Albuterol 2 mg/1
Albuterol · TABLET · Amneal Pharmaceuticals NY LLC
Albuterol is a prescription tablet taken by mouth to treat asthma and other breathing problems by relaxing the muscles in the airways. It belongs to a class of medications called bronchodilators.
Key Facts
- Brand Name
- Albuterol
- Generic Name
- Albuterol
- NDC Code (Product)
69238-1344- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 2 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA208804
- Drug Class
- Adrenergic beta2-Agonists [MoA]; beta2-Adrenergic Agonist [EPC]
- Marketing Start
- 05/24/2018
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
AsttraZeneca Pharmaceuticals LP
Defective delivery system
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.
Integrated Health Concepts Inc. dba Conversio Health
Lack of Processing Controls
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 used for?
Albuterol is a prescription tablet taken by mouth to treat asthma and other breathing problems by relaxing the muscles in the airways. It belongs to a class of medications called bronchodilators.
Is Albuterol a controlled substance?
Albuterol is not classified as a controlled substance by the DEA.
What is the generic name for Albuterol?
The generic name for Albuterol is Albuterol. There are 9 other brand versions of Albuterol.
What is the NDC code for Albuterol 2 mg/1?
The NDC (National Drug Code) for Albuterol 2 mg/1 is 69238-1344, listed by Amneal Pharmaceuticals NY LLC.
Other Albuterol Dosages
Other Albuterol Brands
See all →- Ipratropium Bromide and Albuterol Sulfate3 mg/3mL71205-051
- Albuterol Sulfate2.5 mg/3mL0487-9501
- Albuterol Sulfate108 ug/10781-7296
- VENTOLIN HFA90 ug/170518-1237
- Albuterol Sulfate2.5 mg/3mL64980-641
- Albuterol Sulfate1.25 mg/3mL64980-644
- Albuterol Sulfate2.5 mg/.5mL64980-642
- Albuterol Sulfate.63 mg/3mL64980-643
- VENTOLIN HFA90 ug/10173-0682
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)