(al BYOO ter ole)
Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease; prevention of exercise-induced bronchospasm
Inhalation, Oral: Hypersensitivity to albuterol or any component of the formulation; severe hypersensitivity to milk proteins (powder for inhalation).
Injection [Canadian product]: Hypersensitivity to albuterol or any component of the formulation; tachyarrhythmias; risk of abortion during first or second trimester
Bronchospasm:
Metered-dose inhaler (90 mcg/actuation): Inhalation aerosol or powder: 2 inhalations every 4 to 6 hours as needed (NAEPP 2007)
Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]: Inhalation aerosol:
Acute treatment: 1 to 2 inhalations; additional inhalations may be necessary if inadequate relief however patients should be advised to promptly consult health care provider or seek medical attention if no relief from acute treatment
Maintenance: 1 to 2 inhalations 3 to 4 times daily (maximum: 8 inhalations daily)
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):
Metered-dose inhaler (90 mcg/actuation): Inhalation aerosol or powder: 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):
Metered-dose inhaler (90 mcg/actuation): Inhalation aerosol or powder: 2 inhalations 5 minutes prior to exercise (NAEPP 2007)
Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]: Inhalation aerosol: 2 inhalations 30 minutes prior to exercise
Inhalation: Refer to adult dosing.
Bronchospasm (treatment):Oral, regular release: 2 mg 3 to 4 times daily; maximum: 8 mg 4 times daily
Bronchospasm:
Metered-dose inhaler (90 mcg/actuation) (NAEPP 2007): Inhalation aerosol or powder: Quick relief: Children and Adolescents: Refer to adult dosing.
Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]: Inhalation aerosol:
Children 6 to 11 years:
Acute treatment: 1 inhalation; additional inhalations may be necessary if inadequate relief; however, patients should be advised to promptly consult health care provider or seek medical attention if no relief from acute treatment
Maintenance: 1 inhalation; may increase to maximum of 1 inhalation 4 times daily
Children ≥12 years and Adolescents: Refer to adult dosing.
Nebulization solution:
Manufacturers recommendations:
Children 2 to 12 years: 0.63 to 1.25 mg 3 to 4 times daily as needed
Children ≥12 years and Adolescents: 2.5 mg 3 to 4 times daily as needed
NIH Guidelines 2007: Quick relief:
Children ≤4 years: 0.63 to 2.5 mg every 4 to 6 hours as needed
Children 5 to 11 years: 1.25 to 5 mg every 4 to 8 hours as needed
Children ≥12 years and Adolescents: Refer to adult dosing.
Oral: Note: Oral is not the preferred route for treatment of asthma; inhalation via nebulization or MDI is preferred (NAEPP 2007).
Regular release:
Children 2 to 6 years: 0.1 to 0.2 mg/kg/dose 3 times daily (maximum: 12 mg daily)
Children 6 to 12 years: 2 mg/dose 3 to 4 times daily (maximum: 24 mg daily)
Children >12 years and Adolescents: 2 to 4 mg/dose 3 to 4 times daily (maximum: 32 mg daily)
Extended release:
Children 6 to 12 years: 4 mg every 12 hours (maximum: 24 mg daily)
Children >12 years and Adolescents: 8 mg every 12 hours (maximum: 32 mg daily)
Exacerbation of asthma (acute, severe) (NAEPP 2007):
Metered-dose inhaler (90 mcg/actuation): Inhalation aerosol or powder:
Children <12 years: 4 to 8 inhalations every 20 minutes for 3 doses, then every 1 to 4 hours as needed
Children ≥12 years and Adolescents: 4 to 8 inhalations every 20 minutes for up to 4 hours, then every 1 to 4 hours as needed
Nebulization solution:
Children <12 years: 0.15 mg/kg (minimum: 2.5 mg) every 20 minutes for 3 doses, then 0.15 to 0.3 mg/kg (maximum: 10 mg) every 1 to 4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization
Children ≥12 years and Adolescents: 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):
Metered-dose inhaler (90 mcg/actuation): Inhalation aerosol or powder:
Children ≤4 years: 1 to 2 inhalations 5 minutes prior to exercise (NAEPP 2007)
Children >4 years and Adolescents: 2 inhalations 5 minutes prior to exercise (NAEPP 2007)
Metered-dose inhaler (100 mcg/actuation): Airomir [Canadian product]: Inhalation aerosol:
Children 6 to 11 years: 1 inhalation 30 minutes prior to exercise
Children ≥12 years and Adolescents: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling; use with caution. No dosage adjustment required in patients on hemodialysis, peritoneal dialysis, or CRRT (Aronoff 2007).
