Albuterol Sulfate HFA 90 ug/1

albuterol sulfate · AEROSOL, METERED · Advanced Rx of Tennessee, LLC

1 Recall on RecordCurrently in Shortage

Plain English

Albuterol Sulfate HFA is a aerosol, metered containing albuterol sulfate at 90 ug/1, taken respiratory (inhalation). Manufactured by Advanced Rx of Tennessee, LLC.

Key Facts

Brand Name: Albuterol Sulfate HFA
Generic Name: albuterol sulfate
NDC Code (Product): 80425-0359
Manufacturer: Advanced Rx of Tennessee, LLC
Strength: 90 ug/1
Dosage Form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA020983
Marketing Start: 09/07/2023

Recall History

1 Recall on Record

Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea12,511 reports

wrong technique in product usage process10,580 reports

no adverse event8,270 reports

device delivery system issue7,805 reports

drug dose omission by device7,509 reports

asthma6,672 reports

cough5,945 reports

drug ineffective5,090 reports

fatigue4,831 reports

product dose omission issue4,728 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Albuterol Sulfate 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 Albuterol Sulfate HFA Inhalation Aerosol 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 Albuterol Sulfate 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 Albuterol Sulfate 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 Albuterol Sulfate 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 …

Contraindications

4 CONTRAINDICATIONS Albuterol Sulfate 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 albuterol sulfate 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 bet…

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 Prasco Laboratories at 1-866-525-0688 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 albuterol sulfate HFA in 248 subjects treated with albuterol sulfate HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. The data from adults…

Frequently Asked Questions

What is Albuterol Sulfate HFA used for?

Albuterol Sulfate HFA contains albuterol sulfate. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.

Is Albuterol Sulfate HFA a controlled substance?

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

What is the generic name for Albuterol Sulfate HFA?

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

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

The NDC (National Drug Code) for Albuterol Sulfate HFA 90 ug/1 is 80425-0359, listed by Advanced Rx of Tennessee, LLC.

Product NDC

80425-0359

Package NDC

80425-0359-1

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)