Albuterol (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(al BYOO ter ole)

Brand Names: US

ProAir HFA; ProAir RespiClick; Proventil HFA; Ventolin HFA; VoSpire ER [DSC]

Brand Names: Canada

Airomir; APO-Salvent; APO-Salvent CFC Free; APO-Salvent Sterules; DOM-Salbutamol; PHL-Salbutamol Respirator [DSC]; PHL-Salbutamol [DSC]; PMS-Salbutamol; RATIO-Salbutamol; SANDOZ Salbutamol [DSC]; TEVA-Salbutamol; TEVA-Salbutamol HFA; Ventolin; Ventolin Diskus; Ventolin HFA; Ventolin PF

Pharmacologic Category

Beta2 Agonist

Dosing: Adult

Bronchospasm:

Oral inhalation:

Metered-dose inhaler (MDI) or dry powder inhaler (90 mcg/actuation): 2 inhalations every 4 to 6 hours as needed (NAEPP 2007). In some patients, 1 inhalation every 4 hours may be sufficient.

Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]:

Acute treatment: 1 to 2 inhalations; additional inhalations may be necessary every 4 to 6 hours as needed if inadequate relief, however, patients should be advised to promptly consult health care provider or seek medical attention if no relief from acute treatment (additional inhalations or more frequent administration are not recommended)

Maintenance (in combination with corticosteroid therapy): 1 to 2 inhalations every 4 to 6 hours as needed (maximum: 8 inhalations daily)

Dry powder inhaler (200 mcg/inhalation): Ventolin Diskus [Canadian product]:

Acute treatment: 1 inhalation (200 mcg) as needed; maximum: 4 inhalations (800 mcg)/day; patient should be advised to promptly consult health care provider or seek medical attention if prior dose fails to provide adequate relief or if control of symptoms lasts <3 hours

Maintenance (in combination with corticosteroid therapy): 1 inhalation (200 mcg) every 4 to 6 hours; maximum: 4 inhalations (800 mcg)/day

Nebulization solution: 2.5 mg 3 to 4 times daily as needed; Quick relief: 1.25 to 5 mg every 4 to 8 hours as needed (NAEPP 2007)

Oral: Note: Oral is not the preferred route for treatment of asthma; inhalation via nebulization or MDI is preferred (NAEPP 2007).

Regular release: 2 to 4 mg/dose 3 to 4 times daily; maximum dose not to exceed 32 mg daily (divided doses)

Extended release: 8 mg every 12 hours; maximum dose not to exceed 32 mg/day (divided doses). A 4 mg dose every 12 hours may be sufficient in some patients, such as adults of low body weight.

IV continuous infusion [Canadian product]: Severe bronchospasm and status asthmaticus: Initial: 5 mcg/minute; may increase up to 10 to 20 mcg/minute at 15- to 30-minute intervals if needed

Exacerbation of asthma (acute, severe) (NAEPP 2007): Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation): 4 to 8 inhalations every 20 minutes for up to 4 hours, then every 1 to 4 hours as needed

Nebulization solution: 2.5 to 5 mg every 20 minutes for 3 doses, then 2.5 to 10 mg every 1 to 4 hours as needed, or 10 to 15 mg/hour by continuous nebulization

Exercise-induced bronchospasm (prevention): Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation): 2 inhalations 5 minutes prior to exercise (NAEPP 2007)

Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]: 2 inhalations 30 minutes prior to exercise

Dry powder inhaler (200 mcg/inhalation): Ventolin Diskus [Canadian product]: 1 inhalation (200 mcg) 15 minutes before exercise

Hyperkalemia (off-label use): Inhalation: Nebulization solution: 10 to 20 mg over 10 minutes in combination with other recommended therapies (Putcha 2007; Wong 1999)

Dosing: Geriatric

Inhalation: Refer to adult dosing.

Bronchospasm (treatment): Oral, regular release: 2 mg 3 to 4 times daily; maximum: 8 mg 4 times daily

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. No dosage adjustment required in patients on hemodialysis, peritoneal dialysis, or CRRT (Aronoff 2007).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Asthma, acute exacerbation: Note: GINA guideline dosing is based on the 100 mcg/actuation salbutamol product (not available in US) (GINA 2018)

Outpatient (mild to moderate exacerbations):

Infants and Children ≤5 years:

Metered-dose inhaler: 90 mcg/actuation: Oral inhalation: 2 to 6 inhalations every 20 minutes for 2 to 3 doses (GINA 2018; NAEPP 2007); if initial response to 2 doses is good, administer 2 to 6 inhalations every 3 to 4 hours for 24 to 48 hours (NAEPP 2007); some experts suggest that if there is rapid response to initial therapy and no symptoms recur after 1 to 2 hours, therapy can be changed to every 3 to 4 hours as needed (GINA 2018); if initial response is good, but recurs after 3 to 4 hours, administer 2 to 3 inhalations every hour with close monitoring (GINA 2018).

Nebulization: 2.5 mg every 20 minutes for the first hour if needed; if there is rapid response to initial therapy after 1 to 2 hours, therapy can be changed to every 3 to 4 hours as needed (GINA 2018)

Children ≥6 years and Adolescents: Metered-dose inhaler: 90 mcg/actuation: Oral inhalation: 2 to 10 inhalations every 20 minutes for 2 to 3 doses during the first hour (GINA 2018; NAEPP 2007); if initial response to 2 doses is good, administer 2 to 6 inhalations every 3 to 4 hours for 24 to 48 hours (NAEPP 2007); some experts suggest that if there is rapid response to initial therapy and no symptoms recur after 1 to 2 hours, therapy can be changed to every 3 to 4 hours as needed (GINA 2018); if initial response is insufficient, reported doses after the first hour may vary from 4 to 10 inhalations every 3 to 4 hours up to 6 to 10 inhalations every 1 to 2 hours (GINA 2018)

Emergency care/hospital:

Infants and Children:

Metered-dose inhaler: 90 mcg/actuation: Oral inhalation: Limited data available in ages <4 years: 4 to 8 puffs every 20 minutes for 3 doses then every 1 to 4 hours (GINA 2018; NAEPP 2007).

