution for patients 6–11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
Adults and Adolescents ≥ 12 years old: The recommended starting dosage of Levalbuterol HCl Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Levalbuterol HCl Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.
Patients receiving the highest dose of Levalbuterol HCl Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of Levalbuterol HCl Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the expected relief, medical advice should be sought immediately, since this is often a sign of seriously worsening asthma that would require reassessment of therapy.
The drug compatibility (physical and chemical), efficacy, and safety of Levalbuterol HCl Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of Levalbuterol HCl Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of Levalbuterol HCl Inhalation Solution when administered using other nebulizer systems have not been established.
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Cardinal Health
Levalbuterol Hydrochloride Solution | Cardinal Health
Children 6 to 11 years oldThe recommended dosage of Levalbuterol Inhalation Solution, USP for patients 6 to 11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
Adults and Adolescents ≥12 years oldThe recommended starting dosage of Levalbuterol Inhalation Solution, USP for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Levalbuterol Inhalation Solution, USP may benefit from a dosage of 1.25 mg three times a day.
Patients receiving the highest dose of Levalbuterol Inhalation Solution, USP should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of Levalbuterol Inhalation Solution, USP can be continued as medically indicated to control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the expected relief, medical advice should be sought immediately, since this is often a sign of seriously worsening asthma that would require reassessment of therapy.
The drug compatibility (physical and chemical), efficacy, and safety of Levalbuterol Inhalation Solution, USP when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of Levalbuterol Inhalation Solution, USP have been established in clinical trials when administered using the PARI LC Jet™ and the PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of Levalbuterol Inhalation Solution, USP when administered using other nebulizer systems have not been established.
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Prasco Laboratories
Levalbuterol Hydrochloride Solution | Prasco Laboratories
Levalbuterol HCl Inhalation Solution is for oral inhalation only. Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose.
Children 6-11 years old: The recommended dosage of Levalbuterol HCl Inhalation Solution for patients 6-11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
Adults and Adolescents ≥12 years old: The recommended starting dosage of Levalbuterol HCl Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Levalbuterol HCl Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.
Patients receiving the highest dose of Levalbuterol HCl Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of Levalbuterol HCl Inhalation Solution can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
The drug compatibility (physical and chemical), efficacy, and safety of Levalbuterol HCl Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of Levalbuterol HCl Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of Levalbuterol HCl Inhalation Solution when administered using other nebulizer systems have not been established.
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Actavis Pharma, Inc.
Levalbuterol Hydrochloride Solution | Actavis Pharma, Inc.
Children 6–11 years old: The recommended dosage of Levalbuterol HCl Inhalation Solution for patients 6–11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
Adults and Adolescents ≥ 12 years old: The recommended starting dosage of Levalbuterol HCl Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Levalbuterol HCl Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.
Patients receiving the highest dose of Levalbuterol HCl Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of Levalbuterol HCl Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the expected relief, medical advice should be sought immediately, since this is often a sign of seriously worsening asthma that would require reassessment of therapy.
The drug compatibility (physical and chemical), efficacy, and safety of Levalbuterol HCl Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of Levalbuterol HCl Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of Levalbuterol HCl Inhalation Solution when administered using other nebulizer systems have not been established.
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Mylan Pharmaceuticals Inc.
Levalbuterol Hydrochloride Solution | Mylan Pharmaceuticals Inc.
Levalbuterol inhalation solution (concentrate) is for oral inhalation only. Dilute with sterile normal saline before administration. Administer by nebulization using a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose. For dosages less than 1.25 mg, the non-concentrate (i.e., levalbuterol inhalation solution, 3 mL) formulation must be used.
Children 6 to 11 Years Old: The recommended dosage of levalbuterol inhalation solution for patients 6 to 11 years old is 0.31 mg administered 3 times a day, by nebulization. Routine dosing should not exceed 0.63 mg 3 times a day.
Adults and Adolescents ≥ 12 Years Old: The recommended starting dosage of levalbuterol inhalation solution for patients 12 years of age and older is 0.63 mg administered 3 times a day, every 6 to 8 hours, by nebulization.
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of levalbuterol inhalation solution may benefit from a dosage of 1.25 mg 3 times a day.
Patients receiving the highest dose of levalbuterol inhalation solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of levalbuterol inhalation solution can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
The drug compatibility (physical and chemical), efficacy, and safety of levalbuterol inhalation solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of levalbuterol inhalation solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of levalbuterol inhalation solution when administered using other nebulizer systems have not been established.
![Levalbuterol Hydrochloride Solution [Watson Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a1e9d249-33d1-4b14-b92e-8f4dccded1da&name=levalbuterol-hydrochloride-solution-12.jpg)
![Levalbuterol Hydrochloride Solution [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6be0f39e-eae0-4636-b1b3-1b31fe38301c&name=4e1b05fd-c41e-4ccb-af52-65e5066b8e21-09.jpg)
![Levalbuterol Hydrochloride Solution [Prasco Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=91b2b443-bdc7-4045-bb94-906199125f49&name=levalbuterol-hcl-inhalation-15.jpg)
![Levalbuterol Hydrochloride Solution [Actavis Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c99a7f95-0092-48c1-9195-3431250633da&name=levalbuterol-hcl-inhalation-solution-usp-12.jpg)
![Levalbuterol Hydrochloride Solution [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=206bbdec-04f0-40e3-a259-32fc6bce20d8&name=image-14.jpg)
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