Albuterol Sulfate

Bronchospasm in Asthma

Symptomatic management or prevention of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).132 139 154 181 241 249 255 282

Exercise-induced Bronchospasm

Prevention of exercise-induced bronchospasm.132 181 249

Chronic Obstructive Pulmonary Disease

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.233 250 251 252

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.181 206 251 266 267 268 269 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.206 247 250 251

General

• Albuterol sulfate: Administer by oral inhalation via metered-dose inhaler or nebulizer114 153 181 212 237 241 242 244 255 258 or orally.100 139 154 208 281

• Albuterol sulfate in fixed combination with ipratropium bromide: Administer by oral inhalation via metered-dose aerosol inhaler233 or nebulizer.243

• Adjust dosage carefully according to individual requirements and response.139 145 146 153 154 208 212 255

Administration

Oral Inhalation

Metered-dose Aerosol Inhaler

Administer inhalation aerosol only with the actuator provided by the manufacturer.146 181 210 215

Shake inhaler well before use.146 181 210 215

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 not used for prolonged periods (i.e., >2 weeks).181 215 237 248 282 Test spray Ventolin HFA aerosol inhaler whenever dropped.237

Avoid spraying aerosols into the eyes.181 210 215

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it.210 215 Inhale slowly and deeply through the mouth.210 215 Actuate aerosol inhaler, hold breath for as long as possible, withdraw mouthpiece, and exhale slowly.210 215

Allow 1 minute to elapse between subsequent inhalations from aerosol inhaler.248 261

Clean the albuterol sulfate inhalation aerosol (ProAir HFA, Proventil 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.181 237 282 Dry thoroughly the mouthpiece before replacing the metal canister and mouthpiece cap.181 215 237 282 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.237 248 282 After such use, rewash the mouthpiece and allow to air dry.248 282 Proper cleaning of the albuterol sulfate inhaler (ProAir HFA, Proventil HFA, Ventolin HFA) mouthpiece will prevent medication build-up and blockage.181 237 248 282

Discard canister after the labeled number of actuations used.181 233 237 282

Nebulization

When administering via nebulization, use proper aseptic technique to avoid microbial contamination.114 241

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.241 242 243 255 256 263 283 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.272 273

Attach the reservoir to the mouthpiece or face mask and to the compressor according to the manufacturer’s instructions.213 256 257 263 283

Place the mouthpiece of the nebulizer in the mouth or put on the nebulizer face mask and turn on the compressor.213 256 257 263 283 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).213 256 257 263 283

Clean the nebulizer after use according to the manufacturer’s instructions.213 241 244 245 246 256 257 263 283

Continue nebulization therapy as necessary to control recurrent bronchospasm.249 258 Optimum benefit is obtained when nebulization is used regularly.249 258

Oral Administration

Albuterol sulfate extended-release tablets should not be chewed or crushed.100 154 271

Dosage

Available as albuterol sulfate; dosage expressed in terms of albuterol.114 153 154 181 272 281

Pediatric Patients

Bronchospasm in Asthma Oral Inhalation Aerosol

Children ≥4 years of age: 180 mcg (2 inhalations) every 4–6 hours (ProAir HFA, Proventil HFA, Ventolin HFA).181 237 295 Do not increase dosage or dosage frequency.181 237 295 Alternatively, 90 mcg (1 inhalation) every 4 hours may be sufficient.181 237 295

Oral Nebulization Solution

0.042% Inhalation solution for nebulization in children 2–12 years of age: 0.63 or 1.25 mg 3 or 4 times daily.255 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.255 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.255 258

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.153 258 Do not increase dosage or dosage frequency.114 153 212 241 255 258 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.153 255 258 212

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).241 258

0.5% Inhalation solution for nebulization in adolescents ≥12 years of age: 2.5 mg 3–4 times daily.272

Oral Conventional Tablets

Children 6–12 years of age: Initially, 2 mg 3 or 4 times daily.280 If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 6 mg 4 times daily (maximum 24 mg total daily dosage).280

Adolescents ≥12 years of age: Initially, 2 or 4 mg 3 or 4 times daily.280 If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 8 mg 4 times daily (maximum 32 mg total daily dosage).280

Oral Extended-release Tablets

Children 6–12 years of age: Initially, 4 mg every 12 hours (VoSpire ER).271 If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 12 mg twice daily (maximum 24 mg total daily dosage).271

