Classes
DEA Class; Rx
Common Brand Names; Xopenex, Xopenex HFA
- Beta2 Agonists
Description
Moderately selective short-acting beta-2 receptor agonist (SABA); r-enantiomer of racemic albuterol; available as oral inhaler and nebulizer treatment
Used clinically in adult and pediatric patients for acute bronchospasm due to asthma as a reliever therapy and for asthma exacerbations; also used in adults with COPD
Clinical activity similar to racemic albuterol
Indications
Indicated for asthma exacerbation (e.g., primary care or acute care management).
Contraindications
Hypersensitivity to levalbuterol or racemic albuterol
Adverse Effects
- Headache (8-12%)
- Viral infection (7-12%)
- Rhinitis (3-11%)
- Pharyngitis (3-10%)
- Tremor (7%)
- Sinusitis (1-4%)
- Flu (1-4%)
- Dyspepsia (1-3%)
- Leg cramps (<3%)
- Generalized pain (2.8%)
- Nasal edema (2.8%)
- Nervousness (2.8%)
- Tachycardia (2.8%)
Warnings
Risk of paradoxical bronchospasm; this should be distinguished from inadequate response; discontinue and treat with alternate therapy if it occurs
Has higher affinity for beta1- and beta2-adrenergic receptors than racemic albuterol has
Risk of hypersensitivity reactions
Use caution in hyperthyroidism; may increase thyroid activity
Use with caution in diabetes mellitus (beta2 agonists may increase glucose)
Risk of hypokalemia (usually transient); use with caution in hypokalemia
Use with caution in patients with history of seizure disorders; therapy may increase CNS activity/excitation
Exceeding the recommended dose may result in serious adverse effects, including fatalities
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women; there are clinical considerations with use in pregnant women
There are no available data on presence of levalbuterol in human milk, effects on breastfed child, or effects on milk production
Maximum Dosage
2 puffs (MDI) every 4 hours as needed for treatment/prevention of bronchospasm; higher doses may be required acutely during severe exacerbations. For nebulized solution, 1.25 mg/dose given 3 times/day for treatment/prevention of bronchospasm.
2 puffs (MDI) every 4 hours as needed for treatment/prevention of bronchospasm; higher doses may be required acutely during severe exacerbations. For nebulized solution, 1.25 mg/dose given 3 times/day for treatment/prevention of bronchospasm.
2 puffs (MDI) every 4 hours as needed for treatment/prevention of bronchospasm; higher doses may be required acutely during severe asthma exacerbations. For nebulized solution, 1.25 mg/dose given 3 times/day for treatment/prevention of bronchospasm; doses up to 5 mg/dose have been used off-label for acute exacerbations.
12 years: 2 puffs (MDI) every 4 hours as needed for treatment/prevention of bronchospasm; higher doses may be required acutely during severe asthma exacerbations. For nebulized solution, 1.25 mg/dose given 3 times/day for treatment/prevention of bronchospasm; doses up to 5 mg/dose have been used off-label for acute exacerbations.
6 to 11 years: 2 puffs (MDI) every 4 hours as needed for treatment/prevention of bronchospasm; higher doses may be required acutely during severe asthma exacerbations. For nebulized solution, 0.63 mg/dose given 3 times/day for treatment/prevention of bronchospasm; doses up to 0.15 mg/kg/dose (Max: 5 mg/dose) have been used off-label for acute exacerbations.
4 to 5 years: 2 puffs (MDI) every 4 hours as needed for treatment/prevention of bronchospasm; higher doses may be required acutely during severe asthma exacerbations. Safety and efficacy of the nebulized oral solution has not been established; however, doses up to 0.15 mg/kg/dose (Max: 5 mg/dose) have been used off-label for acute exacerbations.
1 to 3 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established; however, 0.31 mg via nebulizer every 8 hours has been used off-label for bronchodilation.
How supplied
Levalbuterol hydrochloride
nebulizer solution
- 0.31mg/3mL
- 0.63mg/3mL
- 1.25mg/3mL
- 1.25mg/0.5mL
aerosol
- 45mcg/actuation