Albuterol Sulfate 2.5 mg/3mL
Albuterol Sulfate · SOLUTION · Nephron Pharmaceuticals Corporation
Albuterol sulfate is a rescue inhaler medication used to quickly relieve airway constriction and wheezing in people with asthma, COPD, or other breathing conditions. This inhalation solution works by relaxing the muscles in the airways to help you breathe more easily during an asthma attack or breathing emergency.
Key Facts
- Brand Name
- Albuterol Sulfate
- Generic Name
- Albuterol Sulfate
- NDC Code (Product)
0487-9501- Manufacturer
- Nephron Pharmaceuticals Corporation
- Strength
- 2.5 mg/3mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA074880
- Marketing Start
- 09/17/1997
Recall History
GlaxoSmithKline Inc
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Perrigo Company PLC
Defective Delivery System: Sustained trend of failure to dispense complaints.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
GlaxoSmithKline, LLC
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Cipla USA, Inc.
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Nephron Pharmaceuticals Corp.
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Nephron SC, LLC
Labelling: Illegible label
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 used for?
Albuterol sulfate is a rescue inhaler medication used to quickly relieve airway constriction and wheezing in people with asthma, COPD, or other breathing conditions. This inhalation solution works by relaxing the muscles in the airways to help you breathe more easily during an asthma attack or breathing emergency.
Is Albuterol Sulfate a controlled substance?
Albuterol Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Albuterol Sulfate?
The generic name for Albuterol Sulfate is Albuterol Sulfate. There are 9 other brand versions of Albuterol Sulfate.
What is the NDC code for Albuterol Sulfate 2.5 mg/3mL?
The NDC (National Drug Code) for Albuterol Sulfate 2.5 mg/3mL is 0487-9501, listed by Nephron Pharmaceuticals Corporation.
Other Albuterol Sulfate Dosages
Other Albuterol Brands
See all →- ALBUTEROL SULFATE90 ug/176282-679
- Albuterol sulfate90 ug/176420-350
- Albuterol Sulfate HFA90 ug/180425-0359
- VENTOLIN HFA90 ug/150090-1159
- Albuterol sulfate90 ug/150090-5231
- ALBUTEROL SULFATE90 ug/150090-5735
- ALBUTEROL SULFATE90 ug/151662-1513
- ALBUTEROL SULFATE2 mg/5mL62135-189
- ALBUTEROL SULFATE90 ug/169097-142
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)