Symptomatic management or prevention of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).
Exercise-induced Bronchospasm
Prevention of exercise-induced bronchospasm.
COPD
Albuterol sulfate in fixed combination with ipratropium bromide: Symptomatic management of reversible bronchospasm associated with COPD in patients who continue to have evidence of bronchospasm despite regular use of an orally inhaled bronchodilator and who require a second bronchodilator.
Albuterol or albuterol sulfate: Symptomatic management of reversible bronchospasm associated with COPD† when given on an as-needed or regular (e.g., 4 times daily) basis, either alone or concomitantly with other inhaled bronchodilators. Regular use of a selective, short-acting inhaled β2-adrenergic agonist (e.g., albuterol) in the management of COPD, in contrast to that in asthma, does not appear to be detrimental.
Dosage and Administration
General
Albuterol or albuterol sulfate: Administer by oral inhalation via metered-dose inhaler or nebulizer or orally.
Albuterol sulfate in fixed combination with ipratropium bromide: Administer by oral inhalation via metered-dose aerosol inhaler or nebulizer.
Adjust dosage carefully according to individual requirements and response.
Administration
Oral Inhalation
Metered-dose Inhaler
Administer inhalation aerosol only with the actuator provided by the manufacturer.
Shake inhaler well before use.
Test-spray inhalation aerosol (3 times for ProAir® HFA, 4 times for Ventolin® HFA or Proventil® HFA) into the air (away from the face) before first use and whenever the inhaler has not been used for prolonged periods (i.e., >2 weeks). Test spray Ventolin® HFA aerosol inhaler whenever it has been dropped.
Avoid spraying aerosols into the eyes.
Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it. Inhale slowly and deeply through the mouth. Actuate aerosol inhaler, hold breath for as long as possible, withdraw mouthpiece, and exhale slowly.
Allow 1 minute to elapse between subsequent inhalations from aerosol inhaler.
Clean the albuterol sulfate inhalation aerosol (Proventil® HFA, ProAir® HFA, Ventolin® HFA) inhaler by removing the metal canister and running warm water through the plastic mouthpiece of the actuator for 30 seconds at least once a week. Clean the albuterol inhalation aerosol (Proventil®) by removing the metal canister and running warm water through the plastic case and cap at least once daily. Dry thoroughly the mouthpiece or the plastic case and cap of inhaler before replacing the metal canister. If the inhaler is to be used before it is completely dry, shake off excess water, replace the canister, and test the inhaler by spraying once (Ventolin® HFA) or twice (ProAir® HFA, Proventil® HFA) away from the face before administering the dose. After such use, the mouthpiece should be rewashed and allowed to air dry. Proper cleaning of the albuterol sulfate inhaler (Proventil® HFA, Ventolin® HFA, ProAir® HFA) mouthpiece will prevent medication build-up and blockage.
Discard canister after the labeled number of actuations have been used.
Nebulization
When administering via nebulization, use proper aseptic technique to avoid microbial contamination.
For administration of albuterol sulfate solution for nebulization in single-use units, empty the entire contents of a single-use unit into the nebulizer reservoir and use immediately to avoid microbial contamination. For administration of single-use units of albuterol sulfate 0.5% concentrate solution for nebulization, empty the entire contents of the plastic vial into the nebulizer reservoir and add 2.5 mL of 0.9% sodium chloride solution into the nebulizer reservoir to provide a final volume of 3 mL.
Attach the reservoir to the mouthpiece or face mask and to the compressor according to the manufacturer’s instructions.
Place the mouthpiece of the nebulizer in the mouth or put on the nebulizer face mask and turn on the compressor. Breathe as calmly, deeply, and evenly as possible until the nebulizer stops producing mist (flow rate of nebulizer should be adjusted to provide the full dose over about 5–15 minutes).
Clean the nebulizer after use according to the manufacturer’s instructions.
Continue nebulization therapy as necessary to control recurrent bronchospasm. Optimum benefit is obtained when nebulization is used regularly.
Oral Administration
Albuterol sulfate extended-release tablets should not be chewed or crushed.
Dosage
Available as albuterol or albuterol sulfate; dosage expressed in terms of albuterol.
Pediatric Patients
Bronchospasm
Asthma
Oral Inhalation
Inhalation aerosol without chlorofluorocarbons in children ≥4 years of age: 180 mcg (2 inhalations) every 4–6 hours (Ventolin® HFA, Proventil® HFA). Do not increase dosage or dosage frequency. Alternatively, 90 mcg (1 inhalation) every 4 hours may be sufficient.