Nebulization: Limited data in ages <2 years:

Intermittent: 0.15 mg/kg/dose (minimum dose: 2.5 mg/dose) every 20 minutes for 3 doses then 0.15 to 0.3 mg/kg/dose not to exceed 10 mg/dose every 1 to 4 hours (NAEPP 2007)

Continuous nebulization: Dosing regimens variable; optimal dosage not established:

Weight based:

NIH Guidelines: 0.5 mg/kg/hour (NAEPP 2007)

Alternate dosing: Limited data available: 0.3 mg/kg/hour has been used safely in the treatment of severe status asthmaticus in children (Papo 1993); higher doses of 3 mg/kg/hour ± 2.2 mg/kg/hour in children (n=19, mean age: 20.7 months ± 38 months) resulted in no cardiotoxicity (Katz 1993)

Fixed dose (Krebs 2013): Limited data available:

<20 kg: 10 mg/hour

≥20 kg: 20 mg/hour

Note: Dosing based on a retrospective, observational chart review evaluating standard protocol dosing (n=373) and historical dosing (n=393); study showed the continuous nebulized albuterol to be safe, but not superior to historical physician driven dosing (Krebs 2013).

Adolescents:

Metered-dose inhaler: 90 mcg/actuation: Oral inhalation: 4 to 8 puffs every 20 minutes for up to 4 hours, then every 1 to 4 hours (NAEPP 2007)

Nebulization:

NIH Guidelines (NAEPP 2007):

Intermittent: 2.5 to 5 mg every 20 minutes for 3 doses then 2.5 to 10 mg every 1 to 4 hours as needed

Continuous: 10 to 15 mg/hour

Alternate dosing (Krebs 2013): Limited data available:

<20 kg: 10 mg/hour

≥20 kg: 20 mg/hour

Note: Dosing based on a retrospective, observational chart review evaluating standard protocol dosing (n=373) and historical dosing (n=393); study showed the continuous nebulized albuterol to be safe, but not superior to historical physician driven dosing (Krebs 2013).

Asthma, maintenance therapy (nonacute) (NAEPP 2007): Oral inhalation:

Metered-dose inhaler: Infants, Children, and Adolescents: Limited data available in ages <4 years: 90 mcg/actuation: Oral inhalation: 2 inhalations every 4 to 6 hours as needed. Note: Not recommended for long-term daily maintenance treatment; regular use exceeding 2 days/week for symptom control (not prevention of exercise-induced bronchospasm) indicates the need for additional long-term control therapy.

Nebulization:

Infants and Children <5 years (limited data in ages <2 years): Oral inhalation: 0.63 to 2.5 mg every 4 to 6 hours as needed

Children ≥5 years and Adolescents: Oral inhalation: 1.25 to 5 mg every 4 to 8 hours as needed

Bronchospasm:

Metered-dose inhaler: Oral inhalation:

90 mcg/actuation: Children ≥4 years and Adolescents: 1 to 2 inhalations every 4 to 6 hours

100 mcg/actuation: Airomir [Canadian product]:

Children 6 to 11 years:

Acute treatment: 1 inhalation; additional inhalations may be necessary every 4 to 6 hours as needed if inadequate relief; however, patients should be advised to promptly consult health care provider or seek medical attention if no relief from acute treatment (additional inhalations or more frequent administration is not recommended)

Maintenance (in combination with corticosteroid therapy): 1 inhalation every 4 to 6 hours as needed; maximum daily dose: 4 inhalations/day

Children ≥12 years and Adolescents:

Acute treatment: 1 to 2 inhalations; additional inhalations may be necessary every 4 to 6 hours as needed if inadequate relief; however, patients should be advised to promptly consult health care provider or seek medical attention if no relief from acute treatment (additional inhalations or more frequent administration is not recommended)

Maintenance (in combination with corticosteroid therapy): 1 to 2 inhalations every 4 to 6 hours as needed; maximum daily dose: 8 inhalation/day

Dry powder inhaler: Oral inhalation:

90 mcg/inhalation: Children ≥4 years and Adolescents: 1 to 2 inhalations every 4 to 6 hours

200 mcg/inhalation: Ventolin Diskus [Canadian product]: Children ≥4 years and Adolescents:

Acute treatment: 1 inhalation as needed; maximum daily dose: 4 inhalations/day; patient should be advised to promptly consult health care provider or seek medical attention if prior dose fails to provide adequate relief or if control of symptoms lasts <3 hours

Maintenance (in combination with corticosteroid therapy): 1 inhalation every 4 to 6 hours; maximum daily dose: 4 inhalations/day

Nebulization: Oral inhalation:

Children ≥2 years and Adolescents:

10 to 15 kg: 1.25 mg 3 to 4 times daily

>15 kg: 2.5 mg 3 to 4 times daily

Oral: Note: Not the preferred route for treatment of asthma; inhalation via nebulization or MDI is preferred (GINA 2018; NAEPP 2007)

Immediate-release formulation (syrup, tablets):

Children 2 to 6 years: 0.1 mg/kg/dose (maximum dose: 2 mg/dose) 3 times daily; if desired response not achieved, gradually increase dose to 0.2 mg/kg/dose (maximum dose: 4 mg/dose) 3 times daily

Children >6 and Adolescents ≤14 years: 2 mg/dose 3 to 4 times daily; if desired response not achieved, gradually increase dose; maximum daily dose: 24 mg/day

Adolescents >14 years: 2 to 4 mg/dose 3 to 4 times daily; if desired response not achieved, gradually increase dose; maximum daily dose: 32 mg/day

Sustained-release formulation (tablets):

Children ≥6 years: 4 mg every 12 hours; if control not achieved may gradually increase dose; maximum daily dose: 24 mg/day

Adolescents: 8 mg every 12 hours; some patients achieve control with 4 mg every 12 hours; if control not achieved may gradually increase dose; maximum daily dose: 32 mg/day

Exercise-induced bronchospasm; prevention:

Metered-dose inhaler: Oral Inhalation:

