Trade Names:Xopenex- Solution for inhalation 0.31 mg per 3 mL- Solution for inhalation 0.63 mg per 3 mL- Solution for inhalation 1.25 mg per 3 mL
Trade Names:Xopenex HFA- Aerosol 45 mg levalbuterol per actuation
Produces bronchodilation by relaxing bronchial smooth muscles via beta-2 adrenergic receptor stimulation.
T max is approximately 0.2 h. C max is approximately 1.1 to 4.5 ng/mL (dose dependent). AUC is approximately 3.3 to 17.4 ng•h/mL (dose dependent).Xopenex HFA
T max in adolescents/adults (12 yr of age and older) and children (4 to 11 yr of age) is approximately 0.54 and 0.76 h, respectively. C max in adolescents/adults (12 yr of age and older) and children (4 to 11 yr of age) is approximately 0.199 and 0.163 ng/mL, respectively. AUC in adolescents/adults (12 yr of age and older) and children (4 to 11 yr of age) is approximately 0.695 and 0.579 ng•h/mL, respectively.
The t ½ is approximately 3 to 4 h. Primary route of excretion is renal (80% to 100%) with less than 20% eliminated in the feces.
17 min (0.63 mg); 10 min (1.25 mg).
Approximately 1.5 h.
Approximately 5 to 8 h.
Use high doses with caution.Children
AUC increases; use lower dose (6 to 11 yr of age).
Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease.
Hypersensitivity to levalbuterol or racemic albuterol.
Inhalation solution Xopenex : Usual starting dosage is 0.63 mg 3 times daily (every 6 to 8 h) by nebulization. Patients with more severe asthma or patients who do not respond adequately to the 0.63 mg dose may benefit from 1.25 mg 3 times daily.Children 6 to 11 yr of age
Inhalation solution Xopenex : Recommended dosage is 0.31 mg 3 times daily by nebulization (max, 0.63 mg 3 times daily).Adults and Children 4 yr of age and older
Inhalation aerosol Xopenex HFA : 2 inhalations (90 mcg) repeated every 4 to 6 h. In some patients, 1 inhalation every 4 h is sufficient.
Store unused vials in protective foil pouch between 68° and 77°F. Once the foil pouch is opened, use vials within 2 wk. If vials are removed from pouch and not used immediately, use within 1 wk. Protect vials from light and excessive heat.Xopenex HFA
Store between 68° and 77°F. Protect from freezing and direct sunlight.
Severe bronchospasms may be produced in asthmatic patients taking levalbuterol.Digoxin
Plasma digoxin levels may be decreased.Diuretics (eg, loop [eg, furosemide] and thiazide [eg, hydrochlorothiazide])
ECG changes and hypokalemia associated with diuretic therapy may be worsened by levalbuterol administration.MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline)
The action of levalbuterol on the vascular system may be potentiated.
None well documented.
Migraine, tachycardia (3%).Xopenex HFA
Hypertension (less than 2%); angina; arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles; tachycardia (postmarketing).
Nervousness (10%); tremor (7%); anxiety, dizziness (3%).Children 6 to 11 yr of age
Headache (12%); asthenia (3%).Xopenex HFA
Dizziness (3%); CNS stimulation, headache, sleeplessness; nervousness, tremor (postmarketing).
Rash (8%); urticaria (3%).Xopenex HFA
Acne (less than 2%).
Rhinitis (11%).Children 6 to 11 yr of age
Pharyngitis, rhinitis (10%).Xopenex HFA
Pharyngitis (8%); rhinitis (7%); conjunctivitis, ear pain, epistaxis (less than 2%); drying or irritation of the oropharynx, vertigo.Children 4 to 11 yr of age
Dyspepsia (3%).Children 6 to 11 yr of age
Diarrhea (6%).Xopenex HFA
Constipation, gastroenteritis (less than 2%); nausea (postmarketing).Children 4 to 11 yr of age
Dysmenorrhea, hematuria, vaginal moniliasis (less than 2%).
Leg cramps (3%).Children 6 to 11 yr of age
Myalgia (2%).Xopenex HFA
Myalgia (less than 2%).
Viral infection (12%); increased cough, sinusitis (4%); turbinate edema (3%).Children 6 to 11 yr of age
Asthma (9%).Xopenex HFA
Asthma (9%); lung disorder (less than 2%); dyspnea, increased cough (postmarketing).Children 4 to 11 yr of age
Flu syndrome (4%); accidental injury, pain (3%).Children 6 to 11 yr of age
Fever, viral infection (9%); accidental injury (6%); pain (3%); abdominal pain (2%).Xopenex HFA
Pain (4%); cyst, flu syndrome, herpes simplex, viral infection (less than 2%); anaphylaxis, angioedema, chest pain (postmarketing).Children 4 to 11 yr of age
Accidental injury (9%).
Category C .
Safety and efficacy not established in children younger than 6 yr of age.Xopenex HFA
Safety and efficacy not established in children younger than 4 yr of age.
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Immediate hypersensitivity reactions may occur.
Use with caution in patients with CV disorders, convulsive disorders, hyperthyroidism, or diabetes, and in patients unusually responsive to sympathomimetic amines.
Life-threatening paradoxical bronchospasm may occur.
Clinically important CV effects, as measured by pulse rate and BP, may occur; use with caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
CNS stimulation may occur; use with caution in patients with a history of seizures or hyperthyroidism.
A dosage requirement increase or increased frequency of use may indicate destabilization of asthma, requiring re-evaluation of the treatment regimen.
Use with caution.
Angina, arrhythmias, cardiac arrest, death, dizziness, dry mouth, fatigue, headache, hypertension, hypokalemia, hypotension, malaise, nausea, nervousness, palpitation, seizures, sleeplessness, tachycardia, tremor.
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