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Important Safety Information
Patients receiving the highest dose of XOPENEX® (levalbuterol HCl) Inhalation Solution should be monitored closely for adverse effects, and the risk of such effects should be balanced against the potential for improved efficacy.
XOPENEX Inhalation Solution and XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol 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. XOPENEX® brand of levalbuterol and other β-agonists can cause paradoxical bronchospasm, which may be life threatening: see the accompanying prescribing information regarding potential drug interaction with β-blockers, diuretics, digoxin, or MAOI and tricyclic antidepressants. 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.
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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.
XOPENEX HFA Inhalation Aerosol
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.
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