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Levalbuterol: Drug information

Levalbuterol: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Levalbuterol: Patient drug information" and "Levalbuterol: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Xopenex Concentrate [DSC];
  • Xopenex HFA;
  • Xopenex [DSC]
Pharmacologic Category
  • Beta2 Agonist
Dosing: Adult

Note: 1.25 mg of levalbuterol base is equivalent to 2.5 mg of albuterol (Ref). Nebulized therapy may be preferred for patients who cannot effectively use an inhaler (Ref).

Asthma, acute exacerbation

Asthma, acute exacerbation:

Mild to moderate exacerbations (initial home management): Note: Patients with worsening symptoms despite initial care should seek immediate medical attention (Ref).

Metered-dose inhaler (45 mcg/actuation): Oral inhalation: 2 to 4 inhalations with spacer every 20 minutes for 3 doses, then every 1 to 4 hours based on response and tolerability (Ref).

Nebulization solution: Oral inhalation: 1.25 mg every 20 minutes for 3 doses, then every 1 to 4 hours based on response and tolerability (Ref).

Moderate to severe exacerbations (management in primary or acute care settings): Note: For moderate to severe exacerbations, use in combination with an inhaled short-acting muscarinic antagonist and other adjunctive therapies. For patients who have more severe symptoms or who cannot effectively use an inhaler, nebulized therapy may be preferred (Ref).

Metered-dose inhaler (45 mcg/actuation): Oral inhalation: Initial: 4 inhalations with spacer every 20 minutes for 3 doses, then taper based on response and tolerability (eg, to 2 to 4 inhalations every 1 to 4 hours as needed). If insufficient response, may increase to 6 or 8 inhalations/dose (Ref).

Nebulization solution: Oral inhalation: 1.25 to 2.5 mg every 20 minutes for 3 doses, then every 1 to 4 hours as needed based on response and tolerability (Ref).

Asthma, intermittent symptom relief

Asthma, intermittent symptom relief (alternative agent): Note: Use in combination with an inhaled corticosteroid (preferred; may also be used alone) on an as-needed basis (reliever therapy) rather than regularly scheduled. For maintenance therapy, additional maintenance treatments should be used (Ref).

Metered-dose inhaler (45 mcg/actuation): Oral inhalation: 2 inhalations with spacer every 4 to 6 hours as needed; in some patients, 1 inhalation every 4 hours as needed may be sufficient (maximum dose: 2 inhalations every 4 hours).

Nebulization solution: Oral inhalation: Initial: 0.63 mg to 1.25 mg every 6 to 8 hours as needed, up to 3 doses per 24 hours (maximum dose: 1.25 mg 3 times daily) (Ref).

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease:

Acute exacerbation: Note: Optimal dosing not well defined. Although similar efficacy exists among formulations, some experts prefer nebulized therapy during severe chronic obstructive pulmonary disease exacerbations (Ref). May combine with an inhaled short-acting muscarinic antagonist (Ref).

Nebulization solution: Oral inhalation: 0.63 to 1.25 mg every 1 hour for 2 to 3 doses, then every 2 to 4 hours as needed (Ref).

Metered-dose inhaler (45 mcg/actuation): Oral inhalation: 1 to 2 inhalations every 1 hour for 2 to 3 doses, then every 2 to 4 hours as needed; for patients requiring emergency department or hospital-based care, may increase to 4 inhalations every hour for 2 to 3 doses. For patients requiring mechanical ventilation, up to 8 inhalations may be used if needed (Ref).

Intermittent symptom relief: Note: Use for intermittent symptoms on an as-needed basis rather than regularly scheduled maintenance therapy. Typically used in combination with inhaled short-acting muscarinic antagonist; combination therapy provides greater improvement in FEV1 and symptoms over monotherapy short-acting beta-2 agonist (Ref).

Metered-dose inhaler (45 mcg/actuation): Oral inhalation: 2 inhalations every 4 to 6 hours as needed; in some patients, 1 inhalation every 4 to 6 hours may be sufficient (maximum dose: 2 inhalations every 4 hours).

Nebulization solution: Oral inhalation: 0.63 mg 3 times daily at intervals of 6 to 8 hours as needed; dosage may be increased to 1.25 mg 3 times daily as needed with close monitoring for adverse effects (maximum dose: 1.25 mg 3 times daily) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Use high doses with caution; drug clearance is decreased.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing, starting with lowest dose; titrate cautiously.

Dosing: Pediatric

(For additional information see "Levalbuterol: Pediatric drug information")

Asthma

Asthma: Note: Scheduled daily levalbuterol use is not recommended for long-term maintenance treatment (Ref). Increasing use or regular use >2 days/week for symptom control (except prevention of exercise-induced bronchospasm) indicates inadequate control and need for additional long-term control therapy (Ref).

Acute symptom relief: Note: For use as an as-needed reliever therapy for acute symptoms outside of an exacerbation; beta agonists should be used in combination with inhaled corticosteroids (ICS) for acute symptom relief in select patients ≥4 years of age; this may be accomplished by either administering as-needed albuterol immediately followed by ICS or using a combination ICS and formoterol inhaler (Ref).

Metered-dose inhaler: 45 mcg/actuation:

Children ≥4 years and Adolescents: Oral inhalation: 2 inhalations every 4 to 6 hours as needed (Ref); 1 inhalation every 4 hours may be sufficient in some patients; maximum dose: 2 inhalations every 4 hours (Ref).

Nebulization: Limited data available in ages <6 years:

Infants and Children ≤4 years: Oral inhalation: 0.31 to 1.25 mg every 4 to 6 hours as needed (Ref).

Children 5 to <12 years: Oral inhalation: 0.31 to 0.63 mg every 8 hours as needed (Ref).

Children ≥12 years and Adolescents: Oral inhalation: 0.63 to 1.25 mg every 6 to 8 hours as needed for up to 3 doses per 24 hours (Ref).

Acute exacerbation: Note: Use for progressively worsening asthma symptoms not responding to as-needed reliever therapy. Beta agonists are often used in conjunction with systemic glucocorticoids in patients with acute exacerbations.

Home management: Note: Patients with severe symptoms or worsening symptoms despite initial care should seek immediate medical attention.

Metered-dose inhaler: 45 mcg/actuation:

Children ≥4 years and Adolescents: Oral inhalation: 2 to 4 inhalations every 20 minutes as needed for 2 to 3 doses; patients with more severe symptoms may require up to 6 inhalations/dose (Ref); if initial response is good, lengthen dosing frequency and administer 2 to 6 inhalations every 3 to 4 hours for 24 to 48 hours (Ref).

Nebulization: Limited data available in ages <6 years:

Infants and Children: Oral inhalation: Usual dose: 0.63 to 1.25 mg every 20 minutes for 3 doses if needed (Ref); if initial response is good, lengthen dosing frequency and administer 0.63 to 1.25 mg every 3 to 4 hours for 24 to 48 hours; reported range: 0.31 to 1.25 mg/dose (Ref).

Adolescents: Oral inhalation: Usual dose: 1.25 mg every 20 minutes for 3 doses if needed (Ref); if initial response is good, lengthen dosing frequency and administer 1.25 mg every 3 to 4 hours for 24 to 48 hours; reported range: 0.63 to 2.5 mg/dose (Ref).

Primary care/acute care management:

Metered-dose inhaler: 45 mcg/actuation: Infants, Children, and Adolescents (limited data available in ages <4 years): Oral inhalation: 4 to 8 inhalations every 20 minutes for 3 doses, then every 1 to 4 hours (Ref).

Nebulization (Ref): Note: Nebulization is preferred for patients who are unable to effectively use a metered-dose inhaler due to age, agitation, or severity of the exacerbation (Ref). For severe exacerbations, addition of ipratropium may be considered if poor response to initial aggressive short-acting beta2-agonist (SABA) therapy in an acute care setting (ie, emergency department). Ipratropium has not been shown to provide further benefit (eg, after first 24 hours) once the patient is hospitalized (Ref).

Infants and Children: 0.075 mg/kg/dose (minimum dose: 1.25 mg/dose; maximum dose: 2.5 mg/dose) every 20 minutes for 3 doses, then 0.075 to 0.15 mg/kg/dose (maximum dose: 5 mg/dose) every 1 to 4 hours as needed.

Adolescents: 1.25 to 2.5 mg every 20 minutes for 3 doses, then 1.25 to 5 mg every 1 to 4 hours as needed.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use high doses with caution; drug clearance is decreased.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (children: 12%)

Gastrointestinal: Vomiting (children: 11%)

Infection: Viral infection (≤12%)

Respiratory: Rhinitis (6% to 11%)

>2% to 10%:

Cardiovascular: Tachycardia (adolescents and adults: 3%)

Central nervous system: Nervousness (adolescents and adults: 3% to 10%), dizziness (adolescents and adults: 3%), migraine (adolescents and adults: 3%), anxiety (adolescents and adults: ≤3%), pain (adolescents and adults: ≤3%)