90 mcg/actuation (AAAAI/ACAAI [Weiler 2016]; ATS [Parsons 2013]; NAEPP 2007): Limited data available in ages <4 years:

Infants and Children <5 years: 1 to 2 inhalations 5 to 20 minutes before exercising

Children ≥5 years and Adolescents: 2 inhalations 5 to 20 minutes before exercising

100 mcg/actuation: Airomir [Canadian product]:

Children 6 to 11 years: 1 inhalation 30 minutes prior to exercise

Children ≥12 years and Adolescents: 2 inhalations 30 minutes prior to exercise

Dry powder inhaler: 200 mcg/inhalation: Ventolin Diskus [Canadian product]: Oral Inhalation: Children ≥4 years and Adolescents: 1 inhalation 15 minutes before exercise

Hyperkalemia; adjunct therapy: Note: Albuterol should not be used as the sole agent for treating severe hyperkalemia, especially in patients with renal failure (McClure 1994). Limited data available: Nebulization: Oral inhalation:

Weight-based dose: Infants, Children, and Adolescents: 0.3 to 0.5 mg/kg/dose administered as a rapid nebulization or via continuous nebulization (Fuhrman 2011)

Fixed dose (McClure 1994): Children ≥5 years and Adolescents:

<25 kg: 2.5 mg nebulized over 10 minutes; dose may be repeated in 2 hours if necessary

≥25 kg: 5 mg nebulized over 10 minutes; dose may be repeated in 2 hours if necessary

Note: Doses as high as 10 mg or 20 mg have been suggested for use in adults (Weiner 1998; Weisberg 2008).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution when using high doses in patients with renal impairment. No dosage adjustment required, including patients on hemodialysis, peritoneal dialysis, or CRRT (Aronoff 2007).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling.

Use: Labeled Indications

Bronchospasm: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease

Exercise-induced bronchospasm: Prevention of exercise-induced bronchospasm

Use: Off-Label: Adult

  Hyperkalemia (Inhalation)Level of Evidence [A, G]

Data from small controlled trials and a systematic review support the use of nebulized albuterol in the treatment of hyperkalemia (Allon 1989, Batterink 2015, Mandelberg 1999). Additional trials may be necessary to further define the role of nebulized albuterol in this condition.

Based on AHA evidence-based guidelines, nebulized albuterol is recommended as adjuvant therapy for acute treatment of moderate to severe hyperkalemia (AHA [Vanden Hoek 2010]). Access Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Asthma:

Global Strategy for Asthma Management and Prevention (GINA), 2018 Update

NHLBI and NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

COPD:

ACCP/CTS, “Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease: American College of Chest Physicians and Canadian Thoracic Society Guideline,” 2014

Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease, 2007 Update

GOLD 2018 Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, 2018

Exercise-induced Bronchoconstriction:

AAAAI and ACAAI, “Exercise-induced Bronchoconstriction,” Update – 2016

Administration: IV

Infusion solution [Canadian product]: Do not inject undiluted. Reduce concentration by at least 50% before infusing. Administer as a continuous infusion via infusion pump.

Administration: Oral

Do not crush or chew extended release tablets.

Administration: Inhalation

Dry powder inhalers:

ProAir Digihaler, ProAir RespiClick: Inhaler device is breath-actuated; does not require priming. Do not use with spacer or volume holding chamber. Keep inhaler clean and dry by wiping with dry cloth or tissue as needed; do not wash or put any part of inhaler in water.

Ventolin Diskus [Canadian product]: For oral inhalation route only. To activate Diskus, patient should slide lever using the thumb grip away from them as far as it will go (click should be heard). Before inhaling the dose, breathe out fully; do not exhale into the Diskus device. Bring mouthpiece to lips and inhale steadily and deeply through the Diskus; hold breath for about 10 seconds or for as long as comfortable and exhale slowly. To close Diskus slide thumb grip back as far as it will go towards its original position. To prevent a wasted dose, the lever should not be manipulated until administration of next dose. Diskus counts down from 60 to 1 and when 5 doses remain the numbers appear in red. Diskus should be kept dry.

Metered-dose inhalers: Shake well before use; prime prior to first use, and whenever inhaler has not been used for >2 weeks or when it has been dropped, by releasing 3 to 4 test sprays into the air (away from face). Airomir Canadian product labeling recommends releasing a minimum of 4 test sprays when priming. HFA inhalers should be cleaned with warm water at least once per week; allow to air dry completely prior to use. A spacer device or valved holding chamber is recommended for use with metered-dose inhalers.

Nebulization solution: Concentrated solution should be diluted prior to use; adjust nebulizer flow to deliver dosage over 5 to 15 minutes; avoid contact of the dropper tip (multidose bottle) with any surface, including the nebulizer reservoir and associated ventilator equipment. Blow-by administration is not recommended; use a mask device if patient unable to hold mouthpiece in mouth for administration.

Administration: Pediatric

Oral inhalation: In infants and children <4 years, a face mask with either the metered-dose inhaler or nebulizer is recommended (GINA 2018; NAEPP 2007)

Inhalation, aerosol: Metered-dose inhaler: Shake well before use; prime the inhaler prior to first use and whenever it has not been used for >2 weeks or when it has been dropped by releasing 3 to 4 test sprays into the air away from the face. Use spacer for children <5 years of age and consider adding a face mask for infants and children <4 years of age (GINA 2018). HFA inhalers should be cleaned with warm water at least once per week; allow to air dry completely prior to use.

Inhalation, powder: Dry powder inhaler: Inhaler device is breath-actuated; does not require priming. Do not use with spacer or volume holding chamber. Keep inhaler clean and dry by wiping with dry cloth or tissue as needed; do not wash or put any part of inhaler in water.

Nebulization: Concentrated solutions (≥0.5%) should be diluted prior to use; adjust nebulizer flow to deliver dosage over 5 to 15 minutes; avoid contact of the dropper tip (multidose bottle) with any surface, including the nebulizer reservoir and associated ventilator equipment. For continuous nebulization, the total amount of fluid delivered is determined by nebulizer delivery device; usually 25 to 30 mL per 1 hour of nebulization, protocols may vary by institution (Hegenbarth 2008). Blow-by administration is not recommended; use a mask device if patient is unable to hold mouthpiece in mouth for administration.