Inhalation aerosol with chlorofluorocarbons in adolescents ≥12 years of age: 180 mcg (2 inhalations) every 4–6 hours (Proventil®).
Inhalation aerosol without chlorofluorocarbons in adolescents ≥12 years of age: 180 mcg (2 inhalations) every 4–6 hours (ProAir® HFA).
0.042% Inhalation solution for nebulization in children 2–12 years of age: 0.63 or 1.25 mg 3 or 4 times daily. Dosage of 1.25 mg 3 or 4 times daily may improve initial response in children 6–12 years of age with more severe asthma (baseline FEV1 <60% of predicted), patients weighing >40 kg, or children 11–12 years of age. For acute exacerbations, a 0.083% solution containing 2.5 mg of albuterol per 3 mL may be more appropriate, particularly in children ≥6 years of age.
0.083% Inhalation solution for nebulization in children 2–12 years of age: 2.5 mg 3 or 4 times daily in children weighing ≥15 kg. Do not increase dosage or dosage frequency. In children 2–12 years of age weighing<15 kg who require <2.5 mg per dose, the 0.5% inhalation solution should be used to prepare the appropriate dose for nebulization.
0.083% Inhalation solution for nebulization in adolescents ≥12 years of age: 2.5 mg 3 or 4 times daily (Proventil® single-use inhalation solution).
0.5% Inhalation solution for nebulization in adolescents ≥12 years of age: 2.5 mg 3–4 times daily.
Oral
Conventional tablets in children 6–12 years of age: Initially, 2 mg 3 or 4 times daily. If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 6 mg 4 times daily (maximum 24 mg total daily dosage).
Conventional tablets in adolescents ≥12 years of age: Initially, 2 or 4 mg 3 or 4 times daily. If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 8 mg 4 times daily (maximum 32 mg total daily dosage).
Extended-release tablets in children 6–12 years of age: Initially, 4 mg every 12 hours (VoSpire® ER). If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 12 mg twice daily (maximum 24 mg total daily dosage).
Extended-release tablets in adolescents ≥12 years of age: Initially, 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient (e.g., low body weight). If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 16 mg twice daily (maximum 32 mg total daily dosage). When transferring from conventional tablets to extended-release tablets, each 2 mg administered every 6 hours as conventional tablets is approximately equivalent to 4 mg every 12 hours as extended-release tablets.
Oral solution in children 2–6 years of age: Initially, 0.1 mg/kg (up to 2 mg) 3 times daily. If necessary, increase dosage cautiously and gradually as tolerated to 0.2 mg/kg (up to 4 mg) 3 times daily (maximum 12 mg total daily dosage).
Oral solution in children or adolescents >6–14 years of age: Initially, 2 mg 3 or 4 times daily. If necessary increase dosage cautiously and gradually as tolerated to a maximum of 24 mg daily in divided doses.
Oral solution in adolescents >14 years of age: 2 or 4 mg 3–4 times daily. If necessary, increase dosage cautiously and gradually to a maximum of 8 mg 4 times daily.
Exercise-induced Bronchospasm
Prevention
Oral Inhalation
Inhalation aerosol with chlorofluorocarbons in children ≥12 years of age: 180 mcg (2 inhalations) administered 15 minutes before exercise via metered-dose inhaler (Proventil®).
Inhalation aerosol without chlorofluorocarbons in children ≥4 years of age: 180 mcg (2 inhalations) administered 15–30 minutes before exercise via metered-dose inhaler (Ventolin® HFA, Proventil® HFA).
Inhalation aerosol without chlorofluorocarbons in children ≥12 years of age: 180 mcg (2 inhalations) administered 15–30 minutes before exercise via metered-dose inhaler (ProAir® HFA).
Adults
Bronchospasm
Asthma
Oral Inhalation
Inhalation aerosol: 180 mcg (2 inhalations) every 4–6 hours. Do not increase dosage or dosage frequency of orally inhaled albuterol aerosol. Alternatively, 90 mcg (1 inhalation) every 4 hours.
Inhalation solution for nebulization: 2.5 mg 3 or 4 times daily. Do not increase dosage or dosage frequency.
Oral
Conventional tablets or oral solution: Initially, 2 or 4 mg 3 or 4 times daily. If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 8 mg 4 times daily.
