Drugplain

VENTOLIN HFA 90 ug/1

albuterol sulfate · AEROSOL, METERED · NuCare Pharmaceuticals,Inc.

4 Recalls on RecordCurrently in Shortage
Plain English

Ventolin HFA is a rescue inhaler containing albuterol that works by relaxing airway muscles to quickly relieve breathing problems during asthma attacks or other airway obstruction. You inhale this medication directly into your lungs when you need immediate relief from wheezing, shortness of breath, or chest tightness.

Key Facts

Brand Name
VENTOLIN HFA
Generic Name
albuterol sulfate
NDC Code (Product)
68071-1670
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
90 ug/1
Dosage Form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA020983
Marketing Start
06/09/2006

Recall History

4 Recalls on Record
Class II07/26/2012

GlaxoSmithKline Inc

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

TerminatedVoluntary: Firm initiated
Class II03/22/2017

GlaxoSmithKline, LLC

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

OngoingVoluntary: Firm initiated
Class II12/03/2015

GlaxoSmithKline, LLC

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

TerminatedVoluntary: Firm initiated
Class II05/16/2017

GlaxoSmithKline, LLC

Defective Delivery System: Elevated number of units with out of specification results for leak rate

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea27,098 reports
wrong technique in product usage process17,785 reports
asthma16,841 reports
drug ineffective13,075 reports
cough13,023 reports
fatigue10,127 reports
pneumonia9,928 reports
headache9,395 reports
wheezing9,140 reports
no adverse event8,503 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VENTOLIN HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 ) 1.1 Bronchospasm VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2 ) Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. ( 2.2 ) Priming information: Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. ( 2.3 ) Cleaning information: At least once a week, wash the actuator with warm water and let it air-dry completely. ( 2.3 ) 2.1 Recommended Dosage for Bronchospasm (Acute Episodes or Symptoms Associated with Bronchospasm) Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a greater number of inhalations is …

Contraindications

4 CONTRAINDICATIONS VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.6 ), Description ( 11 )] . Hypersensitivity to any ingredient. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.1 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.3 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of albuterol on vascular system. ( 7.4 ) 7.1 Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as VENTOLIN HFA, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrener…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )] Cardiovascular effects [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions, including anaphylaxis [see Warnings and Precautions ( 5.6 )] Hypokalemia [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflects exposure to VENTOLIN HFA in 248 subjects treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents is ba…

Frequently Asked Questions

What is VENTOLIN HFA used for?

Ventolin HFA is a rescue inhaler containing albuterol that works by relaxing airway muscles to quickly relieve breathing problems during asthma attacks or other airway obstruction. You inhale this medication directly into your lungs when you need immediate relief from wheezing, shortness of breath, or chest tightness.

Is VENTOLIN HFA a controlled substance?

VENTOLIN HFA is not classified as a controlled substance by the DEA.

What is the generic name for VENTOLIN HFA?

The generic name for VENTOLIN HFA is albuterol sulfate. There are 11 other brand versions of albuterol sulfate.

What is the NDC code for VENTOLIN HFA 90 ug/1?

The NDC (National Drug Code) for VENTOLIN HFA 90 ug/1 is 68071-1670, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-1670

Package NDC

68071-1670-2

Other VENTOLIN HFA Dosages

Other Albuterol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)