Xopenex Indications:
XOPENEX® (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.
Important Safety Information:
XOPENEX Inhalation Solution and XOPENEX HFA are contraindicated in patients with a history of hypersensitivity to levalbuterol hydrochloride or levalbuterol tartrate, respectively, racemic albuterol, or any component of the drug product.
Patients receiving the highest dose of XOPENEX brand of levalbuterol should be monitored closely for adverse effects, and the risk of such effects should be balanced against the potential for improved efficacy.
XOPENEX and other β-agonists can cause paradoxical bronchospasm, which may be life threatening.
Potential drug interactions include: β-blockers, which can block the pulmonary effect of β-agonists and can cause severe bronchospasm in asthmatic patients; diuretics (non-potassium-sparing), whose ECG changes and/or hypokalemia side effects can worsen with administration of β-agonists; digoxin, where serum levels can decrease 16% to 22% with administration of β-agonists; monoamine oxidase inhibitors and tricyclic antidepressants, which can potentiate the action of albuterol on the vascular system.
If additional adrenergic drugs, including other short-acting sympathomimetic bronchodilators or epinephrine, are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Due to the cardiovascular side effects associated with β-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), diabetes, hyperthyroidism, or convulsive disorders.
Most common adverse events for XOPENEX Inhalation Solution
In patients aged 6 to 11 years, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX Inhalation Solution at either 0.31 mg or 0.63 mg and more frequently than patients
receiving placebo) were headache, rhinitis, pharyngitis, asthma, fever, viral infection, rash, accidental injury, diarrhea, asthenia, lymphadenopathy, and urticaria.
In patients 12 years and older, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX Inhalation Solution at either 0.63 mg or 1.25 mg and more frequently than patients receiving placebo) were viral infection, rhinitis, nervousness, tremor, flu syndrome, sinusitis, accidental injury, anxiety, cough increased, pain, tachycardia, turbinate edema, migraine, dizziness, dyspepsia, and leg cramps.
Most common adverse events for XOPENEX HFA
In patients aged 4 to 11 years, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX HFA at 90 mcg and more frequently than patients receiving placebo) were vomiting, accidental injury, pharyngitis, and bronchitis.
In patients 12 years and older, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX HFA at 90 mcg and more frequently than patients receiving placebo) were asthma, pharyngitis, rhinitis, pain, and dizziness.
For additional information, please see the full Prescribing Information for Xopenex Inhalation Solution or Xopenex HFA.