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Click here to download the XOPENEX HFA® Package Insert.
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©2007 Sepracor Inc. All rights reserved |
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Important Safety Information
XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any component of XOPENEX HFA. XOPENEX HFA and other β-agonists can produce paradoxical bronchospasm, which may be life threatening. 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. Do not exceed the recommended dose. Fatalities have been reported in association with excessive use of sympathomimetic drugs in patients with asthma. Please refer to the full prescribing information regarding potential drug interactions with β-blockers, diuretics, digoxin, or MAOI and tricyclic antidepressants.
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.