There are no dosage adjustments provided in the manufacturers labeling.
Solution for nebulization: To prepare a 2.5 mg dose, dilute 0.5 mL 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/ 5 mL ampul in 500 mL of a compatible solution (final concentration: 10 mcg/mL). Use within 24 hours.
Infusion solution [Canadian product]: Do not inject undiluted. Reduce concentration by at least 50% before infusing. Administer as a continuous infusion via infusion pump.
Inhalation powder: 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.
Metered-dose inhalers:
Inhalation aerosol: 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.
Inhalation powder: 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 solution: Concentrated solution should be diluted prior to use. Blow-by administration is not recommended, use a mask device if patient unable to hold mouthpiece in mouth for administration.
Oral: Do not crush or chew extended release tablets.
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.
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.
Inhalation powder: 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.
Solution for nebulization: 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 manufacturers 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)
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)
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]:
AccuNeb: 0.63 mg/3 mL (3 mL [DSC]); 1.25 mg/3 mL (3 mL [DSC])
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 [contains fd&c blue #1 aluminum lake, fd&c yellow #10 aluminum lake]
VoSpire ER: 8 mg
Generic: 4 mg, 8 mg
Intravenous solution: Stable in water for injection, NS, D5W, and D5NS when mixed in polyvinyl chloride (PVC) bags or glass bottles. Avoid addition of other medications to infusion solution.
AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. 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. 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. Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination
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. Consider therapy modification
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. 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. Avoid combination
MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification
Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium; asthma symptoms; arterial or capillary blood gases (if patients condition warrants)
Increased renin (S), increased aldosterone (S)
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%), hyperactivity (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 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/appendange: ≤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% (Limited to important or life-threatening): Anaphylaxis, atrial fibrillation, exacerbation of diabetes mellitus, gag reflex, glossitis, hyperglycemia, hypokalemia, hypotension, ketoacidosis, lactic acidosis, paradoxical bronchospasm, peripheral vasodilation, supraventricular tachycardia, tongue ulcer
There was a 67% decline in albuterol clearance in patients with CrCl 7 to 53 mL/minute.
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 2016; 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.
- 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: 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:
- Lactose: Powder for oral inhalation contains 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.
C
Adverse events have been observed in some animal reproduction studies. 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). Albuterol is the preferred short acting beta agonist when treatment for asthma is needed during pregnancy (NAEPP, 2005; NAEPP, 2007).
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. Use of the injection (Canadian product; not available in the U.S.) is specifically contraindicated in women during the first or second trimester who may be at risk of threatened abortion.
Relaxes bronchial smooth muscle by action on beta2-receptors with little effect on heart rate
Hepatic to an inactive sulfate
Urine (30% as unchanged drug); feces (<20%)
Peak effect:
Nebulization/oral inhalation: 0.5 to 2 hours
CFC-propelled albuterol: 10 minutes
Inhalation powder: 30 minutes
Ventolin HFA: 25 minutes
Oral: Immediate release: 2 to 3 hours
Nebulization/oral inhalation: 2 to 5 hours; Oral: Immediate release: 4 to 6 hours; Extended release tablets: Up to 12 hours
Inhalation: 3.8 to ~5 hours; Oral: 3.7 to 5 hours
10%
- 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, 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), uncontrolled breathing attack, angina, tachycardia, severe anxiety, severe headache, severe dizziness, passing out, decreased peak flow measurement, 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, difficult urination, or wheezing, coughing, or difficult breathing (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 healthcare 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.