Oral: Do not crush or chew extended-release tablets.

Storage/Stability

Metered-dose inhalers (HFA aerosols): Store at 15°C to 25°C (59°F to 77°F). Do not store at temperature >120°F. Do not puncture. Do not use or store near heat or open flame.

Ventolin HFA: Discard when counter reads 000 or 12 months after removal from protective pouch, whichever comes first. Store with mouthpiece down.

Dry powder inhalers:

ProAir Digihaler, ProAir RespiClick: Store between 15°C and 25°C (59°F and 77°F). Avoid exposure to extreme heat, cold, or humidity. Discard 13 months after opening the foil pouch, or when the counter displays 0, whichever comes first.

Ventolin Diskus [Canadian product]: Store at ≤30°C (86°F). Keep in a dry place. Protect from frost and light. Diskus is nonrefillable and should be discarded after all doses have been administered.

Infusion solution [Canadian product]: Ventolin IV: Store at 15°C to 30°C (59°F to 86°F). Protect from light. After dilution, discard unused portion after 24 hours.

Nebulization solution: Store at 2°C to 25°C (36°F to 77°F). Do not use if solution changes color or becomes cloudy. Products packaged in foil should be used within 1 week (or according to the manufacturer’s recommendations) if removed from foil pouch.

Syrup: Store at 20°C to 25°C (68°F to 77°F).

Tablet: Store at 20°C to 25°C (68°F to 77°F).

Tablet, extended release: Store at 20°C to 25°C (68°F to 77°F).

Preparation for Administration: Adult

Nebulization solution: 0.5% solution: Dilute 0.25 mL (1.25 mg dose) or 0.5 mL (2.5 mg) of solution to a total of 3 mL with normal saline; also compatible with cromolyn or ipratropium nebulizer solutions.

IV [Canadian product]: Dilute 5 mg in 500 ml of NS, D5W, or D5NS. Use within 24 hours.

Preparation for Administration: Pediatric

Solution for nebulization: 0.5% solution: Dilute 0.25 mL (1.25 mg dose) or 0.5 mL (2.5 mg dose) of solution to a total of 3 mL with normal saline; also compatible with cromolyn or ipratropium nebulizer solutions

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, tremor, pharyngitis, back pain, aches, pains, or rhinorrhea. Have patient report immediately to prescriber signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), angina, abnormal heartbeat, tachycardia, severe anxiety, severe headache, severe dizziness, passing out, vision changes, signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), painful urination, or difficult urination (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to albuterol or any component of the formulation; severe hypersensitivity to milk proteins (dry powder inhalers).

Documentation of allergenic cross reactivity for sympathomimetics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling):

Injection: Ventolin: Hypersensitivity to albuterol or any component of the formulation; tachyarrhythmias; risk of abortion during first or second trimester

Inhalation: Tocolytic use in patients at risk of premature labor or threatened abortion

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents (may be fatal); this should be distinguished from inadequate response.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, oropharyngeal edema), including anaphylaxis, have been reported.

Disease-related concerns:

• Asthma: Albuterol is a short-acting beta2-agonist (SABA) that should be used as needed for quick relief of asthma symptoms. Based on a step-wise treatment approach using asthma guidelines, monotherapy without concurrent use of a long-term controller medication should only be reserved for patients with mild, intermittent forms of asthma without the presence of risk factors (Step 1 and/or exercise-induced) (GINA 2018; NAEPP 2007).

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension, heart failure); beta-agonists may produce ECG changes (flattening of the T wave, prolongation of the QTc interval, ST segment depression) and/or cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias. In a scientific statement from the American Heart Association, albuterol has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate to major) (AHA [Page 2016]).

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose and aggravate preexisting diabetes and ketoacidosis.

• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.

• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Oral inhalation: Use spacer for children <5 years of age and consider adding a face mask for infants and children <4 years of age.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Lactose: Dry powder inhalers may contain lactose; hypersensitivity reactions (eg, anaphylaxis, angioedema, pruritus, and rash) have been reported in patients with milk protein allergy.

Other warnings/precautions:

• Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler.

Geriatric Considerations

Because of its minimal effect on beta1-receptors and its relatively long duration of action, albuterol is a rational choice in elderly when a beta-agonist is indicated. Elderly patients may find it beneficial to utilize a spacer device when using a metered dose inhaler. Oral use should be avoided due to adverse effects.

Warnings: Additional Pediatric Considerations

CNS stimulation, hyperactivity, and insomnia occur more frequently in younger children than in adults. In children receiving oral albuterol therapy, erythema multiforme and Stevens-Johnson syndrome have been reported (rare). Outbreaks of lower respiratory tract colonization and infection have been attributed to contaminated multidose albuterol bottle.

Pregnancy Considerations

Albuterol crosses the placenta (Boulton 1997).

Congenital anomalies (cleft palate, limb defects) have rarely been reported following maternal use during pregnancy. Multiple medications were used in most cases, no specific pattern of defects has been reported, and no relationship to albuterol has been established. The amount of albuterol available systemically following inhalation is significantly less in comparison to oral doses.

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Albuterol is the preferred short acting beta-agonist when treatment for asthma is needed during pregnancy (ACOG 2008; GINA 2018; NAEPP 2007). If high doses are required during labor and delivery, monitoring of glucose concentrations in the newborn for 24 hours is recommended, especially in preterm infants (GINA 2018).

Albuterol may affect uterine contractility. Maternal pulmonary edema and other adverse events have been reported when albuterol was used for tocolysis. Albuterol is not approved for use as a tocolytic; use caution when needed to treat bronchospasm in pregnant women.

Data collection to monitor pregnancy and infant outcomes following exposure to asthma medications is ongoing. For additional information contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertobaby.org/pregnancystudies/.

Breast-Feeding Considerations

It is not known if albuterol is present in breast milk.

