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Albuterol

Pronunciation

Pronunciation

(al BYOO ter ole)

Index Terms

  • AccuNeb
  • Albuterol Sulfate
  • ProAir RespiClick
  • Salbutamol
  • Salbutamol Sulphate
  • Volmax

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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]:

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

Brand Names: U.S.

  • ProAir HFA
  • ProAir RespiClick
  • Proventil HFA
  • Ventolin HFA
  • VoSpire ER

Pharmacologic Category

  • Beta2 Agonist

Pharmacology

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

Metabolism

Hepatic to an inactive sulfate

Excretion

Urine (30% as unchanged drug); feces (<20%)

Onset of Action

Peak effect:

Nebulization/oral inhalation: 0.5 to 2 hours

CFC-propelled albuterol: 10 minutes (peak plasma concentration)

Inhalation powder: 30 minutes (peak plasma concentration)

HFA inhalers: 25 minutes (peak plasma concentration); ~56 minutes (peak FEV1 effect)

Oral: Immediate release: 2 to 3 hours

Duration of Action

Nebulization/oral inhalation: 2 to 6 hours; Oral: Immediate release: 4 to 6 hours; Extended release tablets: Up to 12 hours

Half-Life Elimination

Inhalation: 3.8 to ~5 hours; Oral: 3.7 to 5 hours

Protein Binding

10%

Special Populations: Renal Function Impairment

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

Use: Labeled Indications

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

Exercise-induced bronchospasm: Prevention of exercise-induced bronchospasm

Off Label Uses

Asthma (children younger than 4 years) (metered-dose inhaler)

Current practice standards recommend albuterol MDI in the treatment of intermittent and persistent asthma in children younger than 4 years.

Hyperkalemia (Inhalation)

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]).

Contraindications

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

Injection [Canadian product]: Hypersensitivity to albuterol or any component of the formulation; tachyarrhythmias; risk of abortion during first or second trimester

Dosing: Adult

Bronchospasm:

Inhalation:

Metered-dose inhaler (MDI) or dry powder inhaler (90 mcg/actuation): 2 inhalations every 4 to 6 hours as needed (NAEPP 2007)

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

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 (in combination with corticosteroid therapy): 1 to 2 inhalations 3 to 4 times daily (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: Pediatric

Bronchospasm:

Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation) (NAEPP 2007): Quick relief: Children and Adolescents: Refer to adult dosing.

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

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 (in combination with corticosteroid therapy): 1 inhalation; may increase to maximum of 1 inhalation 4 times daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Dry powder inhaler (200 mcg/inhalation): Ventolin Diskus [Canadian product]: Children ≥4 years and Adolescents: Refer to adult dosing.

Nebulization solution:

Manufacturer's 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

Alternative recommendations (NAEPP 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): Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation):

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: Refer to adult dosing.

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: Refer to adult dosing.

Exercise-induced bronchospasm (prevention): Inhalation:

Metered-dose inhaler or dry powder inhaler (90 mcg/actuation):

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]:

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

Children ≥12 years and Adolescents: Refer to adult dosing.

Dry powder inhaler (200 mcg/inhalation): Ventolin Diskus [Canadian product]: Children ≥4 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

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

Reconstitution

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 in 500 ml of NS, D5W or D5NS. Use within 24 hours.

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.

Inhalation:

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.

Dry powder inhalers:

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.

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.

Storage

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 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)

Drug Interactions

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

Cocaine: 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. Consider therapy modification

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

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. 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

Test Interactions

Increased renin (S), increased aldosterone (S)

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%), 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

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 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. 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: 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: 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.

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)

Pregnancy Risk Factor

C

Pregnancy Considerations

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 US.) is specifically contraindicated in women during the first or second trimester who may be at risk of threatened abortion.

Patient Education

• 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.

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