Extended-release tablets: Initially, 4 or 8 mg every 12 hours. In some patients (e.g., low body weight), 4 mg every 12 hours may be sufficient. If necessary, increase dosage cautiously and gradually as tolerated to maximum of 16 mg twice daily.
Exercise-induced Bronchospasm
Prevention
Oral inhalation
Inhalation aerosol with chlorofluorocarbons: 180 mcg (2 inhalations) administered 15 minutes before exercise (Proventil®).
Inhalation aerosol without chlorofluorocarbons: 180 mcg (2 inhalations) administered 15–30 minutes before exercise via the metered-dose inhaler (Ventolin® HFA, ProAir® HFA, Proventil® HFA).
Bronchospasm
COPD
Oral Inhalation
Inhalation aerosol: Initially, 180 mcg (2 inhalations) 4 times daily in fixed combination with ipratropium bromide (18 mcg per inhalation). If necessary, additional inhalations may be used, with dosage not exceeding 12 inhalations in 24 hours.
Inhalation solution for nebulization: Initially, 2.5 mg 4 times daily in fixed combination with ipratropium bromide (0.5 mg per dose) (DuoNeb®). If necessary, may administer 2.5 mg in fixed combination with ipratropium bromide (0.5 mg per dose) up to 6 times daily.
Prescribing Limits
Pediatric Patients
Bronchospasm
Asthma
Oral Inhalation
Inhalation aerosol with chlorofluorocarbons in adolescents ≥12 years of age: Maximum 180 mcg (2 inhalations) 4 times daily (Proventil®).
Inhalation aerosol without chlorofluorocarbons in children ≥4 years of age: Maximum 180 mcg (2 inhalations) 4 times daily (Ventolin® HFA, Proventil® HFA).
Inhalation solution for nebulization in children 2–12 years of age: Maximum 2.5 mg 4 times daily in children weighing at least 15 kg.
Inhalation solution for nebulization in adolescents ≥12 years of age: Maximum 2.5 mg 4 times daily.
Oral
Conventional tablets in children 6–12 years of age: Maximum 24 mg daily (in divided doses).
Conventional tablets in adolescents 12 years of age: Maximum 8 mg 4 times daily.
Extended-release tablets in children 6–12 years of age: Maximum 12 mg twice daily.
Extended-release tablets in adolescents >12 years of age: Maximum 16 mg twice daily.
Oral solution in children 2–6 years of age: Maximum 4 mg 3 times daily.
Oral solution in children or adolescents >6 to 14 years of age: Maximum 24 mg daily in divided doses.
Oral solution in adolescents >14 years of age: Maximum 8 mg 4 times daily.
Exercise-induced Bronchospasm
Prevention
Oral Inhalation
Inhalation aerosol: Maximum 12 inhalations in 24 hours in children ≥4 years of age (Ventolin® HFA, Proventil® HFA) or adolescents ≥12 years of age (Proventil®, ProAir® HFA).
Adults
Bronchospasm
Asthma
Oral Inhalation
Inhalation aerosol: Maximum 180 mcg (2 inhalations) 4 times daily.
Inhalation solution for nebulization: Maximum 2.5 mg 4 times daily.
Oral
Conventional tablets or oral solution: Maximum 8 mg 4 times daily.
Extended-release tablets: Maximum 16 mg twice daily.
Exercise-induced Bronchospasm
Prevention
Oral Inhalation
Inhalation aerosol: Maximum 12 inhalations in 24 hours.
Bronchospasm
COPD
Oral Inhalation
Inhalation aerosol: Maximum 180 mcg (2 inhalations) 4 times daily in fixed combination with ipratropium bromide (18 mcg per inhalation).
Inhalation solution for nebulization: Maximum 2.5 mg 6 times daily in fixed combination with ipratropium bromide (0.5 mg per dose).
Special Populations
Geriatric Patients
Conventional tablets or oral solution: Initially, 2 mg 3 or 4 times daily. May increase gradually as tolerated up to a maximum of 8 mg 3 or 4 times daily (conventional tablets).
Inhalation aerosol: Initiate therapy with dosages at the lower end of the usual range.
Patients Sensitive to Sympathomimetic Amines
Conventional tablets or oral solution: Initially, 2 mg 3 or 4 times daily. May increase gradually as tolerated up to 8 mg 3 or 4 times daily.
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