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Ventolin HFA (Albuterol Sulfate HFA Inhalation) - Summary



The active component of VENTOLIN HFA (albuterol sulfate HFA inhalation aerosol) is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator.

VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

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Published Studies Related to Ventolin HFA (Albuterol HFA)

Repeat dosing of albuterol via metered-dose inhaler in infants with acute obstructive airway disease: a randomized controlled safety trial. [2010.03]
BACKGROUND: Airway obstruction and bronchial hyperactivity often times lead to emergency department visits in infants. Inhaled short-acting beta2-agonist bronchodilators have traditionally been dispensed to young children via nebulizers in the emergency department. Delivery of bronchodilators via metered-dose inhalers (MDIs) in conjunction with holding chambers (spacers) has been shown to be effective. STUDY OBJECTIVE:: Safety and efficacy evaluations of albuterol sulfate hydrofluoroalkane (HFA) inhalation aerosol in children younger than 2 years with acute wheezing caused by obstructive airway disease... CONCLUSIONS: Cumulative dosing with albuterol HFA 180 microg or 360 microg via MDI-spacer and face mask in children younger than 2 years did not result in any significant safety issues and improved MTASS by at least 48%.

Safety of daily albuterol in infants with a history of bronchospasm: a multi-center placebo controlled trial. [2009.07.16]
INTRODUCTION: Inhaled short-acting bronchodilators are recommended for the quick relief of bronchospasm symptoms in children including those less than five years of age. However, limited safety data is available in this young population... CONCLUSION: This study provides additional albuterol HFA safety information for the treatment of children aged birth </=24 months with a history of bronchospasm.

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.

Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. [2007.12]
BACKGROUND: Previous studies have raised concerns regarding the safety of regular use of beta2-agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of levalbuterol. OBJECTIVE: To examine the long-term safety of levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma... CONCLUSION: In this trial, up to 52 weeks of regular use of levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period.

An evaluation of levalbuterol HFA in the prevention of exercise-induced bronchospasm. [2007.11]
BACKGROUND: Exercise-induced bronchospasm (EIB) affects up to 90% of all patients with asthma. Objective. This study evaluated the ability of levalbuterol hydrofluoroalkane (HFA) 90 mug (two actuations of 45 microg) administered via metered dose inhaler (MDI) to protect against EIB in mild-to-moderate asthmatics... CONCLUSION: Levalbuterol HFA MDI (90 microg) administered 30 minutes before exercise was significantly more effective than placebo in protecting against EIB after a single exercise challenge and was well tolerated. CLINICAL IMPLICATIONS: Levalbuterol HFA MDI when administered before exercise was effective in protecting adults with asthma from EIB.

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Clinical Trials Related to Ventolin HFA (Albuterol HFA)

Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma [Completed]
The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma

Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD) [Completed]
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.

Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients [Active, not recruiting]
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:

1. Placebo control: (HFA propellant only, Treatment P); and

2. Active control: 3M/Key's Proventil-HFA (Treatment R).

The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).

Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma [Completed]

Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects [Completed]
An analysis of the costs and outcomes associated with hospitalization and treatment of Levalbuterol versus Racemic Albuterol in subjects with Asthma and COPD.

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Reports of Suspected Ventolin HFA (Albuterol HFA) Side Effects

Dyspnoea (13)Asthma (7)Drug Ineffective (6)Product Quality Issue (6)Bundle Branch Block Right (5)Fatigue (5)Chest Pain (5)Hypoxia (5)Muscle Spasms (5)Back Pain (5)more >>


Based on a total of 2 ratings/reviews, Ventolin HFA has an overall score of 5.50. The effectiveness score is 6 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.

Ventolin HFA review by 43 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Asthma
Dosage & duration:   two puffs as needed (dosage frequency: 1 year) for the period of 1 year
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   I have had asthma for years and take albuterol. I heard about this new inhaler from a physician at work. He stated that it was a more pure form of the drug. At the time he stated it was expensive to get. At the same time we were finding out that albuterol was being discontinued. The replacement had a horrible taste to it. My son who has severe asthma was even refusing to take the new inhalor. I asked my physician for it specifically at my next visit. He did not hesitate to provide me the prescription. My insurance company doesn't pay much of anything so I worried they would not cover it and they did. I was very happy that it worked so well with no funny taste.
Side effects:   none
Comments:   two puffs as needed every four hours. I have taken albuteral and it does help but this is awesome. It works within seconds and you don't get shaky


Ventolin HFA review by 31 year old male patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Asthma
Dosage & duration:   1 puff, 108 mcg (dosage frequency: daily) for the period of few days before I threw it out
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   None
Side effects:   Increased difficulty breathing, strange taste.
Comments:   I have a prescription for albuterol for sports related asthma. I usually get the Proair inhaler but the pharmacist insisted this was the same and gave it to me. The first day I had it, I went for a run. As usual, about 10 minutes in my chest begins to tighten and I cannot breath. I took a puff of the Ventolin HFA inhaler. No effect. I stopped running. I took another puff. No effect. Still cannot breath. I am now bent over with my hands on my knees struggling to intake air. I took several more puffs from the inhaler. No effect. I am now struggling to remain conscious, I am getting light headed and everything in my vision is pale. I begin to lay on my back, taking a few more puffs of the inhaler. No effect. My throat is now beginning to seize from the sheer force it takes to inhale tablespoon-sized breaths. I have a headache and hear a high pitched whining. I try several more puffs of my inhaler. No effect. I lay on the ground doing controlled breathing for several minutes. I tried a puff of Ventolin HFA here and there with no effect, so I gave it up. I'm laying wondering if this is my last day on Earth. About 15 minutes of pure agony later I catch my breath slightly. I now have an enormous headache and am dizzy. I get to my feet and start to walk toward my apartment (across the street). Along the way, my chest seizes up a couple more times, and a couple more times I use the inhaler. No effect. I now have to wait another month before I can afford a ProAir inhaler before I can even exercise again. I think Ventolin is for underdeveloped little kids who think they have asthma but actually don't. I have real asthma and this stuff almost killed me. The puff that comes out of it is nearly invisible, the puff from a Proair inhaler is actually noticeable and...a 'puff'--about 15x more comes from the Proair compared to the Ventolin. Even waking up in the morning, the slight tightness I have then, Ventolin does nothing for. My girlfriend doesn't understand why I wheeze before AND AFTER I use the Ventolin. Well, it's because it doesn't work for me--in fact, it almost killed me. Everything in this story is true, but I may have taken more puffs from the inhaler than I listed...any ?'s feel free to contact me: thecrookfromthebrook at yahoo.com. Thank you and take care.

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Page last updated: 2010-10-05

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