Beta₂ Agonist

Treatment or prevention of bronchospasm in adults and adolescents 12 years of age and older with reversible obstructive airway disease.

C

There are no studies in pregnant women. This drug should be used during pregnancy only if benefit exceeds risk.

Patients with known hypersensitivity to levalbuterol or any of the formulation's components

May provoke paradoxical bronchospasm (similar to other bronchodilators). Immediate hypersensitivity reactions have occurred, including angioedema, oropharyngeal edema, urticaria, rash, and anaphylaxis. Use with caution in patients with cardiovascular disease, including coronary artery disease, hypertension and a history of arrhythmias (may increase heart rate, blood pressure or other symptoms, including EKG changes). Do not use doses higher than recommended - fatalities have been associated with excessive use of other sympathomimetics. The need to use bronchodilators more frequently than usual should prompt an evaluation of the need for additional anti-inflammatory medication. Additional anti-inflammatory medication (such as corticosteroids) may be required to control asthma. Use with caution in diabetic patients and in patients with hypokalemia. Use with caution during labor and delivery. Safety and efficacy in patients <12 years of age not established.

Events reported include those greater than or equal to 2% with incidence higher than placebo.

Endocrine and metabolic: Increased serum glucose, decreased serum potassium

Respiratory: Viral infection (6.9% to 12.3%), rhinitis (2.7% to 11.1%)

>2% to <10%:

Central nervous system: Nervousness (2.8% to 9.6%), tremor (0 to 6.8%), anxiety (0 to 2.7%), dizziness (1.4% to 2.7%), migraine (0 to 2.7%), pain (1.4% to 2.8%)

Cardiovascular: Tachycardia (2.7% to 2.8%)

Respiratory: Cough (1.4% to 4.1%), nasal edema (1.4% to 2.8%), sinusitis (1.4% to 4.2%)

Gastrointestinal: Dyspepsia (1.4% to 2.7%)

Neuromuscular & skeletal: Leg cramps (0 to 2.7%)

Miscellaneous: Flu-like syndrome (1.4% to 4.2%), accidental injury (0 to 2.7%)

<2%: Chills, chest pain, abnormal EKG, hypertension, hypotension, syncope, diarrhea, oropharyngeal dryness, dyspepsia, gastroenteritis, nausea, lymphadenopathy, myalgia, anxiety, hypesthesia (hand), insomnia, paresthesia, itching eyes, asthma exacerbation, wheezing, sweating, vomiting

Symptoms of overdose include tachycardia, tremor, hypertension, angina and seizures. Hypokalemia also may occur. Cardiac arrest and death may be associated with abuse of beta-agonist bronchodilators. Treatment includes immediate discontinuation and symptomatic and supportive therapies. Cautious use of beta-adrenergic blocking agents may be considered in severe cases.

Decreased effect: Beta-blockers (particularly nonselective agents) block the effect of levalbuterol. Digoxin levels may be decreased.

Increased effect/toxicity: May add to effects of medications which deplete potassium (eg, loop or thiazide diuretics). Cardiac effects may be potentiated in patients receiving MAOIs, tricyclic antidepressants, sympathomimetics (eg, amphetamine, dobutamine), inhaled anesthetics (eg, enflurane)

Store in protective foil pouch at room temperature (15°C to 25°C; 59°F to 77°F). Protect from light and excessive heat. Vials should be used within two weeks after removal from protective pouch.

Relaxes bronchial smooth muscle by action on beta-2 receptors with little effect on heart rate

Onset: 10-17 minutes (measured as a 15% increase in FEV₁); peak effect: 1.5 hours

Duration: 5-6 hours (as long as 8 hours in some patients)

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

Half-life: 3.3-4.0 hours

Time to peak serum concentration: 0.2 hours

Pediatric: Safety and efficacy in patients <12 years of age not established.

Children >12 years and Adults: Inhalation: 0.63 mg 3 times/day at intervals of 6-8 hours, via nebulization. Dosage may be increased to 1.25 mg 3 times/day with close monitoring for adverse effects. Most patients gain optimal benefit from regular use

Elderly: Only a small number of patients have been studied. Although greater sensitivity of some elderly patients cannot be ruled out, no overall differences in safety or effectiveness were observed. An initial dose of 0.63 mg should be used in all patients >65 years of age.

Administered ONLY via nebulization. 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®, and Dura-Neb® 2000.

Asthma symptoms, FEV₁ and/or peak expiratory flow rate, heart rate, blood pressure, CNS status, arterial blood gases (if condition warrants). In selected patients: Serum, glucose, and potassium

No information available to require special precautions

No effects or complications reported

If a previously effective regimen fails to provide expected relief, medical advice should be sought immediately.

Solution, inhalation: 0.63 mg/3 mL, 1.25 mg/3 mL