Adolescents ≥12 years of age: Initially, 8 mg every 12 hours.271 In some patients, 4 mg every 12 hours may be sufficient (e.g., low body weight).271 If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 16 mg twice daily (maximum 32 mg total daily dosage).271 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.271

Oral Solution

Children 2–6 years of age: Initially, 0.1 mg/kg (up to 2 mg) 3 times daily.281 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).281

Children or adolescents >6–14 years of age: Initially, 2 mg 3 or 4 times daily.281 If necessary increase dosage cautiously and gradually as tolerated to a maximum of 24 mg daily in divided doses.281

Adolescents >14 years of age: 2 or 4 mg 3–4 times daily.281 If necessary, increase dosage cautiously and gradually to a maximum of 8 mg 4 times daily.281

Prevention of Exercise-induced Bronchospasm Oral Inhalation Aerosol

Children ≥4 years of age: 180 mcg (2 inhalations) administered 15–30 minutes before exercise via metered-dose inhaler (ProAir HFA, Proventil HFA, Ventolin HFA).181 237 295

Adults

Bronchospasm in Asthma Oral Inhalation Aerosol

180 mcg (2 inhalations) every 4–6 hours.181 237 282 Do not increase dosage or dosage frequency of orally inhaled albuterol aerosol.137 282 Alternatively, 90 mcg (1 inhalation) every 4 hours.145 146 181 237 282

Oral Nebulization Solution

2.5 mg 3 or 4 times daily.114 212 241 258 Do not increase dosage or dosage frequency.114 153 212 241 255 258

Oral Conventional Tablets or Solution

Initially, 2 or 4 mg 3 or 4 times daily.100 139 262 208 280 If necessary, increase dosage cautiously and gradually as tolerated to a maximum of 8 mg 4 times daily.100 139 208 262 280

Oral Extended-release Tablets

Initially, 4 or 8 mg every 12 hours.271 In some patients (e.g., low body weight), 4 mg every 12 hours may be sufficient.271 If necessary, increase dosage cautiously and gradually as tolerated to maximum of 16 mg twice daily.271

Prevention of Exercise-induced Bronchospasm Oral Inhalation Aerosol

180 mcg (2 inhalations) administered 15–30 minutes before exercise via the metered-dose inhaler (ProAir HFA, Proventil HFA, Ventolin HFA).181 237 282

Chronic Obstructive Pulmonary Disease Oral Inhalation Aerosol

Initially, 180 mcg (2 inhalations) 4 times daily in fixed combination with ipratropium bromide (18 mcg per inhalation).233 If necessary, additional inhalations may be used, with dosage not >12 inhalations in 24 hours.233

Oral Nebulization Solution

Initially, 2.5 mg 4 times daily in fixed combination with ipratropium bromide (0.5 mg per dose) (DuoNeb).243 If necessary, may administer 2.5 mg in fixed combination with ipratropium bromide (0.5 mg per dose) up to 6 times daily.243

Prescribing Limits

Pediatric Patients

Bronchospasm in Asthma Oral Nebulization Solution

Children 2–12 years of age: Maximum 2.5 mg 4 times daily in children weighing at least 15 kg.153 258

Adolescents ≥12 years of age: Maximum 2.5 mg 4 times daily.153

Oral Conventional Tablets

Children 6–12 years of age: Maximum 24 mg daily (in divided doses).280

Adolescents ≥12 years of age: Maximum 8 mg 4 times daily.100 139 280

Oral Extended-release Tablets

Children 6–12 years of age: Maximum 12 mg twice daily.271

Adolescents >12 years of age: Maximum 16 mg twice daily.271

Oral Solution

Children 2–6 years of age: Maximum 4 mg 3 times daily.281

Children or adolescents >6 to 14 years of age: Maximum 24 mg daily in divided doses.270 281

Adolescents >14 years of age: Maximum 8 mg 4 times daily.281

Adults

Bronchospasm in Asthma Oral Nebulization Solution

Maximum 2.5 mg 4 times daily.114 153 241 258 212

Oral Conventional Tablets or Solution

Maximum 8 mg 4 times daily.270 280 281

Oral Extended-release Tablets

Maximum 16 mg twice daily.271

Chronic Obstructive Pulmonary Disease Oral Inhalation Aerosol

Maximum 180 mcg (2 inhalations) 4 times daily in fixed combination with ipratropium bromide (18 mcg per inhalation).233

Oral Nebulization Solution

Maximum 2.5 mg 6 times daily in fixed combination with ipratropium bromide (0.5 mg per dose).243

Special Populations

Geriatric Patients

Oral Conventional Tablets or Solution

Initially, 2 mg 3 or 4 times daily.280 281 May increase gradually as tolerated up to a maximum of 8 mg 3 or 4 times daily (conventional tablets).280

Oral Inhalation Aerosol

Initiate therapy with dosages at the lower end of the usual range.237 282

Patients Sensitive to Sympathomimetic Amines

Oral Conventional Tablets or Solution

Initially, 2 mg 3 or 4 times daily.280 281 May increase gradually as tolerated up to 8 mg 3 or 4 times daily.280

Specific Drugs

Drug	Interaction	Comments
β-Adrenergic blocking agents	Antagonism of pulmonary effects resulting in severe bronchospasm in asthmatic patients181 241	If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents181 241 281
Digoxin	Decreased serum digoxin concentrations181 241	Careful evaluation of serum digoxin concentrations recommended181 241
Diuretics, nonpotassium-sparing	Decreased serum potassium concentrations and/or ECG changes, especially when the recommended β-agonist dose is exceeded181 241 281	Cautious use recommended181 241 281
MAO inhibitors	Increased effect on vascular system181 241	Extreme caution recommended with concomitant therapy181 241 or in patients receiving albuterol within 2 weeks of discontinuance of these agents115 132 139 146 153 154 181
Sympathomimetic agents (e.g., epinephrine)	Increased cardiovascular adverse effects241	Avoid concomitant use of inhaled albuterol and other short-acting inhaled sympathomimetic amine bronchodilators or oral albuterol and other oral sympathomimetic agents114 237 241 Concomitant oral albuterol and inhaled sympathomimetic agent may be used on individualized basis270 271 280 281 If such concomitant use regularly required, consider alternative therapy270 271 280 281

• Stimulates β-adrenergic receptors with little or no effect on α-adrenergic receptors.j

• Stimulates the production of cyclic adenosine-3′,5′-monophosphate (AMP), which mediates numerous cellular responses, including smooth muscle relaxation and inhibiting the release of mediators from mast cells in the airways.153 181 208

• Relaxes smooth muscles from the trachea to the terminal bronchial tree.j

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Albuterol Sulfate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	2 mg (of albuterol) per 5 mL*	Albuterol Sulfate Syrup
	Tablets	2 mg (of albuterol)*	Albuterol Sulfate Tablets
		4 mg (of albuterol)*	Albuterol Sulfate Tablets
	Tablets, extended-release	4 mg (of albuterol)*	VoSpire ER	Dava
			Albuterol Sulfate Extended-Release Tablets
		8 mg (of albuterol)*	VoSpire ER	Dava
			Albuterol Sulfate Extended-Release Tablets
Oral Inhalation	Aerosol	90 mcg (of albuterol) per metered spray	ProAir HFA (with hydrofluoroalkane propellant)	Teva
			Proventil HFA (with hydrofluoroalkane propellant)	Schering
			Ventolin+ HFA (with hydrofluoroalkane propellant)	GlaxoSmithKline
	Solution, for nebulization	0.021% (of albuterol)*	AccuNeb (available as TwistFlex polyethylene vials)	Dey
			Albuterol Sulfate Inhalation Solution
		0.042% (of albuterol)*	AccuNeb (available as TwistFlex polyethylene vials)	Dey
			Albuterol Sulfate Inhalation Solution
		0.083% (of albuterol)*	Albuterol Sulfate Inhalation Solution
			Proventil	Schering
	Solution, concentrate, for nebulization	0.5% (of albuterol)*	Albuterol Sulfate Inhalation Solution

Albuterol Sulfate Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Aerosol	90 mcg (of albuterol) with Ipratropium Bromide 18 mcg per metered spray	Combivent (with chlorofluorohydrocarbon propellants)	Boehringer Ingelheim
	Solution, for nebulization	2.5 mg (of albuterol) with Ipratropium Bromide 0.5 mg per 3 mL	DuoNeb	Dey

Levalbuterol Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution, for nebulization	0.103 mg (of levalbuterol) per mL (0.31 mg)	Xopenex (available as polyethylene vials)	Sepracor
		0.21 mg (of levalbuterol) per mL (0.63 mg)	Xopenex (available as polyethylene vials)	Sepracor
		0.417 mg (of levalbuterol) per mL (1.25 mg)	Xopenex (available as polyethylene vials)	Sepracor

Levalbuterol Tartrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Aerosol	45 mcg (of levalbuterol) per metered spray	Xopenex HFA (with hydrofluoroalkane propellant)	Sepracor