The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
- 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
- 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 17.4ߙng•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.
Special PopulationsRenal Function Impairment
Use high doses with caution.Children
AUC increases; use lower dose (6 to 11 yr of age).
Indications and Usage
Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease.
Hypersensitivity to levalbuterol or racemic albuterol.
Dosage and AdministrationAdults and children 12 yr of age and older
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 0.63ߙmg 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.
- Administer only via nebulizer. Not for injection or oral use.
- Medication requires no dilution before administration and is added directly into the nebulizer reservoir.
- Once vial has been opened, administer immediately or discard.
- Discard solution if not colorless.
- Discard any unused solution.
- Do not mix with other nebulized medications unless ordered by health care provider.
- Xopenex HFA
- Shake well before using.
- Prime inhaler before using for the first time and when the inhaler has not been used for more than 3 days by releasing 4 test sprays into the air, away from the face.
- Store inhaler with actuator (or mouthpiece) down.
- Wash and dry actuator at least once/wk.
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.
Drug InteractionsBeta-blockers (eg, propranolol)
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.
Laboratory Test Interactions
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).
DermatologicXopenex Children 6 to 11 yr of age
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%).
Hematologic-LymphaticXopenex Children 6 to 11 yr of age
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.
Special Risk Patients
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.
Deterioration of asthma
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.
- Advise patient to review illustrated patient information leaflet. Ensure that patient, family, or caregiver can prepare, use, and clean the nebulizer without difficulty.
- Instruct patient not to mix nebulizer medications unless advised by health care provider.
- Instruct patient to use nebulizer solution immediately after opening. If solution is not used immediately, advise patient to discard the solution.
- Advise patient to discard any unused nebulizer solution.
- Advise patient to shake the inhalation aerosol well before using.
- Advise patient to keep the activator clean by washing it at least once a week.
- Instruct patient not to exceed prescribed dose. Advise patient to contact health care provider if this medication no longer seems to control asthma symptoms or if increasing doses of the medicine are needed. These may indicate worsening asthma.
- Advise patients using more than 1 inhaled medication to use this medication first if needed. Take inhaled corticosteroids or other inhaled controller medications last.
- Advise patient that if breathing symptoms worsen during or immediately after using this medication, to stop using it and inform health care provider immediately.
- Inform patient that levalbuterol is not a substitute for inhaled or oral corticosteroids and not to stop or reduce the dose of corticosteroid medication.
- Instruct patient to discontinue use and immediately notify health care provider if eye pain or discomfort, blurred vision, vision halos, or colored images develop in association with red eyes. Advise patient that these symptoms may be associated with a serious problem that will require immediate medical care.
- Advise patient to carry medical identification (eg, card, bracelet) indicating asthma or COPD.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.