Dermatologic: Skin rash (children: 8%), urticaria (children: 3%)

Gastrointestinal: Diarrhea (children: 2% to 6%; adolescents and adults: <2%), dyspepsia (adolescents and adults: ≤3%)

Hematologic & oncologic: Lymphadenopathy (≤3%)

Neuromuscular & skeletal: Tremor (adolescents and adults: ≤7%), leg cramps (adolescents and adults: ≤3%), weakness (children: 3%), myalgia (≤2%)

Respiratory: Pharyngitis (7% to 10%), asthma (9%), cough (adolescents and adults: 4%), sinusitis (adolescents and adults: 4%), flu-like symptoms (adolescents and adults: ≤4%), bronchitis (children: 3%), nasal mucosa swelling (1% to 3%)

Miscellaneous: Fever (children: 9%), accidental injury (children 5% to 9%; adolescents and adults: 3%)

Frequency not defined:

Endocrine & metabolic: Decreased serum potassium, increased heart rate, increased serum glucose, paradoxical bronchospasm

Hypersensitivity: Hypersensitivity reaction (including bronchospasm, oropharyngeal edema)

<2%, postmarketing, and/or case reports: Acne vulgaris, anaphylaxis, angina pectoris, angioedema, atrial fibrillation, cardiac arrhythmia, chest pain, chills, constipation, conjunctivitis, dry throat, dysmenorrhea, dyspnea, ECG abnormality, epistaxis, extrasystoles, eye pruritus, gastroenteritis, gastroesophageal reflux disease, hematuria, hyperesthesia (hand), hypertension, hypokalemia, hypotension, insomnia, metabolic acidosis, nausea, otalgia, paresthesia, pulmonary disease, supraventricular cardiac arrhythmia, syncope, vertigo, voice disorder, vulvovaginal candidiasis, xerostomia

Contraindications

Hypersensitivity to levalbuterol, albuterol, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Rarely, life-threatening paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. Discontinue immediately and treat with an alternative therapy. Paradoxical bronchospasm is frequently associated with first use of a new canister or vial.

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

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, or hypertension); beta agonists may cause elevation in blood pressure and heart rate and result in CNS stimulation/excitation. Beta-2 agonists may also increase risk of arrhythmias and electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.

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

• 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; drug clearance is decreased.

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

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.

Dosage Forms Considerations

Xopenex HFA 15 g canisters contain 200 inhalations.

Dosage Forms: US

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

Aerosol, Inhalation, as tartrate [strength expressed as base]:

Xopenex HFA: 45 mcg/actuation (15 g)

Generic: 45 mcg/actuation (15 g)

Nebulization Solution, Inhalation, as hydrochloride [strength expressed as base]:

Generic: 0.31 mg/3 mL (3 mL); 0.63 mg/3 mL (3 mL); 1.25 mg/3 mL (3 mL); 1.25 mg/0.5 mL (1 ea, 30 ea)

Nebulization Solution, Inhalation, as hydrochloride [strength expressed as base, preservative free]:

Xopenex: 0.31 mg/3 mL (3 mL [DSC]); 0.63 mg/3 mL (3 mL [DSC]); 1.25 mg/3 mL (3 mL [DSC])

Xopenex Concentrate: 1.25 mg/0.5 mL (1 ea [DSC], 30 ea [DSC])

Generic: 0.31 mg/3 mL (3 mL); 0.63 mg/3 mL (3 mL); 1.25 mg/3 mL (3 mL); 1.25 mg/0.5 mL (1 ea, 30 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Aerosol (Levalbuterol Tartrate Inhalation)

45 mcg/ACT (per gram): $4.91

Aerosol (Xopenex HFA Inhalation)

45 mcg/ACT (per gram): $5.73

Nebulization (Levalbuterol HCl Inhalation)

0.31 mg/3 mL (per mL): $0.67 - $2.24

0.63 mg/3 mL (per mL): $0.67 - $2.24

1.25 mg/0.5 mL (per each): $6.70

1.25 mg/3 mL (per mL): $0.67 - $2.24

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.

Administration: Adult

Inhalation: For oral inhalation only.

Metered-dose inhaler: Shake well before use, avoid spraying in the eyes. Prime with 4 test sprays prior to first use or if inhaler has not been used for more than 3 days. Clean actuator (mouthpiece) weekly with warm water and air dry thoroughly. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler. Each inhaler contains 200 actuations, discard when the display window shows zero.

Nebulization solution: Safety and efficacy were established when administered with the following nebulizers: PARI LC Jet, PARI LC Plus, as well as the following compressors: PARI Master, Dura-Neb 2000, and Dura-Neb 3000. Concentrated solution should be diluted prior to use. Compatibility with other medications (eg, budesonide, ipratropium) in nebulizer has been reported (Ref); also refer to institution-specific policies. 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 children <4 years of age, a face mask with either the metered-dose inhaler or nebulizer is recommended (Ref).

Metered-dose inhaler: Shake well before use. Prime the inhaler (before first use or if it has not been used for more than 3 days) by releasing 4 test sprays into the air away from the face. Use with a valved spacer in patients ≤5 years of age and spacer with a mask for patients <3 years of age or until proper technique is demonstrated (Ref). Clean actuator (mouthpiece) at least weekly with warm water and air dry thoroughly. The dose indicator tells you how many doses are left; do not immerse cannister in water or use "float test" to determine number of inhalations left. When the indicator turns red and reads "20", the patient should contact the pharmacy for a refill. Discard inhaler when the dose indicator window displays "0".

Nebulization: Dilution required for concentrated solution. Safety and efficacy were established when administered with the following nebulizers: PARI LC Jet, PARI LC Plus, as well as the following compressors: PARI Master, Dura-Neb 2000, and Dura-Neb 3000. Blow-by administration is not recommended, use a mask device if patient unable to hold mouthpiece in mouth for administration. Compatibility with other medications (eg, budesonide, ipratropium) in nebulizer has been reported (Ref); also refer to institution-specific policies.

Use: Labeled Indications

Bronchospasm: Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease (eg, asthma).

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

Xopenex may be confused with Xanax

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Beta2-Agonists (Short-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Short-Acting). Management: Avoid coadministration of more than one short-acting beta2-agonist whenever possible. If combined, use cautiously, and monitor for increased toxicities, particularly cardiovascular effects (eg, tachycardia, arrhythmias). Risk D: Consider therapy modification

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

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. 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

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. 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

Methacholine: Beta2-Agonists (Short-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold short-acting beta2 agonists for 6 hours before methacholine use. Risk D: Consider therapy modification

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

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. 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

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. 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

Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. 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

Pregnancy Considerations

Maternal use of beta2 agonists is not associated with an increased risk of fetal malformations (GINA 2023).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth and gestational diabetes) (ERS/TSANZ [Middleton 2019]; GINA 2023).

Pregnant patients should be treated with a short-acting beta-2 agonist (SABA) for acute asthma exacerbations (GINA 2023). Maternal asthma symptoms should be monitored monthly (ERS/TSANZ [Middleton 2020], GINA 2023). If high doses of a SABA are required within 48 hours of delivery, monitoring of glucose concentrations in the newborn for 24 hours is recommended, especially in preterm infants (GINA 2023). Levalbuterol is not approved for the management of preterm labor.

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or http://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

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

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of exposure to the infant, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

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

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Onset of action (as measured by a 15% increase in FEV1):

Metered-dose inhaler: 5.5 to 10.2 minutes; Peak effect: 76 to 78 minutes

Nebulization solution: 10 to 17 minutes; Peak effect: 1.5 hours

Duration (as measured by a 15% increase in FEV1):

Metered-dose inhaler: 3 to 4 hours (up to 6 hours in some patients)

Nebulization solution: 5 to 6 hours (up to 8 hours in some patients)

Absorption: A portion of inhaled dose is absorbed to systemic circulation

Metabolism: Metabolized primarily in the gastrointestinal tract via SULT1A3 (sulfotransferase)

Half-life elimination: 3.3 to 4 hours

Time to peak, serum: Nebulization solution: Children: 0.3 to 0.6 hours, Adults: 0.2 hours

Excretion: Urine (80% to 100%), feces (<20%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Racemic albuterol clearance decreased by 67% in patients with creatinine clearance of 7 to 53 mL/minute.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Xopenex hfa;
  • (AR) Argentina: Ventoplus | Ventoplus nebu;
  • (BD) Bangladesh: Pulmocare l;
  • (CO) Colombia: Levacort;
  • (EC) Ecuador: Rescuwave ls;
  • (IN) India: Aerozest | Airlevo | Ibires nexhaler | Levolin | Salbair;
  • (KE) Kenya: Levaform | Levolin | Levostar;
  • (LB) Lebanon: Levolin;
  • (PE) Peru: Levomar;
  • (PK) Pakistan: Levhale;
  • (PR) Puerto Rico: Levalbuterol tartrate hfa;
  • (UG) Uganda: Levolin
  1. Bisgaard H, Le Roux P, Bjåmer D, Dymek A, Vermeulen JH, Hultquist C. Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma. Chest. 2006;130(6):1733-1743. doi:10.1378/chest.130.6.1733 [PubMed 17166990]
  2. Burchett DK, Darko W, Zahra J, Noviasky J, Probst L, Smith A. Mixing and compatibility guide for commonly used aerosolized medications. Am J Health Syst Pharm. 2010;67(3):227-230. doi:10.2146/ajhp080261 [PubMed 20101066]
  3. Cahill KN. Acute exacerbations of asthma in adults: emergency department and inpatient management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed December 8, 2021.
  4. Donohue JF, Parsey MV, Andrews C, et al; Levalbuterol COPD Study Group. Evaluation of the efficacy and safety of levalbuterol in subjects with COPD. COPD. 2006;3(3):125-132. doi:10.1080/15412550600829190 [PubMed 17240614]
  5. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Updated 2021. Accessed December 8, 2021.
  6. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/2023-gina-main-report/. Updated 2023. Accessed August 23, 2023.
  7. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for prevention, diagnosis and management of COPD: 2023 report. https://goldcopd.org/2023-gold-report-2/. Updated 2023. Accessed January 30, 2023.
  8. Hardasmalani MD, DeBari V, Bithoney WG, Gold N. Levalbuterol versus racemic albuterol in the treatment of acute exacerbation of asthma in children. Pediatr Emerg Care. 2005;21(7):415-419. doi:10.1097/01.pec.0000169433.91196.6a [PubMed 16027572]
  9. Kamin W, Erdnüss F, Krämer I. Inhalation solutions--which ones may be mixed? Physico-chemical compatibility of drug solutions in nebulizers--update 2013. J Cyst Fibros. 2014;13(3):243-250. doi:10.1016/j.jcf.2013.09.006 [PubMed 24172851]
  10. Kirenga BJ, Schwartz JI, de Jong C, van der Molen T, Okot-Nwang M. Guidance on the diagnosis and management of asthma among adults in resource limited settings. Afr Health Sci. 2015;15(4):1189-1199. doi:10.4314/ahs.v15i4.18 [PubMed 26958020]
  11. Lemanske RF, Schauberger E. Beta agonists in asthma: acute administration and prophylactic use. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 31, 2021.
  12. Lötvall J, Palmqvist M, Arvidsson P, Maloney A, Ventresca GP, Ward J. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001;108(5):726-731. doi:10.1067/mai.2001.119152 [PubMed 11692096]
  13. Mhanna MJ, Patel JS, Patel S, et al. The Effects of Racemic Albuterol Versus Levalbuterol in Very Low Birth Weight Infants. Pediatr Pulmonol. 2009;44(8):778-783. [PubMed 19598281]
  14. Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2):1901208. doi:10.1183/13993003.01208-2019 [PubMed 31699837]
  15. Milgrom H, Skoner DP, Bensch G, et al. Low-Dose Levalbuterol in Children With Asthma: Safety and Efficacy in Comparison With Placebo and Racemic Albuterol. J Allergy Clin Immunol. 2001;108(6):938-945. [PubMed 11742271]
  16. National Asthma Education and Prevention Program (NAEPP); National Heart, Lung, and Blood Institute. Expert Panel Report 3: Guidelines for the diagnosis and management of asthma. https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthgdln_1.pdf. Published 2007.
  17. National Asthma Education and Prevention Program (NAEPP); National Heart, Lung, and Blood Institute. 2020 focused updates to the asthma management guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/2020-focused-updates-asthma-management-guidelines. Published December 2020.
  18. Refer to manufacturer's labeling.
  19. Roy SR, Milgrom H. Managing outpatient asthma exacerbations. Curr Allergy Asthma Rep. 2003;3(2):179-189. doi:10.1007/s11882-003-0032-7 [PubMed 12562559]
  20. Shenoi RP, Timm N; Committee on Drugs; Committee on Pediatric Emergency Medicine. Drugs used to treat pediatric emergencies. Pediatrics. 2020;145(1):e20193450. [PubMed 31871244]
  21. Stoller JK. COPD exacerbations: management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 22, 2021.
  22. Xopenex (levalbuterol) [prescribing information]. Lake Forest, IL: Akorn; January 2019.
  23. Xopenex HFA (levalbuterol) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc; February 2017.
  24. Xopenex inhalation solution concentrate (levalbuterol) [prescribing information]. Lake Forest, IL: Akorn Inc; January 2019.
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