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Important Safety Information

XOPENEX® (levalbuterol HCl) Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol HCl or racemic albuterol.

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 other β-agonists can produce paradoxical bronchospasm, which may be life threatening, see the accompanying prescribing information regarding potential drug interactions with β-blockers, diuretics, digoxin, or MAOI and tricyclic antidepressants. Due to the cardiovascular side effects associated with β-agonists, caution should be used for patients with cardiovascular disorders, especially arrhythmias, hypertension, and coronary insufficiency; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitusand in patients who are unusually responsive to sympathomimetic amines.

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.