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Xopenex HFA (Levalbuterol Tartrate) - Summary

 
 



XOPENEX HFA SUMMARY

The active component of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta2-adrenergic receptor agonist.

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.


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NEWS HIGHLIGHTS

Published Studies Related to Xopenex HFA (Levalbuterol)

Efficacy of racemic albuterol versus levalbuterol used as a continuous nebulization for the treatment of acute asthma exacerbations: a randomized, double-blind, clinical trial. [2011.03]
OBJECTIVE: To compare racemic albuterol (RAC) with levalbuterol (LEV) in continuous form for the treatment of acute pediatric asthma exacerbations in the emergency department... CONCLUSIONS: At the doses used, RAC appears to be superior to LEV with respect to changes in FEV1 and asthma score. There was no significant difference between the drugs with respect to admission rates or side-effect profile.

Efficacy of racemic albuterol versus levalbuterol used as a continuous nebulization for the treatment of acute asthma exacerbations: a randomized, double-blind, clinical trial. [2011]
emergency department... CONCLUSIONS: At the doses used, RAC appears to be superior to LEV with respect to

Levalbuterol versuss levalbuterol plus ipratropium in the treatment of severe acute asthma. [2010.12]
BACKGROUND: The National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 guidelines advise the addition of ipratropium bromide to short-acting beta-agonist therapy for the treatment of patients with severe acute asthma exacerbation... CONCLUSION: We were unable to demonstrate superiority of adding ipratropium to levalbuterol in alleviating obstruction as measured by FEV or in decreasing the need for hospitalization among adult patients presenting to the ED with acute severe asthma exacerbation.

High-dose continuous nebulized levalbuterol for pediatric status asthmaticus: a randomized trial. [2009.08]
OBJECTIVE: To assess the use of high-dose continuous levalbuterol (LEV), the single active (R)-enantiomer of racemic albuterol (RAC), in the treatment of status asthmaticus... CONCLUSIONS: Substituting high-dose continuous LEV for RAC did not reduce the time on continuous therapy and had similar adverse effects in children who had failed initial treatment with RAC.

A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects. [2008.09]
BACKGROUND: The short-acting beta(2)-agonists levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI). OBJECTIVE: This study compared the short-term safety and efficacy of cumulative doses of levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects... CONCLUSION: In this study single-day cumulative dosing of asthmatic subjects with levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV(1) and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with levalbuterol HFA MDI.

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Clinical Trials Related to Xopenex HFA (Levalbuterol)

Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED) [Completed]
The purpose of this study is to determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate [Completed]

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children [Completed]
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis

- Children with severe asthma receiving continuous levalbuterol will have a shorter

duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses

- Children receiving continuous levalbuterol will have improved lung function measured by

forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.

- Children receiving continuous levalbuterol will have improved clinical asthma score as

compared to racemic albuterol.

Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients [Completed]
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose levels equivalent to 90 mcg and 180 mcg of albuterol base.

Preterm Infant Inhaled Albuterol Dosing [Recruiting]
The purpose of this study is to help determine the best dose of albuterol in premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of prematurity and is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication frequently used in premature infants with chronic lung disease and in people with asthma. It is believed to be safe, but the optimal dose for infants is not clear. The investigators hypothesize that albuterol may help a subset of premature infants with lung disease, but they need to determine the best dose prior to doing research about how effective it is for chronic lung disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary function tests.

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Reports of Suspected Xopenex HFA (Levalbuterol) Side Effects

Implantable Defibrillator Insertion (1)Hypersensitivity (1)Adverse Drug Reaction (1)Tachycardia (1)Ventricular Arrhythmia (1)Hypokalaemia (1)Haematocrit Decreased (1)Laboratory Test Abnormal (1)Road Traffic Accident (1)Food Allergy (1)more >>


Page last updated: 2013-02-10

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