The amount of albuterol available systemically following inhalation is significantly less in comparison to oral doses. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother. Women with asthma should be encouraged to breastfeed (GINA 2018). Use of albuterol is generally considered acceptable in breastfeeding women when used in usual doses (WHO 2002).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Incidence of adverse effects is dependent upon age of patient, dose, and route of administration. Frequency not always defined.

>10%:

Central nervous system: Excitement (children and adolescents 2 to 14 years: 20%), nervousness (4% to 15%)

Neuromuscular & skeletal: Tremor (≥5% to 38%; frequency increases with age)

Respiratory: Upper respiratory tract infection (≥5% to 21%), rhinitis (5% to 16%), bronchospasm (8% to 15%; exacerbation of underlying pulmonary disease), pharyngitis (14%), exacerbation of asthma (11% to 13%)

1% to 10%:

Cardiovascular: Tachycardia (≤7%), hypertension (1% to 3%), chest pain (<3%), edema (<3%), extrasystoles (<3%), chest discomfort, flushing, palpitations

Central nervous system: Shakiness (children and adolescents 6 to 14 years: 9%), headache (3% to 7%), dizziness (<7%), insomnia (1% to 3%), anxiety (<3%), ataxia (<3%), depression (<3%), drowsiness (<3%), rigors (<3%), voice disorder (<3%), hyperactive behavior (children and adolescents 6 to 14 years: 2%), malaise (2%), pain (2%), migraine (≤2%), emotional lability (1%), fatigue (1%), restlessness, vertigo

Dermatologic: Diaphoresis (<3%), skin rash (<3%), urticaria (≤2%), pallor (children 2 to 6 years: 1%)

Endocrine & metabolic: Increased serum glucose (10%), diabetes mellitus (<3%)

Gastrointestinal: Nausea (2% to 10%), vomiting (3% to 7%), unpleasant taste (inhalation site, 4%), gastroenteritis (3%), increased appetite (children and adolescents 6 to 14 years: 3%), viral gastroenteritis (1% to 3%), diarrhea (<3%), eructation (<3%), flatulence (<3%), glossitis (<3%), xerostomia (<3%), gastrointestinal signs and symptoms (children 2 to 6 years: 2%), dyspepsia (1% to 2%), anorexia (children 2 to 6 years: 1%)

Genitourinary: Urinary tract infection (≤3%), difficulty in micturition

Hematologic & oncologic: Decreased hematocrit (7%), decreased hemoglobin (7%), decreased white blood cell count (4%), lymphadenopathy (3%)

Hepatic: Increased serum ALT (5%), increased serum AST (4%)

Hypersensitivity: Hypersensitivity reaction (3% to 6%)

Infection: Cold symptoms (3%), infection (<3%; skin/appendage: ≤2%)

Local: Application site reaction (HFA inhaler: 6%)

Neuromuscular & skeletal: Muscle cramps (1% to 7%; frequency increases with age), musculoskeletal pain (3% to 5%), back pain (2% to 4%), hyperkinesia (≤4%), leg cramps (<3%)

Ophthalmic: Conjunctivitis (children 2 to 6 years: 1%)

Otic: Otitis media (≤4%), ear disease (<3%), otalgia (<3%), tinnitus (<3%)

Respiratory: Throat irritation (10%), viral upper respiratory tract infection (7%), respiratory tract disease (6%), nasopharyngitis (≥5%; children: 2%), oropharyngeal pain (≥5%; children: 2%), sinusitis (≥5%), upper respiratory tract inflammation (5%), cough (≥3%), flu-like symptoms (3%), dyspnea (<3%), laryngitis (<3%), oropharyngeal edema (<3%), pulmonary disease (<3%), bronchitis (≥2%), increased bronchial secretions (2%), wheezing (1% to 2%), epistaxis (children and adolescents 6 to 14 years: 1%), nasal congestion (1%), sinus headache (1%)

Miscellaneous: Fever (≥5% to 6%), accidental injury (<3%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angina pectoris, angioedema, atrial fibrillation, dysgeusia, exacerbation of diabetes mellitus, gag reflex, hoarseness, hyperglycemia, hypokalemia, hypotension, irritability, ketoacidosis, lactic acidosis, metabolic acidosis, muscle spasm (children and adolescents 6 to 14 years), mydriasis (children and adolescents 6 to 14 years), oropharyngeal irritation, paradoxical bronchospasm, peripheral vasodilation, stomach pain (children and adolescents 6 to 14 years), supraventricular tachycardia, tongue ulcer, weakness

Toxicology
Metabolism/Transport Effects

None known.

Drug Interactions 

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk – Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk – Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Test Interactions

Increased renin (S), increased aldosterone (S)

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium, serum creatinine; asthma symptoms; arterial or capillary blood gases (if patients condition warrants)

Advanced Practitioners Physical Assessment/Monitoring

For inpatient care, monitor vital signs at beginning of therapy and periodically throughout. Evaluate effectiveness of therapy (relief of airway obstruction).

Nursing Physical Assessment/Monitoring

Evaluate effectiveness of therapy (relief of airway obstruction). For inpatient care, monitor vital signs and lung sounds prior to and periodically during therapy.

Product Availability

ProAir Digihaler: FDA approved December 2018. ProAir Digihaler will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with health care systems and in limited geographies, in order to gather real-world experience. A national launch is planned for 2020.

Dosage Forms Considerations

ProAir Digihaler 0.65 g inhaler, ProAir HFA 8.5 g canisters, ProAir RespiClick 0.65 g inhaler, Proventil HFA 6.7 g canisters, and Ventolin HFA 18 g canisters contain 200 inhalations. Ventolin HFA 8 g canisters contain 60 inhalations. The ProAir Digihaler is a digital inhaler which detects, records, and stores inhaler events, including peak inspiratory flow rate, and transmits data to a mobile application for inhaler use information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol Powder Breath Activated, Inhalation:

ProAir RespiClick: 90 mcg/actuation (1 ea) [contains milk protein]

Aerosol Solution, Inhalation:

ProAir HFA: 90 mcg/actuation (8.5 g)

Proventil HFA: 90 mcg/actuation (6.7 g)

Ventolin HFA: 90 mcg/actuation (8 g, 18 g)

Generic: 90 mcg/actuation (8.5 g, 18 g)

Nebulization Solution, Inhalation:

Generic: 0.63 mg/3 mL (3 mL); 0.083% [2.5 mg/3 mL] (3 mL); 0.5% [2.5 mg/0.5 mL] (20 mL)

Nebulization Solution, Inhalation [preservative free]:

Generic: 0.63 mg/3 mL (3 mL); 1.25 mg/3 mL (3 mL); 0.083% [2.5 mg/3 mL] (3 mL); 0.5% [2.5 mg/0.5 mL] (1 ea)

Syrup, Oral:

Generic: 2 mg/5 mL (473 mL)

Tablet, Oral:

Generic: 2 mg, 4 mg

Tablet Extended Release 12 Hour, Oral:

VoSpire ER: 4 mg [DSC] [contains fd&c blue #1 aluminum lake, fd&c yellow #10 aluminum lake]

VoSpire ER: 8 mg [DSC]

Generic: 4 mg, 8 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol Powder Breath Activated, Inhalation:

Ventolin Diskus: 200 mcg/actuation (1ea, 60ea) [contains LACTOSE, MILK PROTEIN]

Aerosol Solution, Inhalation:

Airomir: 90 mcg/actuation (3.7gm, 6.7gm) [contains ALCOHOL, USP]

Ventolin HFA: 90 mcg/actuation (17gm)

Generic: 100 mcg/actuation (6.7gm, 15ml); 90 mcg/actuation (1ea)

Liquid, Oral:

Generic: 0.4 mg/mL (250ml)

Nebulization Solution, Inhalation:

Ventolin: 0.5% [2.5 mg/0.5 mL] (10ml, 100ml)

Ventolin PF: 0.1% (2.5ml); 0.2% (2.5ml)

Generic: 0.5 mg/mL (2.5ml, 10ml, 50ml, 100ml); 1 mg/mL (1ml[DSC], 2.5ml); 2 mg/mL (1ml[DSC], 2.5ml); 0.1% (1ea, 2.5ml, 10ml, 20ml, 50ml, 100ml); 0.2% (2.5ml, 10ml, 50ml, 100ml); 0.5% [2.5 mg/0.5 mL] (2.5ml[DSC], 10ml, 250ml)

Solution, Intravenous:

Ventolin: 1 mg/mL (5ml)

Tablet, Oral:

Generic: 2 mg [DSC], 4 mg [DSC]

Anatomic Therapeutic Chemical (ATC) Classification
  • R03AC02
  • R03CC02
Generic Available (US)

May be product dependent

Pricing: US

Aerosol powder (ProAir RespiClick Inhalation)

108 (90 Base) mcg/ACT (per each): $72.84

Aerosol solution (Albuterol Sulfate HFA Inhalation)

108 (90 Base) mcg/ACT (per gram): $8.71

Aerosol solution (ProAir HFA Inhalation)

108 (90 Base) mcg/ACT (per gram): $9.17

Aerosol solution (Proventil HFA Inhalation)

108 (90 Base) mcg/ACT (per gram): $14.28

Aerosol solution (Ventolin HFA Inhalation)

108 (90 Base) mcg/ACT (per gram): $3.31

Nebulization (Albuterol Sulfate Inhalation)

0.63 mg/3 mL (per mL): $0.55 – $0.60

1.25 mg/3 mL (per mL): $0.55 – $0.60

(2.5 MG/3ML) 0.083% (per mL): $0.27 – $0.52

(5 MG/ML) 0.5% (per each): $0.90 – $1.00

Syrup (Albuterol Sulfate Oral)

2 mg/5 mL (per mL): $0.07 – $0.13

Tablet, 12-hour (Albuterol Sulfate ER Oral)

4 mg (per each): $1.78

8 mg (per each): $3.34

Tablets (Albuterol Sulfate Oral)

2 mg (per each): $5.87 – $7.05

4 mg (per each): $5.87 – $5.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Relaxes bronchial smooth muscle by action on beta2-receptors with little effect on heart rate

Pharmacodynamics/Kinetics

Onset of action:

Nebulization solution: ≤5 minutes

Oral inhalationDPI: 5.7 minutes (median); MDI: 5.4 to 8.2 minutes (median)

Oral: Immediate release: ≤30 minutes

Duration of action:

Nebulization solution: 3 to 6 hours

Oral inhalationDPI: ~2 hours (median); MDI: ~4 to 6 hours

Oral: Immediate release: 6 to 8 hours; Extended release: Up to 12 hours

Protein binding: 10%

Metabolism: Hepatic to an inactive sulfate

Half-life elimination:

Oral inhalation: 3.8 to ~5 hours

Oral: Immediate release: 5 to 6 hours; Extended release: 9.3 hours

Time to peak, serum:

Nebulization solution30 minutes

Oral inhalation: DPI: 30 minutes; MDI: 25 minutes (mean)

Oral: Immediate release: ≤2 hours; Extended release: 6 hours

Time to peak, FEV1

Nebulization solution~1 to 2 hours

Oral inhalation: DPI: Within 30 minutes; MDI: 47 minutes

Oral: Immediate release: 2 to 3 hours

Excretion: Urine (80% to 100% [oral inhalation]; 76% over 3 days [60% metabolite; oral]); Feces (<20% [oral inhalation]; 4% [oral])

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: There was a 67% decline in albuterol clearance in patients with CrCl 7 to 53 mL/minute.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation)

Effects on Bleeding

No information available to require special precautions

Index Terms

AccuNeb; Albuterol Sulfate; ProAir Digihaler; ProAir RespiClick; Salbutamol; Salbutamol Sulphate; Volmax

FDA Approval Date
May 01, 1981
References

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ProAir RespiClick (albuterol) [prescribing information]. Horsham, PA: Teva Respiratory; August 2018.

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Brand Names: International

Aero-Vent (PH); Aerolin (BR, CN, GR, QA); Aeromol (TH); Airmax (CO); Airomir (AU, BE, DK, ES, FI, FR, GB, LU, NO, SE, TW, UY); Asmacaire (PH); Asmadil (BF, BJ, CI, ET, GH, GM, GN, JO, KE, LR, MA, ML, MR, MU, MW, NE, NG, SA, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Asmalat (LB); Asmalin Pulmoneb (PH); Asmanol (ZW); Asmatol (AR); Asmavent (ZW); Asmed (ZW); Asmidon (JP); Asmol (SG); Asmol CFC-Free (AU); Assal (MX); Asthalin (IN, LB, LK, NZ, RO, ZW); Asthalin HFA (HK); Asthalin Inhaler (TZ); Asthavent (AE, ZA); Asvimol (PH); Avedox-FC (MX); Bajapres (CO); Bemin (EC); Bresaltec (CR, DO, GT, HN, NI, PA, SV); Brodil (BD); Brodil HFA (BD); Broncho-Spray (DE); Broncholin S (EG); Bronchosol (TH); Bronchoterol (EG); Broncolin (MY, PH); Brondisal (ID); Bropil (CL); Brytolin (PH); Butalin (BH, ET, JO, LB, SA); Butamol (AR, AU, PY); Butavent (MY); Buto-Air (ES, MT); Buto-Asma (BG, HK, PK, TH); Butotal (CN); Buventol (AE, AT, CZ, EE, LV, NO, SG, TW); Buventol Easyhaler (TH); Ciplabutol (EC); Cotran (TW); Cybutol (LK); Derihaler (ET, LK); Durasol CR (LK); Easyhaler Salbutamol (GB, IE); Ecosal (BG, HR); Etinoline (CN); Farcolin (AE, CY, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Farmarest (CR, DO, GT, HN, NI, PA, SV); Grafalin (ID); Hivent DS (PH); Huma-Salmol (HU); Inbumed (MX); Lebasma (ET); Libretin (PH); Medolin (SG); Mozal (TW); Nebsal (CR, DO, GT, HN, NI, PA, SV); Neoventil (BH); Respigen (NZ); Sabutal (TW); Salamol (CH, IE, MY); Salapin (MT, NZ); Salbetol (IN); Salbo 2 (LK); Salbron (ID); Salbuflo (LK, PH); Salbul (IE); Salbulin (LU); Salbutalan (MX); Salbutamol (HU); Salbutamol-GW (HU); Salbutan (VE); Salbutin (AE, CY, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Salbutol (KR); Salbutrim (IL); Salbuvent (PE); Salmaplon (IN); Salmolin (BD); Salomol (TW); Saltam (ID); Solia (TH); Sultanol (AT, DE, JP); Synvent HFA (HK); Teoden (BR); Unibron (MX); Velutine (ID); Venalax (PH); Venderol (SG); Venetlin (JP); Ventamol (ID); Venterol (TH); Venteze (ZA, ZW); Ventilan (CO, PT); Ventilastin (LT, RO); Ventilastin Novolizer (DE, FR); Ventodisk (LU); Ventol (AE, BH, CY, ET, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ventolin (AE, AR, AU, BE, BF, BG, BH, BJ, BS, BZ, CH, CI, CL, CU, CY, CZ, DO, EE, EG, ES, ET, GH, GM, GN, GT, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, IS, IT, JM, JO, KE, KR, KW, LB, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NZ, OM, PA, PE, PH, PK, PL, PR, PY, QA, RO, RU, SA, SC, SD, SI, SK, SL, SN, SR, SV, SY, TH, TN, TR, TT, TW, TZ, UA, UG, UY, YE, ZM, ZW); Ventolin CFC-Free (AU); Ventolin HFA (BB, BM); Ventoline (DK, FI, FR, NO, SE); Ventylor (UA); Volmax (AE, CY, EC, HU, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Zenmolin (AE, CY, HK, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Zibil (MX); Zomm (PY)

Albuterol (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(al BYOO ter ole)

Brand Names: US

ProAir HFA; ProAir RespiClick; Proventil HFA; Ventolin HFA; VoSpire ER [DSC]

Brand Names: Canada

Airomir; Ventolin Diskus; Ventolin HFA; Ventolin I.V. Infusion; Ventolin Nebules P.F.; Ventolin Respirator

What is this drug used for?
  • It is used to open the airways in lung diseases where spasm may cause breathing problems.
  • It is used to prevent exercise-induced breathing problems.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to this drug or any part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are using another drug like this one.
  • If you are breast-feeding or plan to breast-feed.
  • All dry powder inhaler products:
  • If you have a milk allergy.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take more of this drug or use it more often than you have been told. Deaths have happened when too much of this drug was taken. Talk with your doctor.
  • Call your doctor right away if your normal dose does not work well, if your signs get worse, or if you need to use this drug more often than normal.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • If you are taking digoxin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • Use with care in children. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very nervous and excitable.
  • This drug may sometimes cause severe breathing problems. This may be life-threatening. When this happens with an inhaler or with liquid for breathing in, most of the time it happens right after a dose and after the first use of a new canister or vial of this drug. If you have trouble breathing, breathing that is worse, wheezing, or coughing, get medical help right away.
  • All dry powder inhaler products:
  • Pain when passing urine.
  • Trouble passing urine.
  • All oral products:
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • All products:
  • Feeling nervous and excitable.
  • Headache.
  • Dizziness.
  • Upset stomach or throwing up.
  • Shakiness.
  • All products for breathing in:
  • Throat irritation.
  • Runny nose.
  • All dry powder inhaler products:
  • Back pain.
  • Aches and pains. Mild pain drugs may help.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All inhaler products:
  • For breathing into the lungs.
  • If you are using more than 1 inhaled drug, ask the doctor which drug to use first.
  • If working out or playing sports causes signs, use right before doing it.
  • Have your inhaler use checked with your doctor at each visit. Read and follow facts on how to use the inhaler. Make sure you use the inhaler the right way.
  • Follow how to clean carefully.
  • Put the cap back on after you are done using your dose.
  • Inhaler (aerosol):
  • Shake well before use.
  • You will need to prime the inhaler before first use. You will also need to prime the inhaler if it has not been used for some time. Be sure you know when you need to prime the inhaler and how to do it. Talk with your doctor or pharmacist if you have questions.
  • Some inhalers need to be primed if dropped. Ask your doctor or pharmacist if you are not sure.
  • A spacer may be used with the inhaler for easy use.
  • This inhaler may have a dose counter to keep track of how many doses are left. If it does, throw the inhaler away when the dose counter has a 0 in it.
  • All dry powder inhaler products:
  • Close the device after each dose. Do not open the device unless a dose is being used.
  • Do not take the device apart or wash it. Do not use it with a spacer. Do not breathe out into the device.
  • Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.
  • This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when the dose counter has a 0 in it, 13 months after opening the foil pouch, or after the expiration date, whichever comes first.
  • Digital dry powder inhaler:
  • This product keeps track of inhaler event information and may be used with a smartphone app. This product can be used without being connected to the smartphone app. Be sure you know how to use this product and the smartphone app. Follow what the doctor has told you to do. Read the package insert for details. If you have questions, talk with the doctor.
  • Liquid for breathing in:
  • For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Do not mix other drugs in nebulizer.
  • All oral products:
  • Take with or without food.
  • Extended-release tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Take with a full glass of water.
  • Oral liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • If you use this drug on a regular basis, use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.
  • Many times this drug is used on an as needed basis. Do not use more often than told by the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • All inhaler products:
  • Protect from cold.
  • If the inhaler comes in a foil pouch, store in the foil pouch until ready for use.
  • Inhaler (aerosol):
  • Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
  • Throw away the inhaler after the most number of sprays have been used, even if it feels like there is more drug in the can.
  • Store with the mouthpiece down.
  • All dry powder inhaler products:
  • Protect from heat.
  • Liquid for breathing in:
  • Store unused containers in foil pouch until use.
  • Check how long vials may be stored once the pouch has been opened.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Albuterol (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(al BYOO ter ole)

Brand Names: US

ProAir HFA; ProAir RespiClick; Proventil HFA; Ventolin HFA; VoSpire ER [DSC]

Brand Names: Canada

Airomir; Ventolin Diskus; Ventolin HFA; Ventolin I.V. Infusion; Ventolin Nebules P.F.; Ventolin Respirator

What is this drug used for?
  • It is used to open the airways in lung diseases where spasm may cause breathing problems.
  • It is used to prevent exercise-induced breathing problems.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is using another drug like this one.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • All dry powder inhaler products:
  • If your child is allergic to milk, talk with the doctor.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Do not give more of this drug or have your child use it more often than you were told by the doctor. Deaths have happened when too much of this drug was taken. Talk with the doctor.
  • Call the doctor right away if your child’s normal dose does not work well, if your child’s signs get worse, or if your child needs to use this drug more often than normal.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • If your child is taking digoxin, talk with your child’s doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • Use with care in children. Talk with the doctor.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very nervous and excitable.
  • This drug may sometimes cause severe breathing problems. This may be life-threatening. When this happens with an inhaler or with liquid for breathing in, most of the time it happens right after a dose and after the first use of a new canister or vial of this drug. If your child has trouble breathing, breathing that is worse, wheezing, or coughing, get medical help right away.
  • All dry powder inhaler products:
  • Pain when passing urine.
  • Trouble passing urine.
  • All oral products:
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All products:
  • Feeling nervous and excitable.
  • Headache.
  • Dizziness.
  • Upset stomach or throwing up.
  • Shakiness.
  • All products for breathing in:
  • Nose or throat irritation.
  • Runny nose.
  • All dry powder inhaler products:
  • Back pain.
  • Aches and pains. Mild pain drugs may help.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All inhaler products:
  • For breathing into the lungs.
  • If your child is using more than 1 inhaled drug, ask your child’s doctor which inhaled drug to give first.
  • If working out or playing sports causes your child signs, give right before your child does it.
  • Check your child’s inhaler use with the doctor at each visit. Read and follow facts on how to use the inhaler. Make sure your child uses the inhaler the right way.
  • Follow how to clean carefully.
  • Put the cap back on after your child is done using a dose.
  • Inhaler (aerosol):
  • Shake the inhaler well before use.
  • You will need to prime the inhaler before first use. You will also need to prime the inhaler if it has not been used for some time. Be sure you know when you need to prime the inhaler and how to do it. Talk with your doctor or pharmacist if you have questions.
  • Some inhalers need to be primed if dropped. Ask your doctor or pharmacist if you are not sure.
  • A spacer may be used with the inhaler for easy use.
  • This inhaler may have a dose counter to keep track of how many doses are left. If it does, throw the inhaler away when the dose counter has a 0 in it.
  • All dry powder inhaler products:
  • Close the device after each dose. Do not open the device unless a dose is being used.
  • Do not take the device apart or wash it. Do not use it with a spacer. Be sure your child does not breathe out into the device.
  • Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.
  • This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when the dose counter has a 0 in it, 13 months after opening the foil pouch, or after the expiration date, whichever comes first.
  • Digital dry powder inhaler:
  • This product keeps track of inhaler event information and may be used with a smartphone app. This product can be used without being connected to the smartphone app. Be sure you know how to use this product and the smartphone app. Follow what the doctor has told you to do. Read the package insert for details. If you have questions, talk with the doctor.
  • Liquid for breathing in:
  • For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Do not mix other drugs in nebulizer.
  • All oral products:
  • Give this drug with or without food.
  • Extended-release tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Give this drug with a full glass of water.
  • Oral liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • If your child uses this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • All inhaler products:
  • Protect from cold.
  • If the inhaler comes in a foil pouch, store in the foil pouch until ready for use.
  • Inhaler (aerosol):
  • Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
  • Throw away the inhaler after the most number of sprays have been used, even if it feels like there is more drug in the can.
  • Store with the mouthpiece down.
  • All dry powder inhaler products:
  • Protect from heat.
  • Liquid for breathing in:
  • Store unused containers in foil pouch until use.
  • Check how long vials may be stored once the pouch has been opened.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.