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Treatment or prevention of bronchospasm in adults and adolescents 6 years of age with reversible obstructive airway disease
Teratogenic effects were not observed in animal studies; however, racemic albuterol was teratogenic in some species. There are no studies in pregnant women. This drug should be used during pregnancy only if benefit exceeds risk. Use caution if needed for bronchospasm during labor and delivery; has potential to interfere with uterine contractions.
Excretion in breast milk unknown/use caution
Hypersensitivity to levalbuterol, albuterol, or any component of the formulation
Optimize anti-inflammatory treatment before initiating maintenance treatment with levalbuterol. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest form of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines. Patient 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.
Use caution in patients with cardiovascular disease (arrhythmia or hypertension or CHF), convulsive disorders, diabetes, glaucoma, hyperthyroidism, or hypokalemia. Beta agonists may cause elevation in blood pressure, heart rate, and result in CNS stimulation/excitation. Beta2 agonists may increase risk of arrhythmia, increase serum glucose, or decrease serum potassium.
Do not exceed recommended dose; serious adverse events including fatalities, have been associated with excessive use of inhaled sympathomimetics. Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. Use with caution during labor and delivery. Safety and efficacy have not been established in patients <6 years of age.
Events reported include those 2% with incidence higher than placebo in patients 12 years of age.
Endocrine & metabolic: Serum glucose increased, serum potassium decreased
Respiratory: Viral infection (7% to 12%), rhinitis (3% to 11%)
>2% to 10%:
Central nervous system: Nervousness (3% to 10%), tremor (
Cardiovascular: Tachycardia (~3%)
Gastrointestinal: Dyspepsia (1% to 3%)
Neuromuscular & skeletal: Leg cramps (
Respiratory: Cough (1% to 4%), nasal edema (1% to 3%), sinusitis (1% to 4%)
Miscellaneous: Flu-like syndrome (1% to 4%), accidental injury (
<2%: Abnormal ECG, asthma exacerbation, chest pain, chills, diaphoresis, diarrhea, dyspepsia, gastroenteritis, hypertension, hypesthesia (hand), hypokalemia, hypotension, insomnia, itching eyes, lymphadenopathy, myalgia, nausea, oropharyngeal dryness, paresthesia, syncope, tremor, vomiting, wheezing; immediate hypersensitivity reactions have occurred (including angioedema, oropharyngeal edema, urticaria, rash, and anaphylaxis)
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.
Anesthetics (inhaled): Cardiac effects of levalbuterol may be potentiated; use with caution.
Beta-blockers (particularly nonselective agents): May block the effect of levalbuterol and also produce severe bronchospasm.
Diuretics (nonpotassium-sparing): ECG changes and/or hypokalemia may result from concomitant use; use caution.
Digoxin: Plasma levels of digoxin may be decreased by 16% to 22%; monitor.
MAO inhibitors: Cardiac effects of levalbuterol may be potentiated; use with extreme caution or within 2 weeks of discontinuing MAO inhibitor.
Sympathomimetics (including amphetamine, dobutamine): Cardiac effects of levalbuterol may be potentiated; use with caution.
Tricyclic antidepressants (TCAs): Cardiac effects of levalbuterol may be potentiated; use with extreme caution or within 2 weeks of discontinuing TCAs
Store in protective foil pouch at room temperature of 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat. Vials should be used within 2 weeks after opening protective pouch. Use within 1 week and protect from light if removed from pouch. Vials of concentrated solution should be used immediately after removing from protective pouch. Concentrated solution should be diluted with 2.5 mL NS prior to use.
Relaxes bronchial smooth muscle by action on beta-2 receptors with little effect on heart rate
Onset of action: 10-17 minutes (measured as a 15% increase in FEV1)
Peak effect: 1.5 hours
Duration: 5-6 hours (up to 8 hours in some patients)
Absorption: A portion of inhaled dose is absorbed to systemic circulation
Half-life elimination: 3.3-4 hours
Time to peak, serum: 0.2 hours
Children 6-11 years: 0.31 mg 3 times/day via nebulization (maximum dose: 0.63 mg 3 times/day)
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®, Dura-Neb® 2000, and Dura-Neb® 3000. Concentrated solution should be diluted prior to use.
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)
Use only when necessary or as prescribed; tolerance may develop with overuse. Do not administer more frequently than prescribed. First dose should not be used when you are alone. Avoid OTC medications without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Stress or excessive exercising may exacerbate wheezing or bronchospasm (controlled breathing or relaxation techniques may help). If you have diabetes, you will need to monitor serum glucose levels closely until response is known; notify diabetic advisor if hyperglycemia occurs. You may experience tremor, anxiety, dizziness (use caution when driving or engaging in hazardous activities until response to drug is known); or temporarily upset stomach, nausea, or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking hard candy may help). Paradoxical bronchospasm can occur. Stop drug immediately and notify prescriber if any of the following occur: chest pain, tightness, palpitations; severe headache; respiratory difficulty; increased nervousness, restlessness, or trembling; muscle cramps or weakness; or seizures. Report unusual signs of flu or infection, leg or muscle cramps, unusual cough, persistent GI problems, vision changes, or other adverse effects. Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.Pregnancy/breast-feeding precautions:
No significant effects or complications reported
No information available to require special precautions
May cause nervousness, anxiety, and dizziness; may rarely cause insomnia
Effects of anxiolytics may be ameliorated; cardiac effects may be potentiated with MAO inhibitors and TCAs
Solution for nebulization: 0.31 mg/3 mL (24s); 0.63 mg/3 mL (24s); 1.25 mg/3 mL (24s)
Solution for nebulization, concentrate: 1.25 mg/0.5 mL (30s)
National Asthma Education and Prevention Program, "Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma," Bethesda, MD, National Institutes of Health, 1997. NIH publication 97-4051.
National Asthma Education and Prevention Program, "Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics - 2002,"J Allergy Clin Immunol, 2002, 110(5 Suppl